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

IF 9.3 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes Pub Date : 2026-06-11 DOI:10.2337/db26-2067-p

MEGAN O. BENSIGNOR, REBECCA FREESE, SILVA ARSLANIAN, KYLE RUDSER, AARON S. KELLY

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引用次数: 0

Abstract

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)

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2067-P：芬特明/托吡酯对青少年2型糖尿病和肥胖症患者BMI降低的影响

简介和目的：对于年轻发病的2型糖尿病（Y-T2D），一线治疗（二甲双胍±胰岛素）并不能降低肥胖的升高，而肥胖是Y-T2D的主要危险因素。目的是评估芬特明/托吡酯（PHEN/TPM）与安慰剂对Y-T2D和肥胖青少年体重指数（BMI）的影响。方法：在12-20岁的Y-T2D和肥胖青少年中进行了一项为期24周的随机安慰剂对照试验。参与者以1:1的比例随机分配到安慰剂组或PHEN/TPM组，PHEN/TPM是一种经fda批准用于治疗≥12岁肥胖青少年的口服药物。参与者开始服用PHEN/TPM，剂量为3.75 mg/23 mg，每天早上一次，每2周增加一次，8周后增加到15 mg/92 mg。在入组前接受二甲双胍±胰岛素治疗的参与者仍在使用这些药物。采用有意向治疗人群的线性回归模型比较各组间从随机分组到第24周的BMI百分比变化，并根据基线BMI进行调整。结果：随机纳入13例，平均年龄15.5±2.1岁，女性38.5%。平均基线BMI为40.3±9.57 kg/m2。24周结束时，随机分配到PHEN/TPM组的平均BMI变化为-6.4%，安慰剂组的平均BMI变化为0.3%。经基线BMI调整后，安慰剂减去BMI显著降低（-6.1;95% CI [-10.93, -1.28]; p=0.019）。结论：在这项试点试验中，与安慰剂相比，PHEN/TPM显著降低了青少年T2D糖尿病和肥胖患者的BMI。PHEN/TPM可被视为降低BMI的辅助治疗，以一线Y-T2D药物治疗青年T2D和肥胖。披露方式：研究支持；当前的;Dexcom, Inc., Vivus Inc.弗里斯：没有。S. Arslanian：没有。K. Rudser：没有。A.S. Kelly：咨询小组；当前的;勃林格殷格翰国际有限公司，礼来公司，诺和诺德。研究支持;当前的;Vivus，诺和诺德。资助NIH NIDDK （DK129721）

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来源期刊

Diabetes 医学-内分泌学与代谢

CiteScore

12.50

自引率

2.60%

发文量

1968

审稿时长

1 months

期刊介绍： Diabetes is a scientific journal that publishes original research exploring the physiological and pathophysiological aspects of diabetes mellitus. We encourage submissions of manuscripts pertaining to laboratory, animal, or human research, covering a wide range of topics. Our primary focus is on investigative reports investigating various aspects such as the development and progression of diabetes, along with its associated complications. We also welcome studies delving into normal and pathological pancreatic islet function and intermediary metabolism, as well as exploring the mechanisms of drug and hormone action from a pharmacological perspective. Additionally, we encourage submissions that delve into the biochemical and molecular aspects of both normal and abnormal biological processes. However, it is important to note that we do not publish studies relating to diabetes education or the application of accepted therapeutic and diagnostic approaches to patients with diabetes mellitus. Our aim is to provide a platform for research that contributes to advancing our understanding of the underlying mechanisms and processes of diabetes.