Effect of Liraglutide in Combination With Sulfonylurea (SU) 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: liraglutide; Drug: sulfonylurea

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395746

NN2211-1701

JapicCTI-060324 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 264 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 4 patient groups, including a placebo group

0.6 mg + SU

Experimental group

Description:

Liraglutide 0.6 mg + sulphonylurea

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: sulfonylurea

0.9 mg + SU

Experimental group

Description:

Liraglutide 0.9 mg + sulphonylurea

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: sulfonylurea

SU Mono - 1

Placebo Comparator group

Description:

Liraglutide placebo 0.6 mg + sulphonylurea

Treatment:

Drug: sulfonylurea

SU Mono - 2

Placebo Comparator group

Description:

Liraglutide placebo 0.9 mg + sulphonylurea

Treatment:

Drug: sulfonylurea