Belknap et al.
Cam er ini- Da valos
Feldman et al. 1967,
Seattle, WA, USA
34 men aged 33-75 (x = 57 years) with abnormal IV and OGTT; randomized cross-over design; follow-up 1 yr on each arm, 2 yrs total. Outcome: F glucose, IVGTT Humble Oil Co.
employees, Houston, TX, USA
42 persons aged 25-67 (x = 47) years with IGT by old criteria; follow-up 14 months. Outcome: OGTT
New York, NY, USA
97 subjects with chemical diabetes aged 15-44 (x= 34 years); follow-up 10-24 months. Outcome: OGTT
Kaiser Permanente, Oakland, CA
350 subjects aged 15-59 from screening, with chemical diabetes; follow-up 5 yrs. Outcome: diabetes incidence
Tolbutamide (N = 34) 500
mgbid Placebo (N = 34) crossover design
Tolbutamide (N = 20)
Tolbutamide (N = 38)
Tolbutamide (N = 174) 500
mgbid Phenformin (N = 91)
Tolbutamide: diabetes incidence not reported; fasting glucose showed no increase on drug ( + 1 mg/dl), significantly different than placebo at end (p <0.01); no weight loss, no effect on lipids; IVGT said to improve, but data not shown. Placebo: fasting glucose increased +6 mg/dl; no weight change
Tolbutamide: Lower 1 h post-load glucose levels (—36.4 mg/dl, —2.0 mM/L); no differences in 2 h or 3 h levels at 14 months. No report of diabetes incidence. Essentially negative
Tolbutamide: RR = 0 73 (0 45-1 18, p = 0.25 intent to treat, ARR = 14/100 PY)1 for impaired OGTT at follow-up; no weight change; triglycerides increased (p <0.01). Placebo: similar improvement in glucose levels on OGTT Tolbutamide: 0.6/100 PY diabetes at 5 years RR = 0.16 (0.02-1.54, p = 0.20, ARR = 2.9/100 PY)1 vs placebo. Phenformin: 0/100 PY diabetes (p = 0.22) vs. placebo. Placebo: 3.5/100 PY diabetes
Dropouts = 21%; order of randomization masked, double-blind. Very limited data presented; drug may have had effect by limiting increase in glucose levels. Drug stopped 12 hours before test
23-25% drop-out at one year. No changes in weight, though placebo group was 8.2 lbs (3.7 kg) heavier at randomization. Allocation not masked, results were blinded. Considered patients to be asymptomatic diabetics, though most would be IGT by current criteria. Drug stopped for 12 hrs before test No randomization or allocation method noted, no blinding, variable follow-up duration across groups, no multivariate analysis. Drug stopped for 3 days before test
Most would have IGT by current criteria; double-blind; dropouts 22%. Greatest declines in 2 h glucose for tolbutamide, although placebo decreases were almost as great, and both returned to baseline by 42 months. Phenformin had no lowering of 2 h glucose levels. Drug stopped for 3 days prior to testing
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