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RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

NCT00379769 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4447

Last updated 2017-03-23

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Rosiglitazone

Rosiglitazone maximum 8 mg per day

DRUG

Sulfonylurea

Sulfonylurea (SU) maximum permitted daily dose

DRUG

Metformin

Metformin maximum permitted daily dose .

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Australia
  • 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

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379769 on ClinicalTrials.gov