drugset / Trial / NCT00145925

Blood Pressure and Glucose Lowering for the Prevention of Vascular Disease in High Risk Patients With Type 2 Diabetes

Phase 3 Completed 11140 enrolled The George Institute Institut de Recherches Internationales Servier · collab National Health and Medical Research Council, Australia · collab University of Sydney · collab

RandomizedFactorialDouble-blindPrevention

Summary

The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a result of cardiovascular disease), as well as new or worsening diabetic eye and kidney disease.

Timeline

Start: 2001-06
Primary completion: 2008-03
Completion: 2008-03

Outcome

Mixed primary results

paper Intensive control reduced the incidence of combined major macrovascular and microvascular events (18.1%, vs. 20.0% with standard control; hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P=0.01) PMID 18539916 ↗

paper There were no significant effects of the type of glucose control on major macrovascular events (hazard ratio with intensive control, 0.94; 95% CI, 0.84 to 1.06; P=0.32) PMID 18539916 ↗

paper The relative risk of a major macrovascular or microvascular event was reduced by 9% (861 [15.5%] active vs 938 [16.8%] placebo; hazard ratio 0.91, 95% CI 0.83-1.00, p=0.04). PMID 17765963 ↗

paper The separate reductions in macrovascular and microvascular events were similar but were not independently significant (macrovascular 0.92; 0.81-1.04, p=0.16; microvascular 0.91; 0.80-1.04, p=0.16). PMID 17765963 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gliclazide	Small molecule	—	—
Comparator	Indapamide	Small molecule	1.25 mg	—
Comparator	Perindopril	Small molecule	4 mg	—