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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154414

NN2211-1334

JapicCTI-050131 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

Enrollment: 226 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy
• 7.0 % =< HbA1c < 10.0 %
• Body Mass Index (BMI) < 30.0 kg/m^2

Exclusion criteria

• Subjects treated with thiazolidinediones or insulin
• Subjects with any serious medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind