CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 915 enrolled
Drug / intervention
Dapagliflozin +2 moredrug
Likely dose
Metformin 1500 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/NCT00528879
NCT00528879Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

AstraZeneca·interventional·Posted Sep 12, 2007·Updated Oct 20, 2015

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin, Placebo, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 915 participants across 75 sites in 5 countries.

Detailed Summary

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, Brazil, Canada, Mexico, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2007
Enrollment StartSep 1, 2007
Primary CompletionNov 1, 2008
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.8 years ago

Interventions

Dapagliflozindrug

Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks

Placebodrug

Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks

Metformindrug

Open-label metformin administered as ≥1500 mg per day for up to 102 weeks