At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 815 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for dapagliflozin for Type 1 Diabetes Mellitus. Completed, enrolled 815 participants across 136 sites in 13 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesArgentina, Belgium, Canada, Chile, Germany, Japan, Netherlands, Poland, Russia, Sweden, Switzerland, United Kingdom, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJul 2015
Primary CompletionSep 2017
Study CompletionApr 2018
TodayJul 2026
First PostedJun 3, 2015
Enrollment StartJul 8, 2015
Primary CompletionSep 2, 2017
Study CompletionApr 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.1 years ago
Interventions
Dapagliflozindrug
Tablets
Placebo for dapagliflozinother
Tablets