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University Group Diabetes Program (UGDP)

  1. Genell L. Knatterud

Published Online: 15 JUL 2005

DOI: 10.1002/0470011815.b2a17152

Encyclopedia of Biostatistics

Encyclopedia of Biostatistics

How to Cite

Knatterud, G. L. 2005. University Group Diabetes Program (UGDP). Encyclopedia of Biostatistics. 8.

Author Information

  1. Maryland Medical Research Institute, Baltimore, MD, USA

Publication History

  1. Published Online: 15 JUL 2005

Abstract

The University Group Diabetes Program (UGDP) was one of the first large-scale cooperative clinical trials designed and implemented in the United States. The three objectives of the program were (1) evaluation of the effects on the development of vascular complications in adult-onset noninsulin dependent diabetes of the different hypoglycemic treatments accepted in clinical practice in late 1950s and early 1960s (diet, insulin, and oral agents); (2) study of the natural history of vascular disease in adult-onset diabetics; and (3) development of methods appropriate for the design and conduct of cooperative clinical trials.

The study provided little evidence that insulin treatment was any better than diet alone in altering the course of vascular complications in stable adult-onset diabetes. This was true whether insulin was given in a fixed dose or adjusted to maintain blood glucose within certain levels.

Tolbutamide therapy was discontinued prior to the end of follow-up for patients in the diet and insulin groups, when it became apparent that there was an excess cardiovascular mortality for patients in the tolbutamide treatment group compared to patients assigned to placebo or diet alone. About two years after the decision was made concerning tolbutamide, patients assigned to phenformin treatment were also discontinued when the observed mortality for all causes and from cardiovascular causes was higher than mortality in any of the other treatment groups.

Since the last UGDP major report was published in 1992, there has been little evidence provided to indicate benefit of therapy for the prevention of macrovascular diabetic complications in adult-onset diabetes. The methods and procedures used in the UGDP Coordinating Center provided a framework for standards of operations for future Coordinating Centers of multicenter clinical trials.

Keywords:

  • noninsulin dependent diabetes;
  • clinical trial;
  • hypoglycemic treatment