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

Phase 2

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00154401
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
• Diet treated subjects: 7.5% < HbA1c < 10%
• Single oral drug therapy subjects: 7.0% < HbA1c < 9.5%
• Body Mass Index (BMI): max 40 kg/m^2

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 14 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Body weight after 14 weeks.
Safety and tolerability
Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Zilina, Slovakia