Clinical Trial of the Use of Sitagliptin in Pediatric Patients with T2D: Baseline Characteristics

MK-0431-P083, a multinational, 54-week, phase III study of the DPP-4 inhibitor sitagliptin (SITA) as initial oral therapy in patients 10-17 years of age with T2D, was initiated in 2012 and completed enrollment in 2018. A total of 201 patients with T2D who were either drug-naïve or on insulin alone at study entry were randomized and treated. Baseline characteristics of this population were summarized in a preliminary analysis and are presented below. Mean age was 14.0 ± 2.0 years, ∼58% were <15 years of age, and ∼61% were female. The majority (∼53%) were White, 14.9% were Asian, 5.5% were Black, and ∼19% were multiracial, with ∼37% describing themselves as Hispanic. The mean duration of diabetes was 0.7 ± 1.2 years, with ∼17% of participants having a duration ≥1 year. Approximately 11% of participants were on insulin at study entry. Mean BMI was 32.2 ± 7.7 kg.m-2, mean waist circumference was 100.9 ± 17.5 cm, and mean systolic and diastolic BP were 115.5 ± 10.6 mm Hg and 70.5 ± 8.5 mm Hg, respectively. Mean A1C was 7.5 ± 1.0%, and mean FPG 138.3 ± 45.2 mg/dL. Mean triglycerides were 137.4 ± 73.8 mg/dL and mean eGFR (calculated using the MDRD formula) was 200.4 ± 61.1 mL.min-1/1.73 m2. Mean ALT and AST levels were 27.3 ± 18.4 IU/L and 21.6 ± 9.8 IU/L, respectively. Among females, ∼71% had Tanner IV-V breast development, and among males, ∼63% had Tanner IV-V testicular development. These baseline data show that most participants in this study were drug-naïve, with a relatively short duration of T2D, and were predominantly female, White, and sexually mature. They were significantly obese, with central adiposity. Except for race, the demographic and anthropometric characteristics and the A1C and FPG of the participants in this global study are consistent with previous reports of patients predominantly from the United States. In addition, these baseline data confirm reports of glomerular hyperfiltration in pediatric patients with T2D. Disclosure M.Y. Jalaludin: Advisory Panel; Self; Novo Nordisk Inc. Research Support; Self; Merck Sharp & Dohme Corp., Novo Nordisk Inc. R. Garcia: None. R.S. Newfield: Research Support; Self; Bristol-Myers Squibb Company, Daiichi Sankyo Company, Limited, Eli Lilly and Company, University of California and Rady Children's Hospital, San Diego. C.A. Rosario: None. Y. Samoilova: None. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. Y. Zhang: Employee; Self; Merck Sharp & Dohme Corp. L.W. Scherer: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. C.K. Saha: Research Support; Self; Indiana University School of Medicine. S.S. Engel: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Research & Development, Merck & Co., Inc., Novo Nordisk Inc. K.D. Kaufman: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. R. Shankar: Employee; Spouse/Partner; AstraZeneca. Employee; Self; Merck & Co., Inc. Employee; Spouse/Partner; NGM Biopharmaceuticals. Funding Merck & Co., Inc.