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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

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Met MonoplaceboMetformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
Lira 0.6 + MetliraglutideLiraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Lira 0.6 + MetmetforminLiraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Lira 0.6 + MetplaceboLiraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Lira 1.2 + MetplaceboLiraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Lira 1.8 + MetplaceboLiraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Met + GlimplaceboGlimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Lira 1.2 + MetmetforminLiraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Lira 1.2 + MetliraglutideLiraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Lira 1.8 + MetmetforminLiraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Met MonometforminMetformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
Lira 1.8 + MetliraglutideLiraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Met + GlimglimepirideGlimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Met + GlimmetforminGlimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Primary Outcome Measures
NameTimeMethod
Change in Glycosylated A1c (HbA1c) at Week 26week 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 104week 0, week 104

Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)

Secondary Outcome Measures
NameTimeMethod
Change in Body Weight at Week 26week 0, week 26

Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)

Change in Body Weight at Week 104week 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 26week 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 104week 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 26week 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 104week 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 26week 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 104week 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 26week 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 104week 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 26weeks 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 104weeks 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

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