Evaluation of dapagliflozin taken twice-daily

Study identifier:D1691C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients with Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

dapagliflozin, metformin, placebo

Sex

All

Actual Enrollment

400

Study type

Interventional

Age

18 Years - 77 Years

Date

Study Start Date: 01 Nov 2010
Primary Completion Date: 01 Aug 2011
Study Completion Date: 01 Aug 2011

Study design

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

Verification:

Verified 01 Oct 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria