A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Taspoglutide 20mg-40mg; Drug: Taspoglutide 20mg-30mg; Drug: Placebo; Drug: Taspoglutide 20mg

• Registration Number: NCT00460941
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-16
• Study First Submitted QC: 2007-04-16
• Study First Posted: 2007-04-17
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2016-06-28
• Disposition First Submitted QC: 2016-06-28
• Disposition First Posted: 2016-06-30
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
• type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
• HbA1c >=7.0% and <=9.5% at screening;
• stable weight +/-10% for >=3 months before screening.

Exclusion Criteria

• type 1 diabetes mellitus;
• clinically significant gastrointestinal disease;
• treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
• use of weight-lowering medications in the last 3 months;
• uncontrolled hypertension;
• previous exposure to GLP-1 or GLP-1 analogues.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taspoglutide 20mg-40mg	Taspoglutide 20mg-40mg	sc weekly
Taspoglutide 20mg-30mg	Taspoglutide 20mg-30mg	sc weekly
Placebo	Placebo	sc weekly
Taspoglutide 20mg	Taspoglutide 20mg	sc weekly

Primary Outcome Measures

Name	Time	Method
Percentage of patients withdrawn because of gastrointestinal effects	Week 9

Secondary Outcome Measures

Name	Time	Method
Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.	Week 9