A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
Phase 3
Completed
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2010/091/000160
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
Inclusion Criteria:
adult patients, more than 18 years of age
diabetes mellitus type 2
HbA1c more than or equal to 6.5% and less than or equal to 10% at screening
BMI more than or equal to 23kg/m2
cardiovascular disease with onset more than or equal to month prior to screening
Exclusion Criteria
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 NYHA class IV heart failure or post-transplantation cardiomyopathy
severely impaired renal function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first occurrence of any component of a cardiovascular composite endpoint (CV death, MI, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or hospitalization for heart failure)Timepoint: Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
- Secondary Outcome Measures
Name Time Method Secondary cardiovascular composite endpoints,Individual components of primary cardiovascular composite endpoints, Total mortality,Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, ACR, albuminuria, GFRTimepoint: weeks 1,4,12 and every 3 to 4 months thereafter