Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR- TIMI 53)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107886

D1680C00003

EudraCT No 2009-017358-10

Details and patient eligibility

About

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

Full 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

Enrollment: 18,206 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18,206 participants in 2 patient groups, including a placebo group

Saxagliptin

Experimental group

Treatment:

Drug: Saxagliptin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo