CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 922 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.

Search/NCT01031680
NCT01031680Phase 3Completed
CompareCT.gov

A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care

AstraZeneca·interventional·Posted Dec 14, 2009·Updated Oct 29, 2013

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes Mellitus and 3 related conditions. Completed, enrolled 922 participants across 140 sites in 9 countries.

Detailed Summary

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension, Inadequate Glycaemic Control
CountriesArgentina, Canada, Germany, Romania, Slovakia, Spain, Taiwan, United States, Vietnam
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2009
Enrollment StartFeb 1, 2010
Primary CompletionMay 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.6 years ago

Interventions

Dapagliflozindrug

10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period

Placebodrug

Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period