Add-on to Thiazolidinedione (TZD) Failures

Study identifier:MB102-030

ClinicalTrials.gov identifier:NCT00683878

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 in Combination with Thiazolidinedione Therapy in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Dapagliflozin, Placebo matching Dapagliflozin, Thiazolidinedione (Pioglitazone)

Sex

All

Actual Enrollment

972

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jul 2008
Primary Completion Date: 01 Jan 2010
Study Completion Date: 01 Jun 2010

Study design

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

Verification:

Verified 01 Jan 2017 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra-Zeneca, Bristol-Myers Squibb

Inclusion and exclusion criteria