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Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes

INTRODUCTION: We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. MATERIALS AND METHODS: A total of 467 patients with inadequate glycemic control on insuli...

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Autores principales: Shankar, R Ravi, Bao, Yuqian, Han, Ping, Hu, Ji, Ma, Jianhua, Peng, Yongde, Wu, Fan, Xu, Lei, Engel, Samuel S, Jia, Weiping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415484/
https://www.ncbi.nlm.nih.gov/pubmed/27740719
http://dx.doi.org/10.1111/jdi.12585
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author Shankar, R Ravi
Bao, Yuqian
Han, Ping
Hu, Ji
Ma, Jianhua
Peng, Yongde
Wu, Fan
Xu, Lei
Engel, Samuel S
Jia, Weiping
author_facet Shankar, R Ravi
Bao, Yuqian
Han, Ping
Hu, Ji
Ma, Jianhua
Peng, Yongde
Wu, Fan
Xu, Lei
Engel, Samuel S
Jia, Weiping
author_sort Shankar, R Ravi
collection PubMed
description INTRODUCTION: We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. MATERIALS AND METHODS: A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre‐mixed vs intermediate‐/long‐acting) at screening. The primary end‐point was the change from baseline at week 24 in HbA1c. RESULTS: The addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly (P < 0.001) reduced 2‐h post‐meal glucose by 26.5 mg/dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/dL reduction) and placebo (10.7 mg/dL reduction) groups; the between‐group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight. CONCLUSIONS: After 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus.
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spelling pubmed-54154842017-05-04 Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes Shankar, R Ravi Bao, Yuqian Han, Ping Hu, Ji Ma, Jianhua Peng, Yongde Wu, Fan Xu, Lei Engel, Samuel S Jia, Weiping J Diabetes Investig Articles INTRODUCTION: We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. MATERIALS AND METHODS: A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre‐mixed vs intermediate‐/long‐acting) at screening. The primary end‐point was the change from baseline at week 24 in HbA1c. RESULTS: The addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly (P < 0.001) reduced 2‐h post‐meal glucose by 26.5 mg/dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/dL reduction) and placebo (10.7 mg/dL reduction) groups; the between‐group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight. CONCLUSIONS: After 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus. John Wiley and Sons Inc. 2016-12-09 2017-05 /pmc/articles/PMC5415484/ /pubmed/27740719 http://dx.doi.org/10.1111/jdi.12585 Text en © 2016 Merck Sharp & Dohme Corp. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Articles
Shankar, R Ravi
Bao, Yuqian
Han, Ping
Hu, Ji
Ma, Jianhua
Peng, Yongde
Wu, Fan
Xu, Lei
Engel, Samuel S
Jia, Weiping
Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
title Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
title_full Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
title_fullStr Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
title_full_unstemmed Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
title_short Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes
title_sort sitagliptin added to stable insulin therapy with or without metformin in chinese patients with type 2 diabetes
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415484/
https://www.ncbi.nlm.nih.gov/pubmed/27740719
http://dx.doi.org/10.1111/jdi.12585
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