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1 BETA-CELL FAILURE IN DIABETES AND PRESERVATION BY ...

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37<br />

Diabetes Prevention Program (DPP)<br />

The Diabetes Prevention Program (DPP) was a randomized clinical trial of prevention<br />

of type 2 diabetes in people at high risk of diabetes (153). From 1996 to 1998, 3,324 adults<br />

with IGT and fasting plasma glucose from 100 to 140 mg/dl before June 1997 and from 95<br />

to 125 mg/dl after this date,were randomized to receive placebo (n=582), metformin<br />

(n=587), troglitazone (n=585) or intensive lifestyle intervention (n=589). The incidence of<br />

diabetes during an average follow-up of 2.8 years, when the study was interrupted stood at<br />

11.0, 7.8 and 4.8 cases per 100 person-years in the placebo, metformin and lifestyle change<br />

groups, respectively.The incidence of diabetes was reduced by 58% in the lifestyle group<br />

and by 31% in the metformin group relative to standard lifestyle intervention (placebo).<br />

Over concern regarding its liver toxicity, the troglitazone arm was discontinued in June<br />

1998 after 0.5–1.5 years (mean 0.9 year) and then compared with other DPP interventions,<br />

considering both the short-term “in-trial” results and the longer-term results after<br />

troglitazone was discontinued. During the mean 0.9 year of troglitazone treatment, the<br />

diabetes incidence rate was 3.0 cases /100 person-years, compared with 12.0, 6.7 and 5.1<br />

cases/100 person-years in the placebo, metformin and intensive lifestyle participants<br />

(p

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