Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study—A Contemporary Prediabetes Cohort

Objective: Describe baseline characteristics of the NIH/ADA-supported D2d study, the first diabetes prevention trial in the U.S. to apply current ADA diagnostic glycemia criteria. Research Design and Methods: Multicenter (22 sites), randomized, double-blind, placebo-controlled, primary prevention trial testing efficacy of oral daily 4000 IU cholecalciferol (D 3 ) compared to placebo on incident diabetes in adults at high risk. Eligible participants met at least 2-of-3 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100-125 mg/dL, 2-hour glucose post-75g oral glucose load (2hPG) 140-199 mg/dL, and/or hemoglobin A1c (HbA1c) 5.7-6.4%. Results: 2423 participants (45% women, 33% non-white) were randomized. Mean (±SD) age was 59 (±9.9) years, and BMI was 32 (±4.5) kg/m 2 . Thirty-five percent met 3 prediabetes criteria, 49% met FPG/HbA1c criteria only, 9.5% met 2hPG/FPG criteria only, and 6.3% met 2hPG/HbA1c criteria only. Black participants had higher HbA1c and lower FPG concentration than white, Asian, and other races (P Conclusions: D2d will establish the efficacy and safety of vitamin D supplementation for diabetes prevention and inform on the natural history of prediabetes per contemporary ADA criteria. Disclosure E. LeBlanc: None. R.E. Pratley: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Eli Lilly and Company, Merck u0026 Co., Inc., Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis, Takeda Development Center Americas, Inc.. B. Dawson-Hughes: None. M.A. Staten: None. P.R. Sheehan: None. M.R. Lewis: None. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical. Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Eli Lilly and Company, Insulin Algorithms, JDRF, Lexicon Pharmaceuticals, Inc., Livongo Health. Research Support; Self; MannKind Corporation. Other Relationship; Self; Medscape. Advisory Panel; Self; Merck u0026 Co., Inc.. Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. Speaker9s Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc., Omada Health, Inc., Optum Rx, Inc., Sanofi. Research Support; Self; T1D Exchange. Advisory Panel; Self; The Endocrine Society. Research Support; Self; The Leona M. and Harry B. Helmsley Charitable Trust. Advisory Panel; Spouse/Partner; Johnson u0026 Johnson Diabetes Institute, LLC.. S.H. Kim: None. R. Chatterjee: None. V. Aroda: Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc., AstraZeneca, Calibra Medical, Eisai Inc., Sanofi. Consultant; Self; Sanofi. Research Support; Self; Theracos, Inc.. Employee; Spouse/Partner; Merck u0026 Co., Inc.. Other Relationship; Self; American Diabetes Association. Consultant; Self; ADOCIA. C. Chadha: None. A. Pittas: None.