Jalaludin, Muhammad Yazid and Deeb, Asma and Zeitler, Philip and Garcia, Raymundo and Newfield, Ron S. and Samoilova, Yulia and Rosario, Carmen A. and Shehadeh, Naim and Saha, Chandan K. and Zhang, Yilong and Zilli, Martina and Scherer, Lynn W. and Lam, Raymond L. H. and Golm, Gregory T. and Engel, Samuel S. and Kaufman, Keith D. and Shankar, R. Ravi (2022) 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. Pediatric Diabetes, 23 (2). pp. 183-193. ISSN 1399-543X, DOI https://doi.org/10.1111/pedi.13282.
Full text not available from this repository.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/m(2), 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. (: NCT01472367, NCT01760447; EudraCT: 2011-002529-23/2014-003583-20, 2012-004035-23).
| Item Type: | Article |
|---|---|
| Funders: | Merck & Company |
| Uncontrolled Keywords: | Antihyperglycemic agents; Dipeptidyl peptidase-4 inhibitor; DPP-4; Incretin; MK-0431; Pediatric; Youth-onset type 2 diabetes |
| Subjects: | Q Science > QH Natural history > QH301 Biology Q Science > QP Physiology R Medicine > RC Internal medicine R Medicine > RJ Pediatrics |
| Divisions: | Faculty of Medicine > Paediatrics Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 28 Jul 2022 01:02 |
| Last Modified: | 28 Jul 2022 01:02 |
| URI: | http://eprints.um.edu.my/id/eprint/33641 |
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