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

Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus. A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001302

Enrollment

16500

Registered

2011-02-17

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- 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

Interventions

Intervention1: Saxagliptin: Tablet, once daily up to 5 years Control Intervention1: Placebo: Tablet to match Saxagliptin, once daily up to 5 years

Eligibility

Inclusion criteria

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

Exclusion criteria: - Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics - Acute vascular event <2months prior to randomisation

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

Argentina, Australia, Brazil, Canada, Chile, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States of America

Contacts

Public ContactDr Ramesh Jagannathan

Medical Contact of Sponsor

Bhavesh.Kotak@astrazeneca.com08067748514

Outcome results

None listed

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