A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Study identifier:MB102-054

ClinicalTrials.gov identifier:NCT01095653

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Dapagliflozin, Metformin, Dapagliflozin Placebo

Sex

All

Actual Enrollment

1179

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Mar 2012
Study Completion Date: 01 Mar 2012

Study design

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

Verification:

Verified 01 Dec 2016 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

AstraZeneca, Bristol-Myers Squibb

Inclusion and exclusion criteria