At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 417 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 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
In Brief
A Phase 2 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 417 participants across 20 sites.
Detailed Summary
The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesJapan
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionMay 2010
TodayJul 2026
First PostedSep 4, 2009
Enrollment StartAug 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.8 years ago
Interventions
Dapagliflozindrug
once daily, 12 weeks
Placebodrug
once daily, 12 weeks