Evaluation of dapagliflozin taken twice-daily
Study identifier:D1691C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients with Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
dapagliflozin, metformin, placebo
Sex
All
Actual Enrollment
400
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 Nov 2010
Primary Completion Date: 01 Aug 2011
Study Completion Date: 01 Aug 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Dapagliflozin 2.5 mg twice-daily plus open-label metformin | Drug: dapagliflozin 2.5 mg tablet, taken orally, twice daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily |
| Experimental: 2 Dapagliflozin 5.0 mg twice-daily plus open-label metformin | Drug: dapagliflozin 5 mg tablet taken orally, twice daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily |
| Experimental: 3 Dapagliflozin 10 mg once-daily plus open-label metformin | Drug: dapagliflozin 10 mg tablet taken orally, once daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily |
| Placebo Comparator: 4 Placebo plus open-label metformin | Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily Drug: placebo placebo |
Contacts
Investigators
Principal Investigator
Shamik Parikh
AstraZeneca
