Evaluate Efficacy and Safety of Saxagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes

Study identifier:D1680C00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin, Placebo, Metformin

Sex

All

Actual Enrollment

570

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2008
Primary Completion Date: 01 Sept 2009
Study Completion Date: 01 Sept 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria