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Appendix Table 3. Randomized, Controlled Trials of Interventions in Prediabetesa

Study, Year (Reference) Country Quality Rating Total Sample Size, n Mean Length of Follow-up Sample Characteristicsb Intervention Outcomes
DPP, 2000156,157, 200236, 200574,145 United States Good 3,234 2.8 y; 3.2 y for CVD outcomes Age, 51 y (10.7); 32.3% men Intensive lifestyle vs. metformin vs. placebo Cumulative incidence of T2DM: metformin, 58% lower (95% CI, 48%–66%); lifestyle, 31% lower (CI, 17%–43%) than placebo.
Cumulative incidence of CVD and CVD event rate: NSD among groups, but underpowered for this outcome.
DREAM trial, 2004 158, 2006 73,75 International; multicenter Good 5,269 Median, 3.0 y Age, 5.7 y (10.9); 40.8% men;
BMI, 30.9 kg/m2 (5.6)		 Rosiglitazone vs. placebo;
ramipril vs. placebo		 Rosiglitazone:
   Death: HR, 0.91 (CI, 0.55–1.49); P = 0.7
   T2DM incidence: HR, 0.38 (CI, 0.33– 0.44); P < 0.001
   Composite CVD outcome: HR, 0.40 (CI, 0.35–0.46); P = 0.08. Ramipril:
   Death: HR, 0.98 (CI, 0.60–1.60)
   T2DM incidence: HR, 0.91 (CI, 0.80– 1.03)
   Composite CVD outcome: HR, 0.91 (CI, 0.81–1.03); P = 0.68.
Finnish Diabetes Prevention Study, 1999161, 200176, 2003141, 2003159, 2005160, 200682 Finland Fair 522 3.2 y for postintervention outcomes; median total follow-up, 7 y Age, 55 y (7); 32.9% men Lifestyle vs. usual care Cumulative incidence of T2DM:
   At 3.2 y: HR, 0.4 (CI, 0.3–0.7); P < 0.001
   At 7 y: HR, 0.57 (CI, 0.43–0.76); P < 0.001.
Indian Diabetes Prevention Programme, 200677 India Fair 531 Median, 2.5 y Age, 54.9 y (5.7); 79.0% men Lifestyle and metformin vs. lifestyle vs. metformin vs. placebo Relative risk reduction in incidence of T2DM at year 3:
   Lifestyle: 28.5% (CI, 20.5%–37.3%)
   Metformin: 26.4% (CI, 19.1%–35.1%)
   Lifestyle and metformin: 28.2% (CI, 20.3%–37.0%).
Watanabe et al., 200378 Japan Fair 173 1.0 y Age, 55.1 y (7.1); 100% men Dietary counseling vs. usual care T2DM incidence: NSD between groups (data not provided).
Pan et al., 200384 China Fair 261 16 wk Age, 54.5 y (8.5); 40.0% men Acarbose vs. placebo T2DM incidence: acarbose, 5.6%; placebo, 9.5%; P = 0.245.
Kosaka et al., 200538 Japan Fair 458 4.0 y Age, NR; 100% men Lifestyle vs. usual care Cumulative incidence T2DM over 4 y: lifestyle, 3%; control, 9.3%; P = 0.043 between groups.
Heymsfield et al., 200037 International; multicenter Fair to poor 675 2.0 y Age, 43.9 y; 17.5% men Orlistat vs. placebo; both received lifestyle intervention IGT at baseline and at follow-up:
   Normoglycemia: orlistat, 71.6%; placebo, 49.1%
   IGT: orlistat, 25.4%; placebo, 43.4%
   T2DM: orlistat, 3.0%; placebo, 7.6%
P = 0.04 between groups.
STOP-NIDDM trial, 1998163, 200272, 2003162 International; multicenter Fair 1,429 3.3 y Age, 54.5 y (7.9); 49% men Acarbose vs. placebo; both received lifestyle intervention Cumulative incidence of:
   T2DM: HR, 0.75 (CI, 0.63–0.90); P = 0.0015
   Any CVD event: HR, 0.51 (CI, 0.28–0.95); P = 0.02
   MI: HR, 0.09 (CI, 0.01–0.72); P = 0.02.
Swinburn et al., 200179 New Zealand Fair to poor 136 5.0 y Age, 52.2 y (6.5); 50.7% men Reduced-fat diet vs. usual diet Intervention was associated with a lower proportion of persons with T2DM or IGT at 1 y (P < 0.05); NSD at 2, 3, or 5 y.
Included population all had IGT at recruitment, but only 31% had prediabetes with repeated testing at randomization; results are for all included patients.
XENDOS study, 2001 (164), 200483 Sweden Fair to poor 3305 total (694 with IGT) 4.0 y Age, 43.8 y (8.0); 44.8% men; BMI, 37.3 kg/m2 (4.3) Orlistat vs. placebo; both received lifestyle intervention Cumulative incidence of T2DM in IGT subgroup after 4 y: HR, 0.551; P = 0.0024.

a  BMI = body mass index; CVD = cardiovascular disease; DPP = Diabetes Prevention Program; DREAM = Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication; HR = hazard ratio; IGT = impaired glucose tolerance; MI = myocardial infarction; NSD = no significant difference; OGTT = oral glucose tolerance test; STOP-NIDDM = Study to Prevent Non–Insulin-Dependent Diabetes Mellitus; T2DM = type 2 diabetes mellitus; XENDOS = Xenical in the Prevention of Diabetes in Obese Subjects.
b  Data are reported as means (SDs), unless otherwise noted.

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