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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: glimepiride; Drug: liraglutide; Drug: placebo; Drug: metformin

• Registration Number: NCT00614120
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Disposition First Submitted: 2009-11-09
• Disposition First Submitted QC: 2009-11-09
• Disposition First Posted: 2009-11-11
• Results First Submitted: 2010-02-23
• Results First Submitted QC: 2010-02-23
• Results First Posted: 2010-03-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 929

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lira 1.2 + Met	liraglutide	Liraglutide 1.2 mg + metformin + glimepiride placebo
Lira 0.6 + Met	placebo	Liraglutide 0.6 mg + metformin + glimepiride placebo
Lira 0.6 + Met	metformin	Liraglutide 0.6 mg + metformin + glimepiride placebo
Lira 1.2 + Met	placebo	Liraglutide 1.2 mg + metformin + glimepiride placebo
Glim + Met	placebo	Glimepiride 4.0 mg + metformin + liraglutide placebo
Lira 1.8 + Met	placebo	Liraglutide + metformin + glimepiride placebo
Lira 0.6 + Met	liraglutide	Liraglutide 0.6 mg + metformin + glimepiride placebo
Lira 1.2 + Met	metformin	Liraglutide 1.2 mg + metformin + glimepiride placebo
Lira 1.8 + Met	metformin	Liraglutide + metformin + glimepiride placebo
Lira 1.8 + Met	liraglutide	Liraglutide + metformin + glimepiride placebo
Glim + Met	glimepiride	Glimepiride 4.0 mg + metformin + liraglutide placebo
Glim + Met	metformin	Glimepiride 4.0 mg + metformin + liraglutide placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight	week 0, week 16	Change in body weight from baseline (week 0) to 16 weeks (end of treatment)
Change in Self-measured Fasting Plasma Glucose	week 0, week 16	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.
Change in Beta-cell Function	week 0, week 16	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).
7-point Self-measured Plasma Glucose Profiles	week 0, 8, 12 and 16	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 Fasting Lipid Profile	week 0, week 16	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	week 0, week 16	Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).
Hypoglycaemic Episodes	weeks 0-16	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇰🇷 Suwon, Korea, Republic of