Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Saxagliptin; Drug: Placebo

• Registration Number: NCT01107886
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Study Start: 2010-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-05-15
• Results First Submitted QC: 2014-05-15
• Results First Posted: 2014-06-13
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18206

Inclusion Criteria

• Patients with type 2 diabetes mellitus
• HbA1c ≥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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin	Saxagliptin	-
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke	Randomization (day 0) up to 2.9 years	Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.

Secondary Outcome Measures

Name	Time	Method
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation	Randomization (day 0) up to 2.9 years	Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Participants With Event of Death	Randomization (day 0) up to 2.9 years	Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Whitstable, United Kingdom