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

January 25, 2017 updated by: Novo Nordisk A/S

Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
Liraglutide 0.9 mg + glibenclamide placebo
Drug: liraglutide
0.9 mg/day. Injected s.c. (under the skin) once daily.
Drug: placebo
liraglutide placebo. Injected s.c. (under the skin) once daily.
Drug: placebo
glibenclamide placebo. Given orally once or twice daily.
Active Comparator: Glibenclamide
Glibenclamide 1.25-2.5 mg + liraglutide placebo
Drug: placebo
liraglutide placebo. Injected s.c. (under the skin) once daily.
Drug: placebo
glibenclamide placebo. Given orally once or twice daily.
Drug: glibenclamide
1.25-2.5 mg tablet. Given orally once or twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
after 52 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Time Frame: 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.
after 24 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Time Frame: 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.
after 52 weeks of treatment
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Time Frame: 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.
after 24 weeks of treatment
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Time Frame: 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.
after 52 weeks of treatment
Body Weight After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment
Body Weight After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
after 52 weeks of treatment
Hypoglycaemic Episodes
Time Frame: 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.
over 52 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 27, 2006

First Submitted That Met QC Criteria

October 27, 2006

First Posted (Estimate)

October 29, 2006

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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