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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: Taspoglutide 20mg
* Drug: Taspoglutide 20mg-30mg
* Drug: Taspoglutide 20mg-40mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>sc weekly | Drug: Placebo<br>* sc weekly<br>|
| Experimental: Taspoglutide 20mg<br>sc weekly | Drug: Taspoglutide 20mg<br>* sc weekly<br>|
| Experimental: Taspoglutide 20mg-30mg<br>sc weekly | Drug: Taspoglutide 20mg-30mg<br>* sc weekly<br>|
| Experimental: Taspoglutide 20mg-40mg<br>sc weekly | Drug: Taspoglutide 20mg-40mg<br>* sc weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients withdrawn because of gastrointestinal effects |  | Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |