CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 597 enrolled
Drug / intervention
dapagliflozin +4 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/NCT00680745
NCT00680745Phase 3Completed

A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

AstraZeneca·interventional·Posted May 20, 2008·Updated Oct 14, 2013

In Brief

A Phase 3 clinical trial evaluating dapagliflozin, Glimepiride, and 3 other interventions for Type 2 Diabetes. Completed, enrolled 597 participants across 66 sites in 7 countries.

Detailed Summary

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesCzechia, Hungary, Philippines, Poland, South Korea, Thailand, Ukraine

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartApr 1, 2008
Primary CompletionNov 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.1 years ago

Interventions

dapagliflozindrug

tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

Glimepiridedrug

tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

metformin hydrochloridedrug

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

pioglitazone hydrochloridedrug

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Rosiglitazonedrug

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice