Info

Hotel Dieu, París, France

120 men aged 25-55 years (x = 45) with borderline glucose tolerance; follow-up 2 years. Outcome: OGTT

Glibenclamide (N = 28)

Whitehall, London, UK

204 men with borderline glucose tolerance aged 40-64 years (x = 57); follow-up 5 yrs. Outcome: diabetes incidence

Warsaw, Poland

73 persons with borderline or chemical diabetes aged 23-74 (x = 54); follow-up 5 yrs. Outcome: OGTT

BIGPRO 1, France

457 subjects with high waist-hip ratio, aged

120 g/day carbohydrate Phenformin (N = 49)

50 mg/day Diet + Phenformin

Biguanide: no effect on glucose and insulin; significant weight loss. Glibenclamide: no effect on glucose and insulin; less weight loss than in other three groups

Diet: 18.2/100 worsened to diabetes. Phenformin: 18 4/100 Diet + Phenformin: 9 3/100 Placebo:

13.3/100. Phenformin vs. no phenformin: RR = 0.90 (0.45-1.8Í

(0.25-3.14)1 for worsening OGTT among all subjects vs. diet. Diet: among those with borderline tolerance only, no differences. Small, nonsignificant changes in glucose and insulin levels at 5 years in persons with borderline tolerance Metformin: —2.0 kg weight loss; less rise in F glucose and insulin; lower LDL cholesterol; tPA antigen, von

Most men would be IGT by current criteria. Double-blind. 28% dropouts, similar across groups. 14/120 subjects stopped drug for

1 month or less. No differences in weight loss (~4 kg) between placebo, G+B and B groups. 95% power to detect a 21 mg/dl drop in

2 h glucose level. Actual differences only 0-2 mg/dl. Drug not stopped for OGTT except at 2-year test, when stopped for 15 days before OGTT

Most men would have IGT by current criteria. 23/204 men dropped out (11.3%). No relation of weight change to diabetes incidence. Diabetes required 2 or more postiive tests. Drug arms were double blind. Randomization method not specified. Multiple logistic regression used to account for minor imbalances at entry

Alternate allocation, no mention of blinding. Dropouts = 33%, equal in groups. At entry, —60% had 'borderline' glucose tolerance by EASD criteria

28-30% dropout at one year. 21.5% had abnormal OGTT at entry. Assuming all persons with diabetes

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