2067-P: Effect of Phentermine/Topiramate on BMI Reduction in Adolescents with Youth-Onset Type 2 Diabetes and Obesity

Introduction and Objective: First-line treatment (metformin ± insulin) for youth-onset type 2 diabetes (Y-T2D) does not reduce elevated adiposity, a primary risk factors for Y-T2D. The objective was to evaluate the effects of phentermine/topiramate (PHEN/TPM) versus placebo on body mass index (BMI) in adolescents with Y-T2D and obesity. Methods: A pilot, randomized 24-week placebo-controlled trial in adolescents, aged 12-20 years, with Y-T2D and obesity was conducted. Participants were randomized 1:1 to placebo or PHEN/TPM, a oral medication FDA-approved for youth ≥ 12 years with obesity. Participants initiated PHEN/TPM at 3.75 mg/23 mg once daily in the morning and increased every 2 weeks to a dose of 15 mg/92 mg after 8 weeks. Participants who were on metformin ± insulin therapy prior to enrollment remained on these medications. Linear regression model with an intent-to-treat population was used to compare the BMI percent change from randomization to week 24 between the groups, adjusted for baseline BMI. Results: Thirteen participants (mean age 15.5 ± 2.1 years, 38.5% female) were randomized. Mean baseline BMI was 40.3 ± 9.57 kg/m2. At the end of 24 weeks, the mean BMI change was -6.4% for those randomized to PHEN/TPM and 0.3% for the placebo group. When adjusted for baseline BMI, the placebo-subtracted BMI reduction was significant (-6.1; 95% CI [-10.93, -1.28]; p=0.019). Conclusion: In this pilot trial, PHEN/TPM significantly reduced BMI in adolescents with T2D diabetes and obesity compared with placebo. PHEN/TPM may be considered as adjuvant therapy for BMI reduction to first-line Y-T2D medications in youth with T2D and obesity. Disclosure M.O. Bensignor: Research Support; Current; Dexcom, Inc., Vivus Inc. R. Freese: None. S. Arslanian: None. K. Rudser: None. A.S. Kelly: Advisory Panel; Current; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk. Research Support; Current; Vivus, Novo Nordisk. Funding NIH NIDDK (DK129721)