To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- Registration Number
- NCT00318461
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1091
- Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
- HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
- Body Mass Index (BMI) less than or equal 40 kg/m2
- Subjects treated with insulin within the last three months
- Subjects with any serious medical condition
- Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
- Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Met Mono placebo Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo Lira 0.6 + Met liraglutide Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Lira 0.6 + Met metformin Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Lira 0.6 + Met placebo Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Lira 1.2 + Met placebo Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Lira 1.8 + Met placebo Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Met + Glim placebo Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo Lira 1.2 + Met metformin Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Lira 1.2 + Met liraglutide Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Lira 1.8 + Met metformin Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Met Mono metformin Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo Lira 1.8 + Met liraglutide Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day Met + Glim glimepiride Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo Met + Glim metformin Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
- Primary Outcome Measures
Name Time Method Change in Glycosylated A1c (HbA1c) at Week 26 week 0, week 26 Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
Change in Glycosylated A1c (HbA1c) at Week 104 week 0, week 104 Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)
- Secondary Outcome Measures
Name Time Method Change in Body Weight at Week 26 week 0, week 26 Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
Change in Body Weight at Week 104 week 0, week 104 Change in body weight from baseline (week 0) to 104 weeks (end of treatment)
Change in Fasting Plasma Glucose (FPG) at Week 26 week 0, week 26 Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
Change in Fasting Plasma Glucose (FPG) at Week 104 week 0, week 104 Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26 week 0, week 26 Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104 week 0, week 104 Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26 week 0, week 26 Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104 week 0, week 104 Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
Change in Beta-cell Function at Week 26 week 0, week 26 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).Change in Beta-cell Function at Week 104 week 0, week 104 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).Hypoglycaemic Episodes at Week 26 weeks 0-26 Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). 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.
Hypoglycaemic Episodes at Week 104 weeks 0-104 Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end 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
🇬🇧Sunbury on Thames, United Kingdom