Status:
COMPLETED
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief 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 co...
Detailed Description
A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).
Eligibility Criteria
Inclusion
- Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
- Glycated haemoglobin (HbA1c) \>7.0 % to = 9.0 % at visit 1.
- Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
- Body mass index \>25.0 kg/m2.
Exclusion
- Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
- Patients with systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg.
- Patients who have required the use of insulin for glycaemic control at any time in the past.
- Hospitalisation for any major cardiovascular event in the last 3 months.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
4447 Patients enrolled
Trial Details
Trial ID
NCT00379769
Start Date
April 1 2001
End Date
December 1 2008
Last Update
March 23 2017
Active Locations (446)
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1
GSK Investigational Site
Miranda, New South Wales, Australia, 2228
2
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
3
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
4
GSK Investigational Site
Carina Heights, Queensland, Australia, 4152