Study identifier:MB102-229
ClinicalTrials.gov identifier:NCT02268214
EudraCT identifier:2013-004674-97
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
Type 1 Diabetes Mellitus
Phase 3
No
Dapagliflozin, Placebo for dapagliflozin
All
833
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2018 by AstraZeneca
AstraZeneca
Bristol-Myers Squibb
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Location
Location
Wien, Austria, 1090
Location
Wien, Austria, 1060
Location
St. Stefan/Stainz, Austria, 8511
Location
Innsbruck, Austria, 6020
Location
Wien, Austria, 1130
Location
Heidelberg West, Australia, 3081
Location
Daw Park, Australia, 5041
Location
Concord, Australia, 2139
Arms | Assigned Interventions |
---|---|
Experimental: Arm A: Dapagliflozin Dapagliflozin 5 mg tablet orally, once daily for 52 weeks | Drug: Dapagliflozin Tablets |
Experimental: Arm B: Dapagliflozin Dapagliflozin 10 mg tablet orally, once daily for 52 weeks | Drug: Dapagliflozin Tablets |
Placebo Comparator: Arm C: Placebo for Dapagliflozin Placebo tablet orally, once daily for 52 weeks | Drug: Placebo for dapagliflozin Tablets |
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