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Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liraglutide
placebo
liraglutide
liraglutide
glimepiride
metformin
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
  • HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
  • HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
  • BMI less than 45.0 kg/m^2

Exclusion Criteria:

  • Treatment with insulin within the last 3 months prior to the trial
  • Impaired liver or/and renal function
  • Significant cardiovascular disease over the last 6 months
  • Known retinopathy or maculopathy
  • Recurrent major hypoglycaemia or hypoglycaemic unawareness

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Lira 0.6 + Met

Lira 1.2 + Met

Lira 1.8 + Met

Glim + Met

Arm Description

Liraglutide 0.6 mg + metformin + glimepiride placebo

Liraglutide 1.2 mg + metformin + glimepiride placebo

Liraglutide + metformin + glimepiride placebo

Glimepiride 4.0 mg + metformin + liraglutide placebo

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin A1c (HbA1c)
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).

Secondary Outcome Measures

Change in Body Weight
Change in body weight from baseline (week 0) to 16 weeks (end of treatment)
Change in Self-measured Fasting Plasma Glucose
Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.
7-point Self-measured Plasma Glucose Profiles
Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).
Change in Beta-cell Function
Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
Change in Fasting Lipid Profile
Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on: Total Cholesterol (TC) Low-density Lipoprotein-cholesterol (LDL-C) Very Low-density Lipoprotein-cholesterol (VLDL-C) High-density Lipoprotein-cholesterol (HDL-C) Triglyceride (TG) Free Fatty Acid (FFA)
Change in Fasting Lipid Profile, APO-B
Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Full Information

First Posted
January 15, 2008
Last Updated
January 25, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00614120
Brief Title
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Official Title
Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
929 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lira 0.6 + Met
Arm Type
Experimental
Arm Description
Liraglutide 0.6 mg + metformin + glimepiride placebo
Arm Title
Lira 1.2 + Met
Arm Type
Experimental
Arm Description
Liraglutide 1.2 mg + metformin + glimepiride placebo
Arm Title
Lira 1.8 + Met
Arm Type
Experimental
Arm Description
Liraglutide + metformin + glimepiride placebo
Arm Title
Glim + Met
Arm Type
Experimental
Arm Description
Glimepiride 4.0 mg + metformin + liraglutide placebo
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
0.6 mg/day, s.c. (under the skin) injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Glimepiride placebo, capsules
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
1.2 mg/day, s.c. (under the skin) injection
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
1.8 mg/day, s.c. (under the skin) injection
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
Capsules, 4.0 mg/day
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Tablets, 1.5-2.0 g/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Liraglutide placebo, s.c. (under the skin) injection
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin A1c (HbA1c)
Description
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).
Time Frame
week 0, week 16
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
Change in body weight from baseline (week 0) to 16 weeks (end of treatment)
Time Frame
week 0, week 16
Title
Change in Self-measured Fasting Plasma Glucose
Description
Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.
Time Frame
week 0, week 16
Title
7-point Self-measured Plasma Glucose Profiles
Description
Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).
Time Frame
week 0, 8, 12 and 16
Title
Change in Beta-cell Function
Description
Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
Time Frame
week 0, week 16
Title
Change in Fasting Lipid Profile
Description
Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on: Total Cholesterol (TC) Low-density Lipoprotein-cholesterol (LDL-C) Very Low-density Lipoprotein-cholesterol (VLDL-C) High-density Lipoprotein-cholesterol (HDL-C) Triglyceride (TG) Free Fatty Acid (FFA)
Time Frame
week 0, week 16
Title
Change in Fasting Lipid Profile, APO-B
Description
Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).
Time Frame
week 0, week 16
Title
Hypoglycaemic Episodes
Description
Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame
weeks 0-16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy BMI less than 45.0 kg/m^2 Exclusion Criteria: Treatment with insulin within the last 3 months prior to the trial Impaired liver or/and renal function Significant cardiovascular disease over the last 6 months Known retinopathy or maculopathy Recurrent major hypoglycaemia or hypoglycaemic unawareness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452), MD, PhD
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderbad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 015
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Cochin
State/Province
Kerala
ZIP/Postal Code
695010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 037
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751019
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 013
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Cochin
ZIP/Postal Code
682 304
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ghaziabad
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
ZIP/Postal Code
700017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
ZIP/Postal Code
700026
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
ZIP/Postal Code
400 0067
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
ZIP/Postal Code
400016
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Patna
ZIP/Postal Code
800020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Secunderabad
ZIP/Postal Code
500 003
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Trivandrum
ZIP/Postal Code
695029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Visakhapatnam
ZIP/Postal Code
530002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Goyang
ZIP/Postal Code
410-719
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Incheon
ZIP/Postal Code
405-220
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Sungnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21114607
Citation
Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, Bhattacharyya A, Kumar A, Kim KW, Yoon KH, Bech OM, Zychma M. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.x.
Results Reference
result
PubMed Identifier
23010561
Citation
Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
Results Reference
result
PubMed Identifier
25504028
Citation
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.
Results Reference
result
PubMed Identifier
25684604
Citation
Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19.
Results Reference
result
PubMed Identifier
21450987
Citation
Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

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