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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000160

Enrollment

2000

Registered

2010-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Taspoglutide: 10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly Control Intervention1: Placebo Comparator: sc weekly

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Australia, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Lithuania, Malaysia, Mexico, Poland, Romania, Russian Federation, Slovakia, Spain, Thailand, Ukraine, United Kingdom, United States of America

Contacts

Public ContactSuchela Srivatsa

IQVIA RDS (India) Private Limited

shoibal.mukherjee@quintiles.com91-7838652395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026