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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393718
• Other study ID #: NN2211-1700
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2006
• Last updated: November 17, 2014
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labour and Welfare (MHLW)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
0.9 mg/day. Injected s.c. (under the skin) once daily.
• glibenclamide
1.25-2.5 mg tablet. Given orally once or twice daily.
• placebo
liraglutide placebo. Injected s.c. (under the skin) once daily.
• placebo
glibenclamide placebo. Given orally once or twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment		after 24 weeks of treatment	No
Secondary	Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment		after 52 weeks of treatment	No
Secondary	Fasting Plasma Glucose After 24 Weeks of Treatment		after 24 weeks of treatment	No
Secondary	Fasting Plasma Glucose After 52 Weeks of Treatment		after 52 weeks of treatment	No
Secondary	Postprandial Glucose AUC 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	No
Secondary	Postprandial Glucose AUC 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	No
Secondary	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.	after 24 weeks of treatment	No
Secondary	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.	after 52 weeks of treatment	No
Secondary	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.	after 24 weeks of treatment	No
Secondary	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.	after 52 weeks of treatment	No
Secondary	Body Weight After 24 Weeks of Treatment		after 24 weeks of treatment	No
Secondary	Body Weight After 52 Weeks of Treatment		after 52 weeks of treatment	No
Secondary	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.	over 52 weeks of treatment	Yes

External Links

•   Clinical Trials at Novo Nordisk