Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: glibenclamide; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393718

NN2211-1700

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
• HbA1c greater than or equal to 7.0% and less than 10.0%
• BMI (Body Mass Index) 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Liraglutide

Experimental group

Description:

Liraglutide 0.9 mg + glibenclamide placebo

Treatment:

Drug: placebo

Drug: liraglutide

Drug: placebo

Glibenclamide

Active Comparator group

Description:

Glibenclamide 1.25-2.5 mg + liraglutide placebo

Treatment:

Drug: placebo

Drug: glibenclamide

Drug: placebo