At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 171 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 1 mgfrom 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 Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating Dapagliflozin and Placebo matching Dapagliflozin for Type 1 Diabetes Mellitus. Completed, enrolled 171 participants across 12 sites.
Detailed Summary
To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsAstra Zeneca, Bristol-Myers Squibb
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartFeb 2012
Primary CompletionOct 2012
TodayJul 2026
First PostedDec 23, 2011
Enrollment StartFeb 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.5 years ago
Interventions
Dapagliflozindrug
Tablets, Oral, 1 mg, Once daily, 14 days
Placebo matching Dapagliflozindrug
Tablets, Oral, 0 mg, Once daily, 14 days