This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
0.9 mg/day. Injected s.c. (under the skin) once daily.
1.25-2.5 mg tablet. Given orally once or twice daily.
liraglutide placebo. Injected s.c. (under the skin) once daily.
Novo Nordisk Investigational Site
Tokyo, Japan
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
Time frame: after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment
Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
Time frame: after 52 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Time frame: after 24 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
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glibenclamide placebo. Given orally once or twice daily.
Time frame: after 52 weeks of treatment
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Time frame: after 24 weeks of treatment
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Time frame: after 52 weeks of treatment
Body Weight After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment
Body Weight After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Hypoglycaemic Episodes
Hypoglycaemic episodes measured over 52 weeks 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.
Time frame: over 52 weeks of treatment