Study identifier:MB102-230
ClinicalTrials.gov identifier:NCT02460978
EudraCT identifier:2014-004599-49
CTIS identifier:N/A
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus - Study Two
Type 1 Diabetes Mellitus
Phase 3
No
Dapagliflozin
All
815
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2019 by AstraZeneca
AstraZeneca
Bristol-Myers Squibb
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin 5 mg Dapagliflozin 5 mg tablet orally, once daily for 52 weeks | Drug: Dapagliflozin Tablets |
Experimental: Dapagliflozin 10 mg Dapagliflozin 10 mg tablet orally, once daily for 52 weeks | Drug: Dapagliflozin Tablets |
Placebo Comparator: Placebo Placebo tablet orally, once daily for 52 weeks | Other: Placebo for dapagliflozin Tablets |