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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
liraglutide
glibenclamide
placebo
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

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liraglutide

Glibenclamide

Arm Description

Liraglutide 0.9 mg + glibenclamide placebo

Glibenclamide 1.25-2.5 mg + liraglutide placebo

Outcomes

Primary Outcome Measures

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

Secondary Outcome Measures

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
Postprandial Glucose AUC 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
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
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
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
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
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
Body Weight After 52 Weeks of Treatment
Hypoglycaemic Episodes
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.

Full Information

First Posted
October 27, 2006
Last Updated
January 25, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00393718
Brief Title
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Official Title
Effect of Liraglutide 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
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
May 2008 (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 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.

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
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
Liraglutide 0.9 mg + glibenclamide placebo
Arm Title
Glibenclamide
Arm Type
Active Comparator
Arm Description
Glibenclamide 1.25-2.5 mg + liraglutide placebo
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
0.9 mg/day. Injected s.c. (under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
glibenclamide
Intervention Description
1.25-2.5 mg tablet. Given orally once or twice daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
liraglutide placebo. Injected s.c. (under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
glibenclamide placebo. Given orally once or twice daily.
Primary Outcome Measure Information:
Title
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Time Frame
after 24 weeks of treatment
Secondary Outcome Measure Information:
Title
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Time Frame
after 52 weeks of treatment
Title
Fasting Plasma Glucose After 24 Weeks of Treatment
Time Frame
after 24 weeks of treatment
Title
Fasting Plasma Glucose After 52 Weeks of Treatment
Time Frame
after 52 weeks of treatment
Title
Postprandial Glucose AUC After 24 Weeks of Treatment
Description
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
Time Frame
after 24 weeks of treatment
Title
Postprandial Glucose AUC After 52 Weeks of Treatment
Description
Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
Time Frame
after 52 weeks of treatment
Title
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Description
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.
Time Frame
after 24 weeks of treatment
Title
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Description
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.
Time Frame
after 52 weeks of treatment
Title
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Description
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.
Time Frame
after 24 weeks of treatment
Title
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Description
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.
Time Frame
after 52 weeks of treatment
Title
Body Weight After 24 Weeks of Treatment
Time Frame
after 24 weeks of treatment
Title
Body Weight After 52 Weeks of Treatment
Time Frame
after 52 weeks of treatment
Title
Hypoglycaemic Episodes
Description
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.
Time Frame
over 52 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20199137
Citation
Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22. doi: 10.1185/03007991003672551.
Results Reference
result
PubMed Identifier
24843595
Citation
Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.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
21209033
Citation
Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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