This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
746
1.8 mg for s.c. (under the skin) injection
8 mg capsule
1.2 mg for s.c. (under the skin) injection
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
Time frame: week 0, week 52
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
Time frame: week 0, week 104
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
Time frame: week 0, week 156
Change in Body Weight at Week 52
Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)
Time frame: week 0, week 52
Change in Body Weight at Week 104
Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)
Time frame: week 0, week 104
Change in Body Weight at Week 156
Change in body weight from baseline (week 0) to 156 weeks
Time frame: week 0, week 156
Change in Fasting Plasma Glucose at Week 52
Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)
Time frame: week 0, week 52
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Glimepiride placebo, 8mg capsule
Liraglutide placebo, 200 mcl
Liraglutide placebo, 300 mcl
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Escondido, California, United States
Novo Nordisk Investigational Site
Fullerton, California, United States
Novo Nordisk Investigational Site
Inglewood, California, United States
Novo Nordisk Investigational Site
Mission Viejo, California, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Santa Barbara, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Vista, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
...and 107 more locations
Change in Fasting Plasma Glucose at Week 104
Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)
Time frame: week 0, week 104
Change in Fasting Plasma Glucose at Week 156
Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks
Time frame: week 0, week 156
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Time frame: week 0, week 52
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Time frame: week 0, week 104
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Time frame: week 0, week 156
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Time frame: week 0, week 52
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Time frame: week 0, week 104
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Time frame: week 0, week 156
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Time frame: weeks 0-104
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Time frame: weeks 104-195