A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Study Overview
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Brief Summary
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This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

Official Title
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Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: exenatide
* Drug: taspoglutide
* 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 receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks; HbA1c >=7.0% and <=10% at screening; BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening; stable weight +/- 5% for at least 12 weeks prior to screening. Exclusion Criteria: history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes; history of acute metabolic diabetic complications within the previous 6 months; evidence of clinically significant diabetic complications; known proliferative diabetic retinopathy; myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months; any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator; known hemoglobinopathy or chronic anemia; clinically significant gastrointestinal disease.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: exenatide<br> | Drug: exenatide<br>* 5mg twice daily for 4 weeks followed by 10mg twice daily<br>|
| Experimental: taspoglutide 10mg<br> | Drug: taspoglutide<br>* 10mg once weekly<br>|
| Experimental: taspoglutide 10mg/20mg<br> | Drug: taspoglutide<br>* 10mg once weekly for 4 weeks followed by 20mg once weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting body weight |  | 24 weeks | 
| Proportion of patients reaching target HbA1c <=7.0%, <=6.5% |  | 24 weeks | 
| Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. |  | 24 weeks | 
| Beta cell function (proinsulin/insulin ratio) |  | 24 weeks |