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

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 t...

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Main Authors:	Shankar, R. Ravi, Zeitler, Philip, Deeb, Asma, Jalaludin, Muhammad Yazid, 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.
Format:	Article
Published:	Wiley 2022
Subjects:	R Medicine RJ Pediatrics
Online Access:	http://eprints.um.edu.my/33637/
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spelling	my.um.eprints.336372022-07-28T04:10:01Z http://eprints.um.edu.my/33637/ A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes Shankar, R. Ravi Zeitler, Philip Deeb, Asma Jalaludin, Muhammad Yazid 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. R Medicine RJ Pediatrics 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) Wiley 2022-03 Article PeerReviewed Shankar, R. Ravi and Zeitler, Philip and Deeb, Asma and Jalaludin, Muhammad Yazid 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. (2022) A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes. Pediatric Diabetes, 23 (2). pp. 173-182. ISSN 1399-543X, DOI https://doi.org/10.1111/pedi.13279 <https://doi.org/10.1111/pedi.13279>. 10.1111/pedi.13279
institution	Universiti Malaya
building	UM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Malaya
content_source	UM Research Repository
url_provider	http://eprints.um.edu.my/
topic	R Medicine RJ Pediatrics
spellingShingle	R Medicine RJ Pediatrics Shankar, R. Ravi Zeitler, Philip Deeb, Asma Jalaludin, Muhammad Yazid 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. A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
description	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)
format	Article
author	Shankar, R. Ravi Zeitler, Philip Deeb, Asma Jalaludin, Muhammad Yazid 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.
author_facet	Shankar, R. Ravi Zeitler, Philip Deeb, Asma Jalaludin, Muhammad Yazid 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.
author_sort	Shankar, R. Ravi
title	A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
title_short	A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
title_full	A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
title_fullStr	A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
title_full_unstemmed	A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
title_sort	randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes
publisher	Wiley
publishDate	2022
url	http://eprints.um.edu.my/33637/
_version_	1739828463403008000
score	13.211869

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

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