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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614120
• Other study ID #: NN2211-1796
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2008
• Last updated: October 29, 2014
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)India: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 929
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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
0.6 mg/day, s.c. (under the skin) injection
• placebo
Glimepiride placebo, capsules
• liraglutide
1.2 mg/day, s.c. (under the skin) injection
• liraglutide
1.8 mg/day, s.c. (under the skin) injection
• glimepiride
Capsules, 4.0 mg/day
• metformin
Tablets, 1.5-2.0 g/day
• placebo
Liraglutide placebo, s.c. (under the skin) injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

China,  India,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin A1c (HbA1c)	Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).	week 0, week 16	No
Secondary	Change in Body Weight	Change in body weight from baseline (week 0) to 16 weeks (end of treatment)	week 0, week 16	No
Secondary	Change in Self-measured Fasting Plasma Glucose	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.	week 0, week 16	No
Secondary	7-point Self-measured Plasma Glucose Profiles	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).	week 0, 8, 12 and 16	No
Secondary	Change in Beta-cell Function	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).	week 0, week 16	No
Secondary	Change in Fasting Lipid Profile	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)	week 0, week 16	No
Secondary	Change in Fasting Lipid Profile, APO-B	Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).	week 0, week 16	No
Secondary	Hypoglycaemic Episodes	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.	weeks 0-16	Yes

External Links

•   Clinical Trials at Novo Nordisk