A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

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 to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: placebo
* Drug: taspoglutide
* Drug: taspoglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-80 years of age; drug naive patients with type 2 diabetes uncontrolled with diet and exercise; tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies; C-peptide (fasting) >=1.0ng/mL HbA1c >=6.5% and <=10.0% at screening; BMI >=25 (>23 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 mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; evidence of clinically significant diabetic complications; symptomatic poorly controlled diabetes; myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; known hemoglobinopathy or chronic anemia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 10mg sc<br> | Drug: taspoglutide<br>* 10mg sc, once weekly<br>|
| Experimental: taspoglutide 10mg/20mg sc<br> | Drug: taspoglutide<br>* 20mg sc, once weekly (after 4 weeks of taspoglutide 10mg 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 |
| --- | --- | --- |
| Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. |  | Throughout study | 
| Change from baseline in fasting plasma glucose; change from baseline in body weight. |  | 24 weeks | 
| Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function. |  | 24 weeks |