Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects with Type 2 Diabetes Who have Inadequate Glycaemic Control with Diet and Exercise alone
Study identifier:D1693C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment on Hold
Official Title
A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects with Type 2 Diabetes Who have Inadequate Glycaemic Control with Diet and Exercise alone.
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin, placebo
Sex
All
Actual Enrollment
375
Study type
Interventional
Age
19 Years +
Date
Study Start Date: 01 Jan 2012
Estimated Primary Completion Date: 01 Jun 2013
Estimated Study Completion Date: 01 Jun 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: Dapagliflozin 5mg Oral dose od |
| Experimental: 2 | Drug: Dapagliflozin 10 mg Oral dose od |
| Placebo Comparator: 3 | Drug: placebo 5/10 mg Oral dose od |
Contacts
Investigators
Principal Investigator
Prof. A. Ramachandran
Dr. A. Ramachandran's Diabetes Hospital
