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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
929
0.6 mg/day, s.c. (under the skin) injection
Glimepiride placebo, capsules
1.2 mg/day, s.c. (under the skin) injection
Change in Glycosylated Haemoglobin A1c (HbA1c)
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).
Time frame: week 0, week 16
Change in Body Weight
Change in body weight from baseline (week 0) to 16 weeks (end of treatment)
Time frame: week 0, week 16
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.
Time frame: week 0, week 16
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).
Time frame: week 0, 8, 12 and 16
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).
Time frame: week 0, week 16
Change in Fasting Lipid Profile
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1.8 mg/day, s.c. (under the skin) injection
Capsules, 4.0 mg/day
Tablets, 1.5-2.0 g/day
Liraglutide placebo, s.c. (under the skin) injection
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Fuzhou, Fujian, China
Novo Nordisk Investigational Site
Harbin, Heilongjiang, China
Novo Nordisk Investigational Site
Harbin, Heilongjiang, China
Novo Nordisk Investigational Site
Wuhan, Hubei, China
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China
Novo Nordisk Investigational Site
Suzhou, Jiangsu, China
Novo Nordisk Investigational Site
Wuxi, Jiangsu, China
...and 40 more locations
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)
Time frame: week 0, week 16
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).
Time frame: week 0, week 16
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.
Time frame: weeks 0-16