CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,447 enrolled
Drug / intervention
Rosiglitazone +2 moredrug
Likely dose
Rosiglitazone 8 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/NCT00379769
NCT00379769Phase 3Completed
CompareCT.gov

A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia

GlaxoSmithKline·interventional·Posted Sep 22, 2006·Updated Mar 23, 2017

In Brief

A Phase 3 clinical trial evaluating Rosiglitazone, Sulfonylurea, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 4,447 participants across 446 sites in 25 countries.

Detailed Summary

This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Romania, Russia, Slovakia, Spain, Sweden, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2006
Enrollment StartApr 1, 2001
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 19.8 years ago

Interventions

Rosiglitazonedrug

Rosiglitazone maximum 8 mg per day

Sulfonylureadrug

Sulfonylurea (SU) maximum permitted daily dose

Metformindrug

Metformin maximum permitted daily dose .