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A correction has been published: N Engl J Med 2009;361(10):1028.

Previous Volume 360:129-139 January 8, 2009 Number 2 Next

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ABSTRACT

Background The effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain.

Methods We randomly assigned 1791 military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard-therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene.

Results The median follow-up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard-therapy group and 6.9% in the intensive-therapy group. The primary outcome occurred in 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group (hazard ratio in the intensive-therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P=0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause (hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P=0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group.

Conclusions Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications, with the exception of progression of albuminuria (P = 0.01). (ClinicalTrials.gov number, NCT00032487 [ClinicalTrials.gov] .)

Source Information

From the Phoenix Veterans Affairs (VA) Health Care Center, Phoenix, AZ (W.D., P.D.R.); Miami VA Medical Center, Miami (C.A., J.M.); Hines VA Cooperative Studies Program Coordinating Center (T.M., D.R., M.M., M.E.V., W.G.H.) and Hines VA Hospital (N.E.) — both in Hines, IL; Hunter Holmes McGuire VA Medical Center, Richmond, VA (F.J.Z.); Tennessee Valley Health Care System, Nashville (S.N.D.); VA Ann Arbor Healthcare System, Ann Arbor, MI (R.H.); VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W.); Southern Arizona VA Health Care System, Tucson (S.G.); and the Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC (G.D.H.).

This article (10.1056/NEJMoa0808431) was published on December 17, 2008, and was last updated on September 2, 2009, at NEJM.org.

Address reprint requests to Dr. Duckworth at the Phoenix VA Health Care System, 650 E. Indian School Rd., Phoenix, AZ 85012, or at william.duckworth{at}va.gov.

Full Text of this Article

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