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Clinical Trial Results:
A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

Summary
EudraCT number	2013-003625-29
Trial protocol	HU SE CZ NL DE ES
Global end of trial date	12 Dec 2014

Results information
Results version number	v1(current)
This version publication date	02 Nov 2016
First version publication date	02 Nov 2016
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

HM-EXC-203

ISRCTN number

US NCT number

NCT02057172

WHO universal trial number (UTN)

Sponsor organisation name

Hanmi Pharmaceutical Co., Ltd.

Sponsor organisation address

14, Wiryeseong-daero, Songpa-gu, Seoul, Korea, Republic of, 05545

Public contact

Jahoon Kang, Executive Director of Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd., +82 2-410-9041, jhkang@hanmi.co.kr

Scientific contact

Jahoon Kang, Executive Director of Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd., +82 2-410-9041, jhkang@hanmi.co.kr

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 Apr 2015

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

12 Dec 2014

Was the trial ended prematurely?

Main objective of the trial

To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed by HbA1c in subjects with T2DM

Protection of trial subjects

Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with ICH GCP ensuring that those involved with the conduct of the study abides by the laws governing personal data protection in force in all countries in which it operates.

Background therapy

Evidence for comparator

Actual start date of recruitment

30 Dec 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 24

Country: Number of subjects enrolled

Sweden: 9

Country: Number of subjects enrolled

Czech Republic: 13

Country: Number of subjects enrolled

Germany: 20

Country: Number of subjects enrolled

Hungary: 22

Country: Number of subjects enrolled

United States: 163

Country: Number of subjects enrolled

Korea, Republic of: 3

Worldwide total number of subjects

254

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)

211

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Recruitment period from 30-Dec-13 (First patient In) to 14-Jul-14 (Last Patient In)- regions USA, Europe (Czech Republic, Germany, Hungary, Spain and Sweden) and Asia (South Korea)

Screening details

593 subjects were screened for inclusion in this study. Screening period was a 4-week period. The screening visits (Visits 1A and 1B) took place between study days -28 and -5. Eligible subjects who met all of the inclusion criteria and none of the exclusion criteria returned to the clinic on Day 1 for baseline , randomisation, and study drug use.

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst

Blinding implementation details

HM11260C and placebo for HM11260C were provided in identically matched pre-filled syringe and packaged identically. Liraglutide was provided in open label.

Are arms mutually exclusive

Yes

HM11260C (0.3 mg)

Arm description

subcutaneous (sc) HM11260C 0.3 mg once a week (QW) for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Long-acting CA Exendin-4-HMC001 conjugate

Investigational medicinal product code

HM11260C

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.4 ml of HM11260C was self administered by subcutaneous injection in the morning within 60 minutes before the meal using pre-filled syringe.

HM11260C (1 mg)

Arm description

subcutaneous (sc) HM11260C 1 mg once a week (QW) for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Long-acting CA Exendin-4-HMC001 conjugate

Investigational medicinal product code

HM11260C

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.4 ml of HM11260C was self administered by subcutaneous injection in the morning within 60 minutes before the meal using pre-filled syringe.

HM11260C (2 mg)

Arm description

subcutaneous (sc) HM11260C 2 mg once a week (QW) for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Long-acting CA Exendin-4-HMC001 conjugate

Investigational medicinal product code

HM11260C

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.4 ml of HM11260C was self administered by subcutaneous injection in the morning within 60 minutes before the meal using pre-filled syringe.

HM11260C (3 mg)

Arm description

subcutaneous (sc) HM11260C 3 mg once a week (QW) for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Long-acting CA Exendin-4-HMC001 conjugate

Investigational medicinal product code

HM11260C

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.4 ml of HM11260C was self administered by subcutaneous injection in the morning within 60 minutes before the meal using pre-filled syringe.

HM11260C (4 mg)

Arm description

subcutaneous (sc) HM11260C 4 mg once a week (QW) for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Long-acting CA Exendin-4-HMC001 conjugate

Investigational medicinal product code

HM11260C

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.4 ml of HM11260C was self administered by subcutaneous injection in the morning within 60 minutes before the meal using pre-filled syringe

Placebo

Arm description

subcutaneous (sc) Placebo identical to HM11260C once a week (QW) for 12 weeks

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

0.4 ml of Placebo was self administered by subcutaneous injection in the morning within 60 minutes before the meal using pre-filled syringe.

Liraglutide

Arm description

open label, daily injection, with titration as per label

Arm type

Active comparator

Investigational medicinal product name

Liraglutide

Investigational medicinal product code

Other name

Victoza®

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Formulation and Administration: Liraglutide will be dispensed in a prefilled, multidose pen that delivers 0.6 mg, 1.2 mg, or 1.8 mg. It will be administered subcutaneously in the abdomen, thigh or upper arm in accordance with the Victoza package insert. Frequency: Liraglutide was administered daily at doses of 0.6 mg on Days 1 to 7, 1.2 mg on Days 8 to 14 and 1.8 mg on Days 15 to 84. It is a forced titration.

Number of subjects in period 1 ^[1]	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Started	37	37	33	36	36	37	36
Completed	33	34	27	29	27	33	28
Not completed	4	3	6	7	9	4	8
Adverse event, non-fatal	-	-	2	3	1	-	4
Prohibited treatment	-	-	-	-	1	-	-
Other	1	-	-	-	-	-	-
Lost to follow-up	2	2	2	1	1	3	1
Withdrawal by subject	1	1	2	2	4	1	3
Protocol deviation	-	-	-	1	1	-	-
Noncompliance	-	-	-	-	1	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 254 subjects were randomised in the study. Of these, 181 subjects were randomised to HM11260C, 37 to placebo and 36 to liraglutide. 252 subjects received study drug (HM11260C, placebo or liraglutide) and were included in the Safety Set.

Baseline characteristics

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Reporting group title

HM11260C (0.3 mg)

Reporting group description

subcutaneous (sc) HM11260C 0.3 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (1 mg)

Reporting group description

subcutaneous (sc) HM11260C 1 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (2 mg)

Reporting group description

subcutaneous (sc) HM11260C 2 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (3 mg)

Reporting group description

subcutaneous (sc) HM11260C 3 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (4 mg)

Reporting group description

subcutaneous (sc) HM11260C 4 mg once a week (QW) for 12 weeks

Reporting group title

Placebo

Reporting group description

subcutaneous (sc) Placebo identical to HM11260C once a week (QW) for 12 weeks

Reporting group title

Liraglutide

Reporting group description

open label, daily injection, with titration as per label

Reporting group values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide	Total
Number of subjects	37	37	33	36	36	37	36	252
Age categorical
Units: Subjects
Age continuous
Collection method or subject population
Units: years
arithmetic mean (standard deviation)	56.2 ± 10.89	55.1 ± 8.81	55.8 ± 10.19	54.1 ± 9.89	56.3 ± 9.67	55.4 ± 9.29	53.9 ± 10.77	-
Gender categorical
Units: Subjects
Female	13	18	15	13	18	21	20	118
Male	24	19	18	23	18	16	16	134

End points

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Reporting group title

HM11260C (0.3 mg)

Reporting group description

subcutaneous (sc) HM11260C 0.3 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (1 mg)

Reporting group description

subcutaneous (sc) HM11260C 1 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (2 mg)

Reporting group description

subcutaneous (sc) HM11260C 2 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (3 mg)

Reporting group description

subcutaneous (sc) HM11260C 3 mg once a week (QW) for 12 weeks

Reporting group title

HM11260C (4 mg)

Reporting group description

subcutaneous (sc) HM11260C 4 mg once a week (QW) for 12 weeks

Reporting group title

Placebo

Reporting group description

subcutaneous (sc) Placebo identical to HM11260C once a week (QW) for 12 weeks

Reporting group title

Liraglutide

Reporting group description

open label, daily injection, with titration as per label

Primary: Change from Baseline in HbA1c

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End point title

Change from Baseline in HbA1c

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Primary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: Percentage of Hemoglobin
least squares mean (standard error)	-0.56 ± 0.114	-0.95 ± 0.111	-1.19 ± 0.121	-1.41 ± 0.119	-1.61 ± 0.118	-0.4 ± 0.111	-1.38 ± 0.12

Change from baseline in HbA1c for 0.3mg vs placebo

Statistical analysis description

Full Analysis Set

Comparison groups

HM11260C (0.3 mg) v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.3029

Method

Mixed Model Repeated Measures

Parameter type

LS Mean Difference

Point estimate

-0.16

Confidence interval

level

95.1%

sides

2-sided

lower limit

-0.47

upper limit

0.15

Variability estimate

Standard error of the mean

Notes
[1] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

Change from baseline in HbA1c for 1 mg vs placebo

Statistical analysis description

Full Analysis Set

Comparison groups

HM11260C (1 mg) v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.0005

Method

Mixed Model Repeated Measures

Parameter type

LS Mean Difference

Point estimate

-0.55

Confidence interval

level

95.1%

sides

2-sided

lower limit

-0.86

upper limit

-0.24

Variability estimate

Standard error of the mean

Notes
[2] - The threshold for significance is a p-value <= 0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

Change from baseline in HbA1c for 2 mg vs. placebo

Statistical analysis description

Full Analysis Set

Comparison groups

HM11260C (2 mg) v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

< 0.0001

Method

Mixed Model Repeated Measures

Parameter type

LS Mean Difference

Point estimate

-0.79

Confidence interval

level

95.1%

sides

2-sided

lower limit

-1.11

upper limit

-0.47

Variability estimate

Standard error of the mean

Notes
[3] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

Change from baseline in HbA1c for 3 mg vs. placebo

Statistical analysis description

Full Analysis Set

Comparison groups

HM11260C (3 mg) v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

P-value

< 0.0001

Method

Mixed Model Repeated Measures

Parameter type

LS Mean Difference

Point estimate

-1.01

Confidence interval

level

95.1%

sides

2-sided

lower limit

-1.33

upper limit

-0.69

Variability estimate

Standard error of the mean

Notes
[4] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

Change from baseline in HbA1c for 4 mg vs. placebo

Statistical analysis description

Full Analysis Set

Comparison groups

HM11260C (4 mg) v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

< 0.0001

Method

Mixed Model Repeated Measures

Parameter type

LS Mean Difference

Point estimate

-1.21

Confidence interval

level

95.1%

sides

2-sided

lower limit

-1.53

upper limit

-0.89

Variability estimate

Standard error of the mean

Notes
[5] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

Secondary: Subjects who had a HbA1c level of < 7%

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End point title

Subjects who had a HbA1c level of < 7%

End point description

Percentage of subjects with HbA1c < 7% by visit, treatment group, and metformin.

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: Percentage of Subjects
number (not applicable)	32.4	64.9	60.6	72.2	69.4	24.3	61.1

No statistical analyses for this end point

Secondary: Change from Baseline in Fasting Plasma Glucose

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End point title

Change from Baseline in Fasting Plasma Glucose

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: mmol/L
least squares mean (standard error)	-0.61 ± 0.293	-1.35 ± 0.28	-1.31 ± 0.304	-2.25 ± 0.303	-2.5 ± 0.3	-0.55 ± 0.281	-1.51 ± 0.304

No statistical analyses for this end point

Secondary: Change from baseline in body weight

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End point title

Change from baseline in body weight

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: kg
least squares mean (standard error)	-1.209 ± 0.526	-2.014 ± 0.508	-1.522 ± 0.553	-2.732 ± 0.55	-3.309 ± 0.543	-1.29 ± 0.511	-3.212 ± 0.558

No statistical analyses for this end point

Secondary: Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

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End point title

Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: mmol/L
least squares mean (standard error)	-0.637 ± 0.274	-1.519 ± 0.257	-2.008 ± 0.295	-2.348 ± 0.288	-2.628 ± 0.295	-0.582 ± 0.267	-2.107 ± 0.286

No statistical analyses for this end point

Secondary: Change from Baseline in Other diabetes-related parameters (fasting insulin)

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End point title

Change from Baseline in Other diabetes-related parameters (fasting insulin)

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: pmol/L
least squares mean (standard error)	10.72 ± 21.534	3.07 ± 21.014	25.37 ± 22.428	2.66 ± 22.626	13.32 ± 23.704	4.33 ± 21.384	60.23 ± 22.333

No statistical analyses for this end point

Secondary: Change from Baseline in Other diabetes-related parameters (C-Peptide)

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End point title

Change from Baseline in Other diabetes-related parameters (C-Peptide)

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: nmol/L
least squares mean (standard error)	0.013 ± 0.034	-0.046 ± 0.032	0.009 ± 0.035	0.027 ± 0.035	0.008 ± 0.036	0.027 ± 0.033	0.043 ± 0.035

No statistical analyses for this end point

Secondary: Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

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End point title

Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: percent
least squares mean (standard error)	-0.13 ± 0.043	-0.29 ± 0.04	-0.35 ± 0.044	-0.42 ± 0.043	-0.45 ± 0.044	-0.13 ± 0.041	-0.36 ± 0.044

No statistical analyses for this end point

Secondary: Change from Baseline in Serum Lipid Profile (Parameters LDL-C, HDL-C, TG)

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End point title

Change from Baseline in Serum Lipid Profile (Parameters LDL-C, HDL-C, TG)

End point description

Least squares (LS) means and standard errors at Week 13 were obtained from a mixed effect model with repeated measures (MMRM).

End point type

Secondary

End point timeframe

Week 13

End point values	HM11260C (0.3 mg)	HM11260C (1 mg)	HM11260C (2 mg)	HM11260C (3 mg)	HM11260C (4 mg)	Placebo	Liraglutide
Number of subjects analysed	37	37	33	36	36	37	36
Units: mmol/L
least squares mean (standard error)
Parameter LDL-C	-0.09 ± 0.091	0.11 ± 0.089	-0.09 ± 0.094	-0.06 ± 0.096	-0.22 ± 0.095	0.09 ± 0.088	-0.16 ± 0.096
Parameter HDL-C	0 ± 0.027	0.05 ± 0.026	0.02 ± 0.028	-0.02 ± 0.028	-0.01 ± 0.028	0.02 ± 0.026	0.01 ± 0.029
Parameter TG	-0.016 ± 0.137	-0.27 ± 0.135	-0.305 ± 0.143	-0.414 ± 0.146	-0.592 ± 0.145	-0.093 ± 0.133	-0.154 ± 0.145

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs were collected beginning at screening and continuing through the final patient visit. SAEs, regardless of suspected causality, were recorded until at least 30 days after the subject had stopped study participation.

Adverse event reporting additional description

Reported AEs were TEAEs that had a start date on or after the first dose of IP or, if the start date was before the date of the first dose of IP, increased in severity on or after the date of the first dose of IP. Treatment-emergent SAEs and TEAEs were reported for the Safety Set, consisting of all participants who received any study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

HM11260C (0.3mg)

Reporting group description

Subjects received HM11260C 0.3mg every 7 days as a subcutaneous injection in the abdomen via a pre-filled syringe.

Reporting group title

HM11260C (1mg)

Reporting group description

Subjects received HM11260C 1mg every 7 days as a subcutaneous injection in the abdomen via a pre-filled syringe.

Reporting group title

HM11260C (2mg)

Reporting group description

Subjects received HM11260C 2mg every 7 days as a subcutaneous injection in the abdomen via a pre-filled syringe

Reporting group title

HM11260C (3mg)

Reporting group description

Subjects received HM11260C 3mg every 7 days as a subcutaneous injection in the abdomen via a pre-filled syringe.

Reporting group title

HM11260C (4mg)

Reporting group description

Subjects received HM11260C 4mg every 7 days as a subcutaneous injection in the abdomen via a pre-filled syringe.

Reporting group title

Placebo

Reporting group description

Subjects received matching placebo every 7 days as a subcutaneous injection in the abdomen via a pre-filled syringe.

Reporting group title

Liraglutide

Reporting group description

Subjects received liraglutide daily according to the package label via pre-filled, multi-dose pen.

Serious adverse events	HM11260C (0.3mg)	HM11260C (1mg)	HM11260C (2mg)	HM11260C (3mg)	HM11260C (4mg)	Placebo	Liraglutide
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 33 (3.03%)	2 / 36 (5.56%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0
General disorders and administration site conditions
Device failure
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 33 (3.03%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	HM11260C (0.3mg)	HM11260C (1mg)	HM11260C (2mg)	HM11260C (3mg)	HM11260C (4mg)	Placebo	Liraglutide
Total subjects affected by non serious adverse events
subjects affected / exposed	19 / 37 (51.35%)	26 / 37 (70.27%)	25 / 33 (75.76%)	24 / 36 (66.67%)	24 / 36 (66.67%)	23 / 37 (62.16%)	29 / 36 (80.56%)
Investigations
Lipase increased
subjects affected / exposed	0 / 37 (0.00%)	5 / 37 (13.51%)	1 / 33 (3.03%)	4 / 36 (11.11%)	1 / 36 (2.78%)	1 / 37 (2.70%)	2 / 36 (5.56%)
occurrences all number	0	5	2	4	1	1	2
Nervous system disorders
Headache
subjects affected / exposed	2 / 37 (5.41%)	4 / 37 (10.81%)	3 / 33 (9.09%)	3 / 36 (8.33%)	4 / 36 (11.11%)	5 / 37 (13.51%)	3 / 36 (8.33%)
occurrences all number	2	4	5	3	5	6	3
Dizziness
subjects affected / exposed	1 / 37 (2.70%)	2 / 37 (5.41%)	1 / 33 (3.03%)	0 / 36 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)	1 / 36 (2.78%)
occurrences all number	1	2	1	0	3	0	2
General disorders and administration site conditions
Injection site bruising
subjects affected / exposed	2 / 37 (5.41%)	1 / 37 (2.70%)	2 / 33 (6.06%)	4 / 36 (11.11%)	0 / 36 (0.00%)	3 / 37 (8.11%)	7 / 36 (19.44%)
occurrences all number	7	1	2	6	0	4	14
Injection site pain
subjects affected / exposed	2 / 37 (5.41%)	2 / 37 (5.41%)	1 / 33 (3.03%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	3 / 36 (8.33%)
occurrences all number	3	3	1	0	0	1	6
Oedema peripheral
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	2 / 36 (5.56%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	0	0	2	0	0	1
Pyrexia
subjects affected / exposed	0 / 37 (0.00%)	2 / 37 (5.41%)	1 / 33 (3.03%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	0	2	1	0	0	0	0
Gastrointestinal disorders
Nausea
subjects affected / exposed	4 / 37 (10.81%)	3 / 37 (8.11%)	9 / 33 (27.27%)	8 / 36 (22.22%)	12 / 36 (33.33%)	6 / 37 (16.22%)	12 / 36 (33.33%)
occurrences all number	5	4	10	10	23	6	15
Diarrhoea
subjects affected / exposed	5 / 37 (13.51%)	1 / 37 (2.70%)	3 / 33 (9.09%)	4 / 36 (11.11%)	2 / 36 (5.56%)	2 / 37 (5.41%)	5 / 36 (13.89%)
occurrences all number	5	1	3	5	7	2	6
Vomiting
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	4 / 33 (12.12%)	4 / 36 (11.11%)	8 / 36 (22.22%)	0 / 37 (0.00%)	4 / 36 (11.11%)
occurrences all number	0	2	4	5	14	0	4
Abdominal pain upper
subjects affected / exposed	1 / 37 (2.70%)	2 / 37 (5.41%)	0 / 33 (0.00%)	1 / 36 (2.78%)	2 / 36 (5.56%)	0 / 37 (0.00%)	1 / 36 (2.78%)
occurrences all number	1	2	0	1	2	0	1
Constipation
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	5 / 36 (13.89%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	0	0	5	0	0	1
Abdominal discomfort
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	2 / 36 (5.56%)	2 / 36 (5.56%)	0 / 37 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	0	0	2	2	0	1
Dyspepsia
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 33 (0.00%)	1 / 36 (2.78%)	2 / 36 (5.56%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	0	1	0	3	2	0	0
Abdominal distension
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	2 / 36 (5.56%)
occurrences all number	1	0	0	0	0	0	2
Eructation
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)	2 / 36 (5.56%)
occurrences all number	0	0	0	1	0	0	2
Gastritis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)	2 / 36 (5.56%)
occurrences all number	0	0	0	1	0	0	2
Hepatobiliary disorders
Hepatomegaly
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)	0 / 36 (0.00%)
occurrences all number	0	0	0	0	0	2	0
Skin and subcutaneous tissue disorders
Hyperhidrosis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 36 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	0	0	0	0	2	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	3 / 37 (8.11%)	2 / 37 (5.41%)	1 / 33 (3.03%)	1 / 36 (2.78%)	1 / 36 (2.78%)	1 / 37 (2.70%)	0 / 36 (0.00%)
occurrences all number	3	2	1	1	1	1	0
Urinary tract infection
subjects affected / exposed	2 / 37 (5.41%)	2 / 37 (5.41%)	0 / 33 (0.00%)	2 / 36 (5.56%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	2	2	0	2	1	0	0
Upper respiratory tract infection
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 33 (0.00%)	2 / 36 (5.56%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	1	0	0	2	1	0	0
Sinusitis
subjects affected / exposed	0 / 37 (0.00%)	2 / 37 (5.41%)	0 / 33 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	0	2	0	1	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 36 (2.78%)	2 / 36 (5.56%)	0 / 37 (0.00%)	3 / 36 (8.33%)
occurrences all number	0	0	0	1	2	0	3
Hypercholesterolaemia
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 36 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)	0 / 36 (0.00%)
occurrences all number	0	0	0	0	2	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

25 Sep 2013

Version 1.1 Global protocol amendment of protocol Version 01 to clarify about PK assessment, IWRS, and drug accountability procedures and so on.

10 Apr 2014

Version 2.0 Global protocol amendment (excluding Germany) developed from and replacing protocol Version 1.1: the amendment was issued primarily to update the contraception inclusion criterion and modify other criteria.

29 May 2014

Version 3.0 Global protocol amendment (excluding Germany) of protocol Version 2.0: the amendment was issued further to the decision when to conduct the interim analysis.

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.

Per Global Protocol AM#3, v.4.0, 17-Dec-14 Glucagon assay performed as part of the "other-diabetes-related parameters" was not sensitive enough and did not provide results within the normal range for glucagon. It was removed as an efficacy assessment

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Clinical trials

Clinical Trial Results:
A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in HbA1c

Primary: Change from Baseline in HbA1c

Secondary: Subjects who had a HbA1c level of < 7%

Secondary: Subjects who had a HbA1c level of < 7%

Secondary: Change from Baseline in Fasting Plasma Glucose

Secondary: Change from Baseline in Fasting Plasma Glucose

Secondary: Change from baseline in body weight

Secondary: Change from baseline in body weight

Secondary: Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

Secondary: Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

Secondary: Change from Baseline in Other diabetes-related parameters (fasting insulin)

Secondary: Change from Baseline in Other diabetes-related parameters (fasting insulin)

Secondary: Change from Baseline in Other diabetes-related parameters (C-Peptide)

Secondary: Change from Baseline in Other diabetes-related parameters (C-Peptide)

Secondary: Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

Secondary: Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

Secondary: Change from Baseline in Serum Lipid Profile (Parameters LDL-C, HDL-C, TG)

Secondary: Change from Baseline in Serum Lipid Profile (Parameters LDL-C, HDL-C, TG)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Italy
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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in HbA1c

Primary: Change from Baseline in HbA1c

Secondary: Subjects who had a HbA1c level of < 7%

Secondary: Subjects who had a HbA1c level of < 7%

Secondary: Change from Baseline in Fasting Plasma Glucose

Secondary: Change from Baseline in Fasting Plasma Glucose

Secondary: Change from baseline in body weight

Secondary: Change from baseline in body weight

Secondary: Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

Secondary: Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

Secondary: Change from Baseline in Other diabetes-related parameters (fasting insulin)

Secondary: Change from Baseline in Other diabetes-related parameters (fasting insulin)

Secondary: Change from Baseline in Other diabetes-related parameters (C-Peptide)

Secondary: Change from Baseline in Other diabetes-related parameters (C-Peptide)

Secondary: Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

Secondary: Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

Secondary: Change from Baseline in Serum Lipid Profile (Parameters LDL-C, HDL-C, TG)

Secondary: Change from Baseline in Serum Lipid Profile (Parameters LDL-C, HDL-C, TG)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes