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Table 2 Characteristics of high quality clinical trials identified (adapted from[37, 38])

From: Cardiac implications of hypoglycaemia in patients with diabetes – a systematic review

Study Population Design Treatments Outcome
DCCT/EDIC [39, 40] 1,441 T1D adolescents and adults (13–39 years old) with diabetes duration of 1–15 years Effect of intensive vs. conventional treatment on micro- and macrovascular complications Intensive treatment (multiple injections or pump) vs. standard therapy ↓CVD by 54%, but only evident after long-term (>12-yr.) follow-up
UKPDS [41, 42] 5,102 newly diagnosed T2D adults Randomized control trial of intensive therapy to reduce complications of T2D Two intensive treatment arms (insulin/sulfonylurea or metformin) vs. conventional therapy No significant differences in CV outcomes after trial, but 10-yr. follow-up revealed a modest reduction in CVD
ACCORD [8, 43, 44] 10,251 T2D patients, 40–79 years of age with CV or 55–79 years of age with atherosclerosis or ≥ two risk factors 3.5 yr. study; Randomized control trial of excellent HbA1c (<6%) vs. 7.0–7.9% Combinations of all available treatments to achieve goal HbA1c Study stopped early because of increased overall and CV mortality; primary CVD endpoint ↓10% (P=0.16); overall mortality ↑22% (P=0.04); CV mortality ↑35% (P=0.02)
ADVANCE [9] 11,140 patients with T2D in 20 countries, ≥55 years of age and ≥30 years of age at diagnosis 5 yr. study; tested if glucose lowering affected CV risk in T2D patients with at least one risk factor Intensive glucose lowering (≤6.5%) vs. standard treatment No difference in CV end point by treatment group; primary CVD endpoint ↓6% (P=0.37); overall mortality ↓7% (P=NS); CV mortality ↓12% (P=NS)
VADT [10, 45, 46] 1,791 patients with T2D on insulin or maximal-dose oral agents 5.6 yr. study; determined effect of intensive glycaemic control on CV risk Intensive treatment (<6.0%) vs. standard treatment No difference in CV end point by treatment group; primary CVD endpoint ↓13% (P=0.12); overall mortality ↑6.5% (P=NS); CV mortality ↑25% (P=NS)
ORIGIN [47] 12,537 patients with IFG, IGT or T2D on insulin glargine or standard of care 6.2 yr study; determined effect of early insulin treatment on CV events Insulin glargine vs. standard of care No differences in the rate of CV events (P=0.63/0.27)
  1. ACCORD Action to Control Cardiovascular Risk in Diabetes, ADVANCE Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, CVD, cardiovascular disease, DCCT Diabetes Control and Complications Trial, EDIC Epidemiology of Diabetes Interventions and Complications, HbA1c glycosylated haemoglobin, IFG impaired fasting glucose, IGT impaired glucose tolerance, ORIGIN Outcome Reduction with Initial Glargine Intervention, T1D type 1 diabetes, T2D type 2 diabetes, UKPDS United Kingdom Prospective Diabetes Study.