A Phase III Study of BMS-512148 (Dapagliflozin) in patients with Type 2 Diabetes who are not well controlled with Diet and Exercise

Study identifier:MB102-013 LT

ClinicalTrials.gov identifier:N/A

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 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, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin, Dapagliflozin placebo, Metformin, Metformin, Metformin, Metformin, Metformin, Metformin, Metformin, Metformin, Metformin

Sex

All

Actual enrollment

1067

Study type

Interventional

Age

18 Years - 77 Years

Date

Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Feb 2009
Study Completion Date: 01 Jul 2010

Study design

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

Verification:

Verified 01 Jul 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra Zeneca

Inclusion and exclusion criteria