Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Official Title
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Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: sulfonylurea
* Drug: liraglutide
* Drug: liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks HbA1c greater than or equal to 7.0% and less than 10.0% BMI less than 35 kg/m2 Exclusion Criteria: Treatment with insulin within the last 12 weeks Treatment with any drug that could interfere with the glucose level Any serious medical condition Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.6 mg + SU<br>Liraglutide 0.6 mg + sulphonylurea | Drug: sulfonylurea<br>* SU agent<br>Drug: liraglutide<br>* Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.<br>|
| Experimental: 0.9 mg + SU<br>Liraglutide 0.9 mg + sulphonylurea | Drug: sulfonylurea<br>* SU agent<br>Drug: liraglutide<br>* Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.<br>|
| Placebo Comparator: SU Mono - 1<br>Liraglutide placebo 0.6 mg + sulphonylurea | Drug: sulfonylurea<br>* SU agent<br>|
| Placebo Comparator: SU Mono - 2<br>Liraglutide placebo 0.9 mg + sulphonylurea | Drug: sulfonylurea<br>* SU agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment |  | after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment |  | after 52 weeks of treatment | 
| Fasting Plasma Glucose After 24 Weeks of Treatment |  | after 24 weeks of treatment | 
| Fasting Plasma Glucose After 52 Weeks of Treatment |  | 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 | 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 | 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 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. | after 24 weeks of treatment | 
| Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment | 7-point plasma glucose (PG) 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. | 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. | 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. | after 52 weeks of treatment | 
| Body Weight After 24 Weeks of Treatment |  | after 24 weeks of treatment | 
| Body Weight After 52 Weeks of Treatment |  | 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. | over 52 weeks of treatment |