A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
- Registration Number
- NCT00423501
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
Inclusion Criteria
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- stable weight +/-10% for >=3 months before screening.
Exclusion Criteria
- type 1 diabetes mellitus;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 taspoglutide - 1 taspoglutide - 6 Placebo - 2 taspoglutide - 3 taspoglutide - 5 taspoglutide -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in HbAlc Week 8
- Secondary Outcome Measures
Name Time Method Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. Week 8 AEs, laboratory parameters, primary pharmacokinetic parameters Throughout study Changes in lipid profile Week 8