At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,996 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 10 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo-matching dapagliflozin for Type 2 Diabetes. Completed, enrolled 2,996 participants across 329 sites in 16 countries.
Detailed Summary
The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesCanada, Colombia, Czechia, Denmark, Finland, Germany, Hungary, India, Mexico, Peru, Poland, Puerto Rico, Romania, Russia, Spain, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartJul 2010
Primary CompletionFeb 2013
TodayJul 2026
First PostedJun 4, 2010
Enrollment StartJul 1, 2010
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.1 years ago
Interventions
Dapagliflozindrug
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Placebo-matching dapagliflozindrug
Oral tablets administered as 0 mg once daily for up to 12 weeks