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Clinical Trial Results:
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults with Type 1 Diabetes Mellitus

Summary
EudraCT number	2017-003220-78
Trial protocol	DE
Global end of trial date	14 Nov 2019

Results information
Results version number	v1(current)
This version publication date	21 May 2020
First version publication date	21 May 2020
Other versions

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

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Trial information

Top of page

Sponsor protocol code

I8B-MC-ITSA

ISRCTN number

US NCT number

NCT03465878

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16695

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, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

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?

Yes

Analysis stage

Final

Date of interim/final analysis

14 Nov 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Nov 2019

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus. There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Protection of trial subjects

This 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

26 Mar 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 53

Country: Number of subjects enrolled

Germany: 28

Worldwide total number of subjects

EEA total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Participants who completed Part A but discontinued before the beginning of Part B were replaced by newly enrolled participants in Part B.

Screening details

No Text Available

Period 1 title

Period 1

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Sequence 1-Part A

Arm description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog

Arm type

Experimental

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Sequence 2-Part A

Arm description

Participants received either single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014

Arm type

Active comparator

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Sequence 1-Part B

Arm description

Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog

Arm type

Experimental

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Sequence 2-Part B

Arm description

Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014

Arm type

Active comparator

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Number of subjects in period 1	Sequence 1-Part A	Sequence 2-Part A	Sequence 1-Part B	Sequence 2-Part B
Started	21	21	20	19
Received at least 1 dose of study drug	21	21	20	17
Participants Moved From Part A to Part B	0 ^[1]	0 ^[2]	15 ^[3]	10 ^[4]
Children (2-11 Years)	7 ^[5]	6 ^[6]	6 ^[7]	6 ^[8]
Adolescents (12-17 Years)	7 ^[9]	7 ^[10]	7 ^[11]	6 ^[12]
Adults (18-64 Years)	7 ^[13]	8 ^[14]	7 ^[15]	7 ^[16]
Completed	21	20	20	17
Not completed	0	1	0	2
Consent withdrawn by subject	-	1	-	1
Physician decision	-	-	-	1

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.

Period 2 title

Period 2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Sequence 1-Part A

Arm description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog

Arm type

Experimental

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Sequence 2-Part A

Arm description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014

Arm type

Experimental

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Sequence 1-Part B

Arm description

Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog

Arm type

Experimental

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Sequence 2-Part B

Arm description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014

Arm type

Experimental

Investigational medicinal product name

LY900014

Investigational medicinal product code

Other name

Ultra-Rapid Lispro

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods.

Investigational medicinal product name

Humalog

Investigational medicinal product code

Other name

Insulin Lispro; LY275585

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods.

Number of subjects in period 2	Sequence 1-Part A	Sequence 2-Part A	Sequence 1-Part B	Sequence 2-Part B
Started	21	20	20	17
Children (2-11 Years)	7 ^[17]	6 ^[18]	6 ^[19]	6 ^[20]
Adolescents (12-17 Years)	7 ^[21]	7 ^[22]	7 ^[23]	6 ^[24]
Adults (18-64 Years)	7 ^[25]	7 ^[26]	7 ^[27]	5 ^[28]
Completed	21	20	20	17

Notes
[17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[20] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[21] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[22] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[23] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[24] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[25] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[26] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences.
[27] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.
[28] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Milestones were added to show Age group differences and for the participants who moved from Part A to Part B.

Baseline characteristics

Top of page

Reporting group title

Period 1

Reporting group description

Reporting group values	Period 1	Total
Number of subjects	81	81
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	25	25
Adolescents (12-17 years)	27	27
Adults (18-64 years)	29	29
From 65-84 years	0	0
85 years and over	0	0
Gender categorical
Units: Subjects
Female	41	41
Male	40	40
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	2	2
Not Hispanic or Latino	79	79
Unknown or Not Reported	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0
Asian	4	4
Native Hawaiian or Other Pacific Islander	0	0
Black or African American	1	1
White	71	71
More than one race	5	5
Unknown or Not Reported	0	0
Region of Enrollment
Units: Subjects
Canada	53	53
Germany	28	28

Subject analysis set title

Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.

Subject analysis set title

Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of either 100 U/mL LY900014 or Humalog delivered using the CSII pump.

Subject analysis set title

Children-LY900014-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title

Children-Humalog-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title

Adolescents-LY900014-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title

Adolescents-Humalog-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title

Adults-LY900014-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.

Subject analysis set title

Adults-Humalog-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title

Children-LY900014-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title

Children-Humalog-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title

Adolescents-LY900014-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title

Adolescents-Humalog-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title

Adults-LY900014-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title

Adults-Humalog-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Part A

Part B

Children-LY900014-Part A

Children-Humalog-Part A

Adolescents-LY900014-Part A

Adolescents-Humalog-Part A

Adults-LY900014-Part A

Adults-Humalog-Part A

Children-LY900014-Part B

Children-Humalog-Part B

Adolescents-LY900014-Part B

Adolescents-Humalog-Part B

Adults-LY900014-Part B

Adults-Humalog-Part B

Number of subjects

Units: Subjects

In utero

Preterm newborn infants (gestational age < 37 wks)

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65-84 years

85 years and over

Units: years

arithmetic mean (standard deviation)

Units: Subjects

Female

Male

Units: Subjects

Hispanic or Latino

Not Hispanic or Latino

Unknown or Not Reported

Units: Subjects

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Units: Subjects

Canada

Germany

End points

Top of page

Reporting group title

Sequence 1-Part A

Reporting group description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog

Reporting group title

Sequence 2-Part A

Reporting group description

Participants received either single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014

Reporting group title

Sequence 1-Part B

Reporting group description

Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog

Reporting group title

Sequence 2-Part B

Reporting group description

Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014

Reporting group title

Sequence 1-Part A

Reporting group description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: LY900014 Period 2: Humalog

Reporting group title

Sequence 2-Part A

Reporting group description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014 or Humalog. Period 1: Humalog Period 2: LY900014

Reporting group title

Sequence 1-Part B

Reporting group description

Participants received either single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 or Humalog delivered using the CSII pump. Period 1: LY900014 Period 2: Humalog

Reporting group title

Sequence 2-Part B

Reporting group description

Participants received either single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of 100 U/mL LY900014 or Humalog with delivered using the CSII pump. Period 1: Humalog Period 2: LY900014

Subject analysis set title

Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014 or Humalog.

Subject analysis set title

Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus infusion of either 100 U/mL LY900014 or Humalog delivered using the CSII pump.

Subject analysis set title

Children-LY900014-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title

Children-Humalog-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title

Adolescents-LY900014-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL LY900014.

Subject analysis set title

Adolescents-Humalog-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title

Adults-LY900014-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100U/mL LY900014.

Subject analysis set title

Adults-Humalog-Part A

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL Humalog.

Subject analysis set title

Children-LY900014-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title

Children-Humalog-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title

Adolescents-LY900014-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title

Adolescents-Humalog-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Subject analysis set title

Adults-LY900014-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the CSII pump.

Subject analysis set title

Adults-Humalog-Part B

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

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End point title

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

End point description

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data.

End point type

Primary

End point timeframe

Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose

Children-LY900014-Part A

Children-Humalog-Part A

Adolescents-LY900014-Part A

Adolescents-Humalog-Part A

Adults-LY900014-Part A

Adults-Humalog-Part A

Children-LY900014-Part B

Children-Humalog-Part B

Adolescents-LY900014-Part B

Adolescents-Humalog-Part B

Adults-LY900014-Part B

Adults-Humalog-Part B

Number of subjects analysed

Units: picomols * hour per Liter

geometric mean (geometric coefficient of variation)

755 ± 15

754 ± 17

962 ± 17

908 ± 21

987 ± 20

975 ± 21

743 ± 17

714 ± 17

842 ± 20

866 ± 16

1100 ± 35

1070 ± 35

AUC(0 -7h)

Comparison groups

Children-LY900014-Part A v Children-Humalog-Part A

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9813

Method

Mixed models analysis

Parameter type

Ratio of geometric least squares means

Point estimate

0.999

Confidence interval

level

95%

sides

2-sided

lower limit

0.918

upper limit

1.09

AUC(0 -7h)

Comparison groups

Adolescents-LY900014-Part A v Adolescents-Humalog-Part A

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1638

Method

Mixed models analysis

Parameter type

Ratio of geometric least squares means

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.976

upper limit

1.15

AUC(0 -7h)

Comparison groups

Adults-LY900014-Part A v Adults-Humalog-Part A

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7623

Method

Mixed models analysis

Parameter type

Ratio of geometric least squares means

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

0.933

upper limit

1.1

AUC(0 -7h)

Comparison groups

Children-LY900014-Part B v Children-Humalog-Part B

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2952

Method

Mixed models analysis

Parameter type

Ratio of geometric least squares means

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.962

upper limit

1.13

AUC(0 -7h)

Comparison groups

Adolescents-LY900014-Part B v Adolescents-Humalog-Part B

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4052

Method

Mixed models analysis

Parameter type

Ratio of geometric least squares means

Point estimate

0.97

Confidence interval

level

95%

sides

2-sided

lower limit

0.901

upper limit

1.04

AUC(0 -7h)

Comparison groups

Adults-LY900014-Part B v Adults-Humalog-Part B

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5314

Method

Mixed models analysis

Parameter type

Ratio of geometric least squares means

Point estimate

1.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.948

upper limit

1.11

Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

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End point title

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

End point description

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable Glucodynamics data.

End point type

Secondary

End point timeframe

-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose

Children-LY900014-Part A

Children-Humalog-Part A

Adolescents-LY900014-Part A

Adolescents-Humalog-Part A

Adults-LY900014-Part A

Adults-Humalog-Part A

Children-LY900014-Part B

Children-Humalog-Part B

Adolescents-LY900014-Part B

Adolescents-Humalog-Part B

Adults-LY900014-Part B

Adults-Humalog-Part B

Number of subjects analysed

Units: milligrams * hour per deciliter

arithmetic mean (standard deviation)

384 ± 335

492 ± 270

577 ± 247

651 ± 238

372 ± 179

351 ± 240

602 ± 221

582 ± 254

614 ± 160

614 ± 163

343 ± 194

401 ± 235

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

I8B-MC-ITSA

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Children-LY900014-Part A

Reporting group description

Reporting group title

Children-Humalog-Part A

Reporting group description

Reporting group title

Adolescents-LY900014-Part A

Reporting group description

Reporting group title

Adolescents-Humalog-Part A

Reporting group description

Reporting group title

Adults-LY900014-Part A

Reporting group description

Reporting group title

Adults-Humalog-Part A

Reporting group description

Reporting group title

Children-LY900014-Part B

Reporting group description

Reporting group title

Children-Humalog-Part B

Reporting group description

Reporting group title

Adolescents-LY900014-Part B

Reporting group description

Reporting group title

Adolescents-Humalog-Part B

Reporting group description

Reporting group title

Adults-LY900014-Part B

Reporting group description

Reporting group title

Adults-Humalog-Part B

Reporting group description

Children-LY900014-Part A

Children-Humalog-Part A

Adolescents-LY900014-Part A

Adolescents-Humalog-Part A

Adults-LY900014-Part A

Adults-Humalog-Part A

Children-LY900014-Part B

Children-Humalog-Part B

Adolescents-LY900014-Part B

Adolescents-Humalog-Part B

Adults-LY900014-Part B

Adults-Humalog-Part B

Total subjects affected by serious adverse events

subjects affected / exposed

0 / 13 (0.00%)

1 / 14 (7.14%)

0 / 14 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 13 (0.00%)

0 / 12 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Injury, poisoning and procedural complications

injury

alternative dictionary used: MedDRA 21.1

subjects affected / exposed

0 / 13 (0.00%)

1 / 14 (7.14%)

0 / 14 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 13 (0.00%)

0 / 12 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Children-LY900014-Part A	Children-Humalog-Part A	Adolescents-LY900014-Part A	Adolescents-Humalog-Part A	Adults-LY900014-Part A	Adults-Humalog-Part A	Children-LY900014-Part B	Children-Humalog-Part B	Adolescents-LY900014-Part B	Adolescents-Humalog-Part B	Adults-LY900014-Part B	Adults-Humalog-Part B
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 13 (30.77%)	4 / 13 (30.77%)	6 / 14 (42.86%)	3 / 14 (21.43%)	2 / 14 (14.29%)	2 / 15 (13.33%)	6 / 12 (50.00%)	4 / 12 (33.33%)	3 / 13 (23.08%)	1 / 13 (7.69%)	3 / 12 (25.00%)	2 / 12 (16.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lipoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
feeling hot
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
injection site discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
injection site erythema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 13 (15.38%)	0 / 13 (0.00%)	2 / 14 (14.29%)	1 / 14 (7.14%)	1 / 14 (7.14%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	2	0	2	1	1	0	0	0	0	0	1	0
injection site pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 13 (7.69%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 13 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	1	0	0	1	0	0	1	0	1	0	1	1
injection site pruritus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Immune system disorders
seasonal allergy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0	0
Reproductive system and breast disorders
dysmenorrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0
ovarian cyst ruptured
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
epistaxis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
procedural pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 13 (7.69%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
headache
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0
nausea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 13 (7.69%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	1 / 14 (7.14%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0	0	0	0	0
vomiting
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	1 / 14 (7.14%)	1 / 14 (7.14%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
lipohypertrophy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	1 / 13 (7.69%)	1 / 14 (7.14%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 13 (7.69%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	1	1	0	0	1	0	1	0	0	0
Renal and urinary disorders
leukocyturia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Endocrine disorders
hypothyroidism
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Infections and infestations
acne pustular
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
cystitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
ear infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0
gastroenteritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
groin abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
nasopharyngitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 13 (7.69%)	2 / 13 (15.38%)	1 / 14 (7.14%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	2	1	0	0	0	0	0	0	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0
Metabolism and nutrition disorders
hyperglycaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 13 (7.69%)	1 / 13 (7.69%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 14 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 13 (0.00%)	0 / 13 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1	0	0	0	0	1	1	0	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

19 Mar 2018

Protocol (b): Total daily insulin dose was updated in inclusion criteria.

17 Apr 2018

Protocol (c): Inpatient Procedures for Part A and B was updated.

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 Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults with Type 1 Diabetes Mellitus

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
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Croatia
Cyprus
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Estonia
Finland
France
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Greece
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Ireland
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Netherlands
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Poland
Portugal
Romania
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Slovenia
Spain
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United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults with Type 1 Diabetes Mellitus

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) following Each Treatment Arm for Each Study Part

Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

Secondary: Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults with Type 1 Diabetes Mellitus