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

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 trea...

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Published in:Pediatric diabetes 2022-03, Vol.23 (2), p.183-193
Main Authors: Jalaludin, Muhammad Yazid, Deeb, Asma, Zeitler, Philip, Garcia, Raymundo, Newfield, Ron S., Samoilova, Yulia, Rosario, Carmen A., Shehadeh, Naim, Saha, Chandan K., Zhang, Yilong, Zilli, Martina, Scherer, Lynn W., Lam, Raymond L. H., Golm, Gregory T., Engel, Samuel S., Kaufman, Keith D., Shankar, R. Ravi
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Antidiabetics
antihyperglycemic agents
Autoantibodies
Blood Glucose - analysis
Body weight
Child
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - physiopathology
dipeptidyl peptidase‐4 inhibitor
Double-Blind Method
DPP‐4
Drug Therapy, Combination - methods
Drug Therapy, Combination - statistics & numerical data
Female
Glycated Hemoglobin A - analysis
Humans
Hypoglycemic Agents - pharmacology
Hypoglycemic Agents - therapeutic use
incretin
Insulin
Male
Metformin
Metformin - pharmacology
Metformin - therapeutic use
MK‐0431
Overweight
Patient Safety - standards
Patient Safety - statistics & numerical data
pediatric
Placebos
Safety
Sitagliptin Phosphate - pharmacology
Sitagliptin Phosphate - therapeutic use
Treatment Outcome
youth‐onset type 2 diabetes
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Summary: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% 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).
ISSN:1399-543X
1399-5448
DOI:10.1111/pedi.13282