A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes

Shankar RR 1 , Zeitler P 2 , Deeb A 3 , Jalaludin MY 4 , Garcia R 5 , Newfield RS 6 Show all authors , Samoilova Y 7 , Rosario CA 8 , Shehadeh N 9 , Saha CK 10 , Zhang Y 1 , Zilli M 1 , Scherer LW 1 , Lam RLH 1 , Golm GT 1 , Engel SS 1 , Kaufman KD 1

Affiliations 

  • 1 Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA
  • 2 Department of Endocrinology, Children's Hospital Colorado Clinical, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
  • 3 Department of Pediatric Endocrinology, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates
  • 4 Department of Paediatrics, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 5 Department of Internal Medicine and Clinical Endocrinology, Centro de Estudios Clínicos y Especialidades Medicas (CECEM), Nuevo Leon, Mexico
  • 6 Department of Pediatric Endocrinology, Rady Children's Hospital, University of California San Diego, San Diego, California, USA
  • 7 Department of Pediatric Endocrinology and Diabetology, Siberian State Medical University, Tomsk, Russia
  • 8 Department of Pediatric Endocrinology, Hospital General Plaza de la Salud, Santo Domingo, Dominican Republic
  • 9 Department of Pediatrics A and the Pediatric Diabetes Unit, Institute of Diabetes, Endocrinology, and Metabolism, Rambam Medical Center, Haifa, Israel
  • 10 Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USA
Pediatr Diabetes, 2022 Mar;23(2):173-182.
PMID: 34779087 DOI: 10.1111/pedi.13279

Abstract

OBJECTIVE: To assess the efficacy and safety of DPP-4 inhibition with sitagliptin in youth with type 2 diabetes (T2D).

STUDY DESIGN: This was a 54-week, double-blind, randomized, controlled clinical trial evaluating the safety and efficacy of DPP-4 inhibition with sitagliptin 100 mg once daily as initial oral therapy in youth with T2D. The 190 participants, aged 10-17 years, had HbA1c 6.5%-10% (7.0%-10% if on insulin). All were negative for pancreatic autoantibodies and overweight/obese at screening or diagnosis. The trial was placebo controlled for the first 20 weeks, after which metformin replaced placebo. The primary efficacy endpoint was change from baseline in HbA1c at Week 20.

RESULTS: Treatment groups were well balanced at baseline (mean ± SD HbA1c = 7.5% ± 1.0, BMI percentile = 97.1% ± 6.8, age = 14.0 years ± 2.0 [57.4% <15], 60.5% female). At Week 20, least squares mean changes from baseline in HbA1c were -0.01% (sitagliptin) and 0.18% (placebo); between-group difference (95% CI) = -0.19% (-0.68, 0.30), p = 0.448. At Week 54, the changes in HbA1c were 0.45% (sitagliptin) and -0.11 (placebo/metformin). There were no notable between-group differences in the adverse event profiles through Week 54.

CONCLUSIONS: DPP-4 inhibition with sitagliptin did not provide significant improvement in glycemic control. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01485614; EudraCT: 2011-002528-42).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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