Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: NCT00393718
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-27
• Study First Submitted QC: 2006-10-27
• Study First Posted: 2006-10-29
• Study Start: 2006-11
• Primary Completion: 2007-11
• Study Completion: 2008-05
• Disposition First Submitted: 2009-10-26
• Disposition First Submitted QC: 2009-10-26
• Disposition First Posted: 2009-10-28
• 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: 400

Inclusion Criteria

• Type 2 diabetes
• Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
• HbA1c greater than or equal to 7.0% and less than 10.0%
• BMI (Body Mass Index) less than 35 kg/m2

Exclusion Criteria

• Treatment with insulin within the last 12 weeks
• Treatment with any drug that could interfere with the glucose level
• Any serious medical condition
• Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide	placebo	Liraglutide 0.9 mg + glibenclamide placebo
Glibenclamide	placebo	Glibenclamide 1.25-2.5 mg + liraglutide placebo
Liraglutide	liraglutide	Liraglutide 0.9 mg + glibenclamide placebo
Glibenclamide	glibenclamide	Glibenclamide 1.25-2.5 mg + liraglutide placebo

Primary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment	after 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment	after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment	after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment	after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment	after 24 weeks of treatment	Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment	after 52 weeks of treatment	Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment	after 24 weeks of treatment	Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment	after 52 weeks of treatment	Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment	after 24 weeks of treatment	Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment	after 52 weeks of treatment	Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Body Weight After 24 Weeks of Treatment	after 24 weeks of treatment
Body Weight After 52 Weeks of Treatment	after 52 weeks of treatment
Hypoglycaemic Episodes	over 52 weeks of treatment	Hypoglycaemic episodes measured over 52 weeks of treatment. 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; 🇯🇵 Tokyo, Japan