Efficacy and Safety of Dapagliflozin in Combination with Metformin in Type 2 Diabetes Patients

Study identifier:D1690C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study with a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with Sulphonylurea in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone.

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

dapagliflozin, glipizide, metformin hydrochloride

Sex

All

Actual Enrollment

1217

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Mar 2008
Primary Completion Date: 01 Dec 2009
Study Completion Date: 01 Jan 2013

Study design

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

Verification:

Verified 01 Mar 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria