Efficacy and Safety of Dapagliflozin in Combination with Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

Study identifier:D1690C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-controlled Phase III Study with a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.with Glimepiride (a Sulphonylurea) in Subjects with Type2 Diab.who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

dapagliflozin, dapagliflozin, dapagliflozin, Glimepiride, Glimepiride, Glimepiride, Glimepiride, metformin hydrochloride, metformin hydrochloride, metformin hydrochloride, metformin hydrochloride, pioglitazone hydrochloride, pioglitazone hydrochloride, pioglitazone hydrochloride, pioglitazone hydrochloride, Rosiglitazone, Rosiglitazone, Rosiglitazone, Rosiglitazone

Sex

All

Actual enrollment

597

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Apr 2008
Primary Completion Date: 01 Nov 2009
Study Completion Date: 01 May 2010

Study design

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

Verification:

Verified 01 Aug 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria