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

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-017358-10-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2013-05-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16500

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified