Table 3.
Key baseline characteristics of D2d versus other large prediabetes trials
| D2d | SCALE | NAVIGATOR | DREAM | DPP | STOP-NIDDM | ACE | |
|---|---|---|---|---|---|---|---|
| N | 2,423 | 2,254 | 9,518 | 5,269 | 3,234 | 1,429 | 6,522 |
| Years conducted (country) | 2013–2018 (estimated) (U.S.) | 2011–2015 (multiple countries worldwide)1 | 2002–2007 (multiple countries worldwide)1 | 2001–2006 (multiple countries worldwide) | 1996–2001 (U.S.)1 | 1995–2000 (multiple countries worldwide)1 | 2009–2015 (China) |
| Study design and intervention | Two arms: vitamin D3 vs. placebo | Two arms: liraglutide vs. placebo (2:1 ratio) | 2 × 2 factorial design: nateglinide and/or valsartan vs. placebos | 2 × 2 factorial design: ramipril and/or rosiglitazone vs. placebos | Three arms: metformin vs. intensive lifestyle vs. placebo | Two arms: acarbose vs. placebo | Two arms: acarbose vs. placebo |
| Glycemic criteria | At least two of three 2010 ADA criteria for prediabetes: 2hPG 140–199 mg/dL, FPG 100–125 mg/dL, HbA1c 5.7–6.4% | At least one of three 2010 ADA criteria for prediabetes: 2hPG 140–199 mg/dL, FPG 100–125 mg/dL, HbA1c 5.7–6.4% | 2hPG 140–199 mg/dL and FPG 95–125 mg/dL | 2hPG 140–199 mg/dL or FPG 110–125 mg/dL | 2hPG 140–199 mg/dL and FPG 95–125 mg/dL | 2hPG 140–199 mg/dL and FPG 101–139 mg/dL | 2hPG 140–199 mg/dL |
| Age, years, mean | 60.0 | 47.4 | 63.8 | 54.7 | 50.6 | 54.5 | 64.3 |
| Women, % | 45 | 76 | 51 | 59 | 68 | 51 | 27 |
| BMI, kg/m2, mean | 32.1 | 38.9 | 30.5 | 30.9 | 34.0 | 31 | 25.4 |
| Waist circumference, cm, mean | 105.0 | 116.6 | 101 | Not reported | 105.1 | 101 | 91.2 |
| White race, % | 66.7 | 83 | 83.1 | Not reported | 552 | 98 | 0 |
| Family history of diabetes, % | 62.5 | Not reported | 38 | Not reported | 69 | Not reported | Not reported |
| FPG, mg/dL, mean | 107.9 | 99.0 | 109.6 | 104.4 | 106.5 | 112.0 | 99.0 |
| 2hPG, mg/dL, mean | 137.25 | 133.2 | 164.9 | 156.6 | 164.6 | 166.7 | 167.4 |
| HbA1c, %, mean | 5.9 | 5.8 | 5.8 | Not reported | 5.9 | Not reported | 5.9 |
| Duration of follow-up, years, mean | 3 (estimated) | 3.0 | 5.0 | 3.0 | 2.8 | 3.3 | 5.0 |
| Cumulative incidence of diabetes in placebo group during mean follow-up, % | Not available | 11 | 34 | 19 | 29 | 42 | 15 |
Trials selected for having >1,000 participants and at least 1 year of follow-up. DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication; NAVIGATOR, Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research; STOP-NIDDM, Study to Prevent Non-Insulin-Dependent Diabetes Mellitus.
1Study duration was estimated based on published information about the end of recruitment and follow-up time.
2Non-Hispanic white.