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RECORD: Rosiglitazone Cardiovascular Outcomes Study

NCT00379769Phase 3

Key facts

Status: Completed
Start: Apr 2001
Primary completion: Dec 2008
Countries: 25
Sponsor: GSK
Modality: Small Molecules

Drugs: rosiglitazone
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 3, randomised, open-label trial of rosiglitazone in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by GSK. Primary endpoints: Cardiovascular Death or Cardiovascular Hospitalisation up to 7.5 years, Major Adverse Cardiovascular Event up to 7.5 years and 2 more. Started Apr 2001; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

Rosiglitazone + Metformin
Rosiglitazone added to background Metformin
Rosiglitazone + Sulfonylurea
Rosiglitazone added to background Sulfonylurea
Sulfonylurea + Metformin
Sulfonylurea added to background Metformin
Metformin + Sulfonylurea
Metformin added to background Sulfonylurea

Who it enrols

Patients with type 2 diabetes inadequately controlled on metformin or sulfonylurea monotherapy.

Endpoints

Primary

Cardiovascular Death or Cardiovascular Hospitalisationup to 7.5 years
Major Adverse Cardiovascular Eventup to 7.5 years
Myocardial Infarction (Fatal and Non-fatal)up to 7.5 years
Stroke (Fatal and Non-fatal)up to 7.5 years

Secondary

All-cause Deathup to 7.5 years
Glycated Haemoglobin60 months
Fasting Plasma Glucose60 months
Neoplasm/Cancer Eventsup to 11.4 years
Bone Fracture Eventsup to 11.4 years

Results

Not all primary endpoints met

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