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. 2022 Mar;23(2):183-193.
doi: 10.1111/pedi.13282. Epub 2021 Dec 20.

Efficacy and safety of the addition of sitagliptin to treatment of youth with type 2 diabetes and inadequate glycemic control on metformin without or with insulin

Muhammad Yazid Jalaludin  1 , Asma Deeb  2 , Philip Zeitler  3 , Raymundo Garcia  4 , Ron S Newfield  5 , Yulia Samoilova  6 , Carmen A Rosario  7 , Naim Shehadeh  8 , Chandan K Saha  9 , Yilong Zhang  10 , Martina Zilli  10 , Lynn W Scherer  10 , Raymond L H Lam  10 , Gregory T Golm  10 , Samuel S Engel  10 , Keith D Kaufman  10 , R Ravi Shankar  10
Affiliations

Efficacy and safety of the addition of sitagliptin to treatment of youth with type 2 diabetes and inadequate glycemic control on metformin without or with insulin

Muhammad Yazid Jalaludin et al. Pediatr Diabetes. 2022 Mar.

Abstract

Objective: To assess the efficacy and safety of sitagliptin in youth with type 2 diabetes (T2D) inadequately controlled with metformin ± insulin.

Study design: Data were pooled from two 54-week, double-blind, randomized, placebo-controlled studies of sitagliptin 100 mg daily or placebo added onto treatment of 10- to 17-year-old youth with T2D and inadequate glycemic control on metformin ± insulin. Participants (N = 220 randomized and treated) had HbA1c 6.5%-10% (7.0%-10% if on insulin), were overweight/obese at screening or diagnosis and negative for pancreatic autoantibodies. The primary endpoint was change from baseline in HbA1c at Week 20.

Results: Treatment groups were well balanced at baseline (mean HbA1c = 8.0%, BMI = 30.9 kg/m2 , age = 14.4 years [44.5% <15], 65.9% female). The dose of background metformin was >1500 mg/day for 71.8% of participants; 15.0% of participants were on insulin therapy. At Week 20, LS mean changes from baseline (95% CI) in HbA1c for sitagliptin/metformin and placebo/metformin were -0.58% (-0.94, -0.22) and -0.09% (-0.43, 0.26), respectively; difference = -0.49% (-0.90, -0.09), p = 0.018; at Week 54 the LS mean (95% CI) changes were 0.35% (-0.48, 1.19) and 0.73% (-0.08, 1.54), respectively. No meaningful differences between the adverse event profiles of the treatment groups emerged through Week 54.

Conclusions: These results do not suggest that addition of sitagliptin to metformin provides durable improvement in glycemic control in youth with T2D. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01472367, NCT01760447; EudraCT: 2011-002529-23/2014-003583-20, 2012-004035-23).

Keywords: DPP-4; MK-0431; antihyperglycemic agents; dipeptidyl peptidase-4 inhibitor; incretin; pediatric; youth-onset type 2 diabetes.

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References

REFERENCES

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