Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)

Phase 3 Completed 200 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment.

Timeline

Start: 2012-02-10
Primary completion: 2019-10-09
Completion: 2019-10-09

Outcome

Missed primary endpoint

paper DPP-4 inhibition with sitagliptin did not provide significant improvement in glycemic control. PMID 34779087 ↗

registry analysis (superiority test); Sitagliptin vs Placebo (Pooled); p = 0.448; Least Squares Means Difference -0.19 (95% CI -0.68 to 0.30); Mixed Models Analysis NCT01485614 ↗

Publications

Shankar RR, Zeitler P, Deeb A, Jalaludin MY, Garcia R, Newfield RS, Samoilova Y, Rosario CA, Shehadeh N, Saha CK, Zhang Y, Zilli M, Scherer LW, Lam RLH, Golm GT, Engel SS, Kaufman KD. A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes. Pediatr Diabetes. 2022 Mar;23(2):173-182. doi: 10.1111/pedi.13279. Epub 2021 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Metformin	Small molecule	1000 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Insulin	Protein / enzyme biologic	—	—