A trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients with type 2 diabetes mellitus HbA1c ¡Ý6.5%. (last measured within 6 months) High risk for CV events -Established cardiovascular disease and/or multiple risk factors Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2010/091/001302
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 463
Inclusion Criteria
Patients with type 2 diabetes mellitus
- HbA1c greater than or equal 6.5%. (based on the last measured and documented laboratory measurement within 6 months)
- High risk for CV events -Established cardiovascular disease and/or multiple risk factors
Exclusion Criteria
- Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
- Acute vascular event <2months prior to randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke.Timepoint: Time to first event. Information collected during study period (anticipated to be 5 years).
- Secondary Outcome Measures
Name Time Method The composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, unstable angina pectoris or coronary revascularisationTimepoint: Time to first event. Information collected during study period (anticipated to be 5 years)