A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.

Official Title
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A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease

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 years of age diabetes mellitus type 2 HbA1c >/=6.5% and </=10% at screening BMI >/=23kg/m2 cardiovascular disease with onset >/=1 month prior to screening Exclusion Criteria: diagnosis or history of type 1 diabetes or secondary forms of diabetes acute metabolic diabetic complications within past 6 months severe hypoglycemia </=1 month prior to screening clinically significant gastrointestinal disease history of chronic or acute pancreatitis current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy severely impaired renal function

Ages Eligible for Study
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Minimum Age: 18 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 weekly<br>|
| Experimental: taspoglutide<br> | Drug: taspoglutide<br>* 10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cardiovascular composite primary endpoints |  | event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary cardiovascular composite endpoints |  | event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter | 
| Individual components of primary cardiovascular composite endpoints |  | event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter | 
| Total mortality |  | assessed at end of study, week 104 | 
| Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR) |  | laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter |