Protocol (Full-Scale Clinical Trial - Phase 3) for the Diabetes Control and Complications Trial

摘要

The protocol for the study, Diabetes Control and Complications Trial (DCCT) to compare the effects of two treatment regimens designed to produce different levels of metabolic control on the clinical course of early vascular complications in persons with insulin-dependent diabetes mellitus (IDDM). The protocol describes a randomized controlled clinical trial. Blood glucose and hemoglobin Alc will be primary indicators of metabolic control. Diabetic retinopathy will be the principal outcome assessed as will nephropathy, neuropathy and cardiovascular events or other known or putative risk factors.