A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

Study Overview
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Brief Summary
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This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: placebo
* Drug: taspoglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks; HbA1c >=6.5% and <=9.5% at screening; BMI >=30 and <=50 kg/m2 at screening; stable weight +/-5% for at least 12 weeks prior to screening. Exclusion Criteria: history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months; evidence of clinically significant diabetic complications; myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

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> | Drug: placebo<br>* sc once weekly<br>|
| Experimental: taspoglutide<br> | Drug: taspoglutide<br>* 10mg sc once weekly for 4 weeks, then 20mg sc once weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in HbA1c |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight;% of patients achieving >=5% weight loss |  | 24 weeks | 
| % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function |  | 24 weeks | 
| Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n |  | At planned clinic visits, for 12 months |