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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently Treated with Basal Insulin (QWINT-3)

Summary
EudraCT number	2021-002569-16
Trial protocol	SK HU ES PL
Global end of trial date	15 May 2024

Results information
Results version number	v1(current)
This version publication date	31 May 2025
First version publication date	31 May 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I8H-MC-BDCU

ISRCTN number

US NCT number

NCT05275400

WHO universal trial number (UTN)

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon Fri 9 AM 5 PM EST, Eli Lilly and Company,, Eli Lilly, 1 877CTLilly,

Scientific contact

Available Mon Fri 9 AM 5 PM EST, Eli Lilly and Company, , Eli Lilly, 1 8772854559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 May 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 May 2024

Was the trial ended prematurely?

Main objective of the trial

To investigate the hypothesis that LY3209590 is noninferior to the comparator (insulin degludec) on glycemic control in study participants with T2D currently on basal insulin

Protection of trial subjects

his study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

08 Mar 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 88

Country: Number of subjects enrolled

Slovakia: 91

Country: Number of subjects enrolled

Spain: 77

Country: Number of subjects enrolled

Hungary: 38

Country: Number of subjects enrolled

Argentina: 155

Country: Number of subjects enrolled

Japan: 141

Country: Number of subjects enrolled

Korea, Republic of: 95

Country: Number of subjects enrolled

Taiwan: 30

Country: Number of subjects enrolled

United States: 271

Worldwide total number of subjects

986

EEA total number of subjects

294

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

602

From 65 to 84 years

383

85 years and over

Subject disposition

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Recruitment details

Participants underwent a 3 week screening and lead-in period, and a 78-week treatment period, followed by a 5-week safety follow-up period.

Screening details

Period 1 title

Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

500 U/mL - Insulin Efsitora

Arm description

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Arm type

Experimental

Investigational medicinal product name

Insulin Efsitora

Investigational medicinal product code

Other name

LY3209590

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously.

100 U/mL - Insulin Degludec

Arm description

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Arm type

Active comparator

Investigational medicinal product name

Insulin Degludec

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously.

Number of subjects in period 1	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Started	655	331
Received At Least 1 Dose of Study Drug	655	331
Completed	593	303
Not completed	62	28
Physician decision	5	4
Consent withdrawn by subject	30	12
Non-Compliance with Study Drug	5	1
Adverse event, non-fatal	7	1
Death	5	2
Sponsor Decision	1	-
Lost to follow-up	1	5
Assigned Treatment by Mistake	6	3
Protocol deviation	1	-
Lack of efficacy	1	-

Period 2 title

Follow-Up Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

500 U/mL - Insulin Efsitora

Arm description

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Arm type

Experimental

Investigational medicinal product name

Insulin Efsitora

Investigational medicinal product code

Other name

LY3209590

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously.

100 U/mL - Insulin Degludec

Arm description

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Arm type

Active comparator

Investigational medicinal product name

Insulin Degludec

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered subcutaneously.

Number of subjects in period 2	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Started	614	306
Completed	608	306
Not completed	6	0
Consent withdrawn by subject	3	-
Death	2	-
Protocol deviation	1	-

Baseline characteristics

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Reporting group title

500 U/mL - Insulin Efsitora

Reporting group description

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Reporting group title

100 U/mL - Insulin Degludec

Reporting group description

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Reporting group values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec	Total
Number of subjects	655	331	986
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	407	195	602
From 65-84 years	247	136	383
85 years and over	1	0	1
Gender categorical
Units: Subjects
Female	279	152	431
Male	376	179	555
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	179	88	267
Not Hispanic or Latino	476	243	719
Unknown or Not Reported	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	2	0	2
Asian	180	92	272
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	32	20	52
White	438	218	656
More than one race	2	1	3
Unknown or Not Reported	0	0	0
Region of Enrollment
Units: Subjects
Argentina	103	52	155
Hungary	24	14	38
Poland	59	29	88
Slovakia	60	31	91
South Korea	64	31	95
Spain	52	25	77
Taiwan	19	11	30
United States	180	91	271
Japan	94	47	141

End points

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Reporting group title

500 U/mL - Insulin Efsitora

Reporting group description

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Reporting group title

100 U/mL - Insulin Degludec

Reporting group description

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Reporting group title

500 U/mL - Insulin Efsitora

Reporting group description

Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).

Reporting group title

100 U/mL - Insulin Degludec

Reporting group description

Participants received 100 U/mL insulin degludec administered SC once daily (QD).

Primary: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]

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End point title

Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]

End point description

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. Analysis Population Description (APD): All participants who received at least one dose of study drug and had evaluable data for this outcome at baseline or week 26. Participants who were assigned treatment by mistake were excluded.

End point type

Primary

End point timeframe

Baseline, Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	649	328
Units: Percentage of HbA1c
least squares mean (standard error)	-0.81 ( 0.0302 )	-0.72 ( 0.0424 )

Outcome Measure No. 1

Statistical analysis description

Noninferiority margin (NIM) was 0.4%

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

977

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

LS Mean Difference

Point estimate

-0.089

Confidence interval

level

95%

sides

2-sided

lower limit

-0.191

upper limit

0.013

Secondary: Nocturnal Hypoglycemia Event Rate

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End point title

Nocturnal Hypoglycemia Event Rate

End point description

The event rate of participant-reported clinically significant glucose <54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. APD: All participants who received at least one dose of study drug.

End point type

Secondary

End point timeframe

Baseline up to Week 78

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	655	331
Units: Events per year
arithmetic mean (standard error)	0.11 ( 0.022 )	0.10 ( 0.019 )

Outcome Measure No. 2

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

986

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.897

Method

Negative Binomial Model

Parameter type

Relative Rate

Point estimate

1.03

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

1.74

Secondary: Percentage of Time in Glucose Range

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End point title

Percentage of Time in Glucose Range

End point description

Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach. APD: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Week 22 to Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	641	325
Units: Percentage of time
least squares mean (standard error)	61.37 ( 0.676 )	60.95 ( 0.954 )

Outcome Measure No. 3

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

966

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.722

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

0.42

Confidence interval

level

95%

sides

2-sided

lower limit

-1.88

upper limit

2.72

Secondary: Change From Baseline in Fasting Glucose

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End point title

Change From Baseline in Fasting Glucose

End point description

Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach. APD: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 26 were included. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	648	327
Units: milligrams per deciliter (mg/dL)
least squares mean (standard error)	-30.97 ( 0.943 )	-30.13 ( 1.323 )

Outcome Measure No. 4

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

975

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.605

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-0.84

Confidence interval

level

95%

sides

2-sided

lower limit

-4.01

upper limit

2.33

Secondary: Weekly Insulin Dose at Week 26

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End point title

Weekly Insulin Dose at Week 26

End point description

The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry. APD: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	647	327
Units: Units per week of insulin
least squares mean (standard error)	333.20 ( 5.93 )	363.20 ( 8.33 )

Outcome Measure No. 5

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

974

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

-30

Confidence interval

level

95%

sides

2-sided

lower limit

-50.1

upper limit

-9.97

Secondary: Hypoglycemia Event Rate

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End point title

Hypoglycemia Event Rate

End point description

Patient reported events of hypoglycemia - Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables. APD: All participants who received at least one dose of study drug.

End point type

Secondary

End point timeframe

Baseline up to Week 78

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	655	331
Units: Events per year
arithmetic mean (standard error)	0.84 ( 0.082 )	0.74 ( 0.098 )

Outcome Measure No. 6

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

986

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.43

Method

Negative Binomial Model

Parameter type

Relative Rate

Point estimate

1.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

1.56

Secondary: Change From Baseline in Body Weight

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End point title

Change From Baseline in Body Weight

End point description

Change from baseline in body weight was reported. LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. APD: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Baseline, Week 78

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	654	330
Units: Kilograms (kg)
least squares mean (standard error)	2.27 ( 0.133 )	2.20 ( 0.186 )

Outcome Measure No. 7

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

984

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.756

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

0.071

Confidence interval

level

95%

sides

2-sided

lower limit

-0.38

upper limit

0.52

Secondary: Percentage of Time in Hypoglycemia Range

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End point title

Percentage of Time in Hypoglycemia Range

End point description

Percentage of time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. APD: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Week 22 to Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	641	325
Units: Percentage of time
least squares mean (standard error)	0.36 ( 0.036 )	0.22 ( 0.051 )

Outcome Measure No. 8

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

966

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.021

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

0.27

Secondary: Percentage of Time in Hyperglycemia Range

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End point title

Percentage of Time in Hyperglycemia Range

End point description

Percentage of time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach. APD: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Week 22 to Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	641	325
Units: Percentage of time
least squares mean (standard error)	37.25 ( 0.700 )	38.24 ( 0.989 )

Outcome Measure No. 9

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

966

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.417

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-0.99

Confidence interval

level

95%

sides

2-sided

lower limit

-3.37

upper limit

1.4

Secondary: Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)

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End point title

Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)

End point description

The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact: - Treatment Burden (6 items) - Daily Life (5 items) - Diabetes Management (5 items) - Compliance (4 items), and - Psychological Health (8 items) Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant’s functioning and well-being. LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

End point type

Secondary

End point timeframe

Baseline, Week 26, Week 52, Week 78 APD: All participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded.

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	625 ^[1]	314 ^[2]
Units: Score on a scale
least squares mean (standard error)
Week 26	10.03 ( 0.424 )	6.88 ( 0.599 )
Week 52	10.09 ( 0.445 )	6.53 ( 0.627 )
Week 78	10.33 ( 0.472 )	6.98 ( 0.662 )

Notes
[1] - For Week 26: n = 625; For Week 52: n = 580; For Week 78: n = 548.
[2] - For Week 26: n = 314; For Week 52: n = 294; For Week 78: n = 281.

Outcome Measure No. 10 - Week 26

Statistical analysis description

For Week 26: LS Mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

939

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

3.15

Confidence interval

level

95%

sides

2-sided

lower limit

1.71

upper limit

4.59

Outcome Measure No. 10 - Week 52

Statistical analysis description

For Week 52: LS Mean was determined by MMRM model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Subjects in this analysis: 874

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

939

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

3.56

Confidence interval

level

95%

sides

2-sided

lower limit

2.05

upper limit

5.07

Outcome Measure No. 10 - Week 78

Statistical analysis description

For Week 78: LS Mean was determined by MMRM model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Subjects in this analysis: 829

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

939

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

3.35

Confidence interval

level

95%

sides

2-sided

lower limit

1.75

upper limit

4.94

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26

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End point title

Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26

End point description

DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. APD: All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	599	304
Units: Score on a scale
arithmetic mean (standard deviation)	14.9 ( 4.47 )	12.3 ( 6.15 )

No statistical analyses for this end point

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52

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End point title

Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	570	290
Units: Score on a scale
arithmetic mean (standard deviation)	15.1 ( 4.45 )	12.3 ( 6.10 )

No statistical analyses for this end point

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78

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End point title

Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78

End point description

End point type

Secondary

End point timeframe

Week 78

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	523	268
Units: Score on a scale
arithmetic mean (standard deviation)	15.4 ( 4.23 )	11.7 ( 6.61 )

No statistical analyses for this end point

Secondary: Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]

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End point title

Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]

End point description

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach. APD: All participants who received at least one dose of study drug and had evaluable data for this outcome at baseline or week 26. Participants who were assigned treatment by mistake were excluded.

End point type

Secondary

End point timeframe

Baseline, Week 26

End point values	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Number of subjects analysed	649	328
Units: Percentage of HbA1c
least squares mean (standard error)	-0.81 ( 0.0302 )	-0.72 ( 0.0424 )

Outcome Measure No. 14

Comparison groups

500 U/mL - Insulin Efsitora v 100 U/mL - Insulin Degludec

Number of subjects included in analysis

977

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.088

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-0.089

Confidence interval

level

95%

sides

2-sided

lower limit

-0.191

upper limit

0.013

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline Through Safety Follow-Up (Up to 83 Weeks)

Adverse event reporting additional description

All participants who received at least one dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.0

Reporting group title

500 U/mL - Insulin Efsitora

Reporting group description

Participants received 500 U/mL insulin efsitora administered SC QW.

Reporting group title

100 U/mL - Insulin Degludec

Reporting group description

Participants received 100 U/mL insulin degludec administered SC QD.

Serious adverse events	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Total subjects affected by serious adverse events
subjects affected / exposed	103 / 655 (15.73%)	37 / 331 (11.18%)
number of deaths (all causes)	7	2
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
angiomyolipoma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
carcinoid tumour pulmonary
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chromophobe renal cell carcinoma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic lymphocytic leukaemia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
colorectal adenocarcinoma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
ductal adenocarcinoma of pancreas
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
endometrial adenocarcinoma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed ^[1]	0 / 279 (0.00%)	1 / 152 (0.66%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric cancer
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastrointestinal stromal tumour
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
malignant melanoma in situ
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastases to meninges
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metastatic gastric cancer
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
prostate cancer
alternative dictionary used: MedDRA 27.0
subjects affected / exposed ^[2]	4 / 376 (1.06%)	0 / 179 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
salivary gland cancer
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
small cell lung cancer metastatic
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
transitional cell carcinoma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
aortic stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
aneurysm thrombosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arterial disorder
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
deep vein thrombosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
extremity necrosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral arterial occlusive disease
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral artery stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
peripheral ischaemia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
shock haemorrhagic
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
coronary revascularisation
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
limb amputation
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
skin graft
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
death
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
chest pain
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
multiple organ dysfunction syndrome
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
sudden death
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
vascular stent stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
benign prostatic hyperplasia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed ^[3]	1 / 376 (0.27%)	0 / 179 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic pain
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
atelectasis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
asthma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchiectasis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cough
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dyspnoea
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
vocal cord polyp
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
continuous glucose monitoring
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
ankle fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
craniofacial fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
fall
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
foot fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
fractured sacrum
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
head injury
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
humerus fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
incorrect dose administered
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ligament rupture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
limb crushing injury
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hip fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pelvic fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
radius fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
rib fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spinal compression fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
wound
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
phimosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed ^[4]	1 / 376 (0.27%)	0 / 179 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
acute myocardial infarction
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	4 / 655 (0.61%)	4 / 331 (1.21%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
acute left ventricular failure
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
arrhythmia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
angina unstable
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	5 / 655 (0.76%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
angina pectoris
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
arteriosclerosis coronary artery
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
atrioventricular block complete
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
atrial flutter
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
atrial fibrillation
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac failure
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	3 / 655 (0.46%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
cardiogenic shock
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
cardio-respiratory arrest
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac valve disease
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cardiac failure chronic
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
chronic coronary syndrome
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery disease
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	4 / 331 (1.21%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
coronary artery stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
left ventricular dysfunction
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
microvascular coronary artery disease
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
ventricular extrasystoles
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
carotid artery stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cerebral infarction
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
cerebrovascular accident
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dural arteriovenous fistula
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
headache
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hemiplegia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypoglycaemic unconsciousness
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ischaemic stroke
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lacunar infarction
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
metabolic encephalopathy
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
myelopathy
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
spondylitic myelopathy
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
thalamus haemorrhage
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
vertigo positional
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
cataract
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	3 / 655 (0.46%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
diabetic retinopathy
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diplopia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
retinal detachment
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
abdominal adhesions
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal pain upper
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
abdominal pain
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
alcoholic pancreatitis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
inguinal hernia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
inguinal hernia, obstructive
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pancreatitis acute
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
acute cholecystitis necrotic
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cholecystitis acute
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
cholelithiasis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
hepatitis acute
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypertransaminasaemia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
diabetic foot
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
calculus bladder
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
bladder neck obstruction
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
haematuria
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
nephrolithiasis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ureteric stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
primary hyperthyroidism
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
arthritis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
back pain
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intervertebral disc protrusion
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
lumbar spinal stenosis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
spinal osteoarthritis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
spondylolisthesis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
abscess limb
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
covid-19 pneumonia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	2 / 655 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
covid-19
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
bronchitis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
cytomegalovirus infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
gangrene
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
gastroenteritis viral
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hcov-oc43 infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hiv infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
localised infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
infective exacerbation of asthma
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
intervertebral discitis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lower respiratory tract infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
perirectal abscess
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
osteomyelitis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	3 / 655 (0.46%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	3 / 655 (0.46%)	4 / 331 (1.21%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
septic shock
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
pneumocystis jirovecii infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	1 / 655 (0.15%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
upper respiratory tract infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
urinary tract infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	0 / 655 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
hypoglycaemia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	4 / 655 (0.61%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	4 / 5	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	500 U/mL - Insulin Efsitora	100 U/mL - Insulin Degludec
Total subjects affected by non serious adverse events
subjects affected / exposed	241 / 655 (36.79%)	102 / 331 (30.82%)
Injury, poisoning and procedural complications
dose calculation error
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	42 / 655 (6.41%)	15 / 331 (4.53%)
occurrences all number	55	18
Nervous system disorders
headache
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	36 / 655 (5.50%)	7 / 331 (2.11%)
occurrences all number	57	9
Gastrointestinal disorders
diarrhoea
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	35 / 655 (5.34%)	14 / 331 (4.23%)
occurrences all number	46	23
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	34 / 655 (5.19%)	12 / 331 (3.63%)
occurrences all number	39	13
back pain
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	33 / 655 (5.04%)	12 / 331 (3.63%)
occurrences all number	35	12
Infections and infestations
covid-19
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	70 / 655 (10.69%)	27 / 331 (8.16%)
occurrences all number	73	28
upper respiratory tract infection
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	34 / 655 (5.19%)	18 / 331 (5.44%)
occurrences all number	40	25
nasopharyngitis
alternative dictionary used: MedDRA 27.0
subjects affected / exposed	60 / 655 (9.16%)	29 / 331 (8.76%)
occurrences all number	88	36

More information

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Were there any global substantial amendments to the protocol? Yes

13 May 2022

- Changes made to address regulatory feedback regarding exclusionary ALT and AST thresholds and include specific details for participants who enter the study and use personal CGM.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently Treated with Basal Insulin (QWINT-3)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]

Primary: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]

Secondary: Nocturnal Hypoglycemia Event Rate

Secondary: Nocturnal Hypoglycemia Event Rate

Secondary: Percentage of Time in Glucose Range

Secondary: Percentage of Time in Glucose Range

Secondary: Change From Baseline in Fasting Glucose

Secondary: Change From Baseline in Fasting Glucose

Secondary: Weekly Insulin Dose at Week 26

Secondary: Weekly Insulin Dose at Week 26

Secondary: Hypoglycemia Event Rate

Secondary: Hypoglycemia Event Rate

Secondary: Change From Baseline in Body Weight

Secondary: Change From Baseline in Body Weight

Secondary: Percentage of Time in Hypoglycemia Range

Secondary: Percentage of Time in Hypoglycemia Range

Secondary: Percentage of Time in Hyperglycemia Range

Secondary: Percentage of Time in Hyperglycemia Range

Secondary: Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)

Secondary: Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78

Secondary: Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78

Secondary: Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]

Secondary: Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently Treated with Basal Insulin (QWINT-3)