Cargando…
Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials
AIMS/INTRODUCTION: To explore the factors associated with the glucose‐lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a post‐hoc analysis of pooled data from seven sitagliptin phase II and III clinical studies carried out...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232313/ https://www.ncbi.nlm.nih.gov/pubmed/31743602 http://dx.doi.org/10.1111/jdi.13182 |
_version_ | 1783535359179620352 |
---|---|
author | Tajima, Naoko Eiki, Jun‐ichi Okamoto, Taro Okuyama, Kotoba Kawashima, Masaru Engel, Samuel S |
author_facet | Tajima, Naoko Eiki, Jun‐ichi Okamoto, Taro Okuyama, Kotoba Kawashima, Masaru Engel, Samuel S |
author_sort | Tajima, Naoko |
collection | PubMed |
description | AIMS/INTRODUCTION: To explore the factors associated with the glucose‐lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a post‐hoc analysis of pooled data from seven sitagliptin phase II and III clinical studies carried out in Japan. All studies were double‐blind, randomized, placebo‐controlled, parallel‐group and of 12‐week duration. The analysis population consisted of 1,075 type 2 diabetes mellitus patients. In two of the trials, sitagliptin 50 mg and/or 100 mg daily were used as monotherapy; in five others, sitagliptin 50 mg daily was used as add‐on treatment to ongoing pioglitazone, glimepiride, metformin, voglibose or glinides. Efficacy (reduction in hemoglobin A1c [HbA1c]) was evaluated in 12 sets of subgroups defined by demographic, glycemic, pancreatic β‐cell function and insulin resistance parameters. An analysis of covariance model was used to evaluate the interaction between each parameter and efficacy. RESULTS: Sitagliptin consistently provided a clinically meaningful reduction in HbA1c relative to placebo across all subgroups. Within subgroups, a greater absolute HbA1c reduction was associated with higher baseline HbA1c, fasting plasma glucose and 2‐h post‐meal glucose. Lower β‐cell function, represented by homeostatic model assessment of β‐cell function and insulinogenic index, was also associated with greater HbA1c reduction. In contrast, age, sex, body mass index, duration of type 2 diabetes mellitus and insulin resistance‐related parameters did not interact with HbA1c changes. CONCLUSIONS: Sitagliptin treatment was associated with clinically meaningful improvement in glycemic control in all subgroups of Japanese patients with type 2 diabetes mellitus that were evaluated. Higher baseline glycemic status and lower baseline β‐cell function were identified as factors associated with greater HbA1c reduction after sitagliptin treatment. |
format | Online Article Text |
id | pubmed-7232313 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-72323132020-05-19 Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials Tajima, Naoko Eiki, Jun‐ichi Okamoto, Taro Okuyama, Kotoba Kawashima, Masaru Engel, Samuel S J Diabetes Investig Articles AIMS/INTRODUCTION: To explore the factors associated with the glucose‐lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This was a post‐hoc analysis of pooled data from seven sitagliptin phase II and III clinical studies carried out in Japan. All studies were double‐blind, randomized, placebo‐controlled, parallel‐group and of 12‐week duration. The analysis population consisted of 1,075 type 2 diabetes mellitus patients. In two of the trials, sitagliptin 50 mg and/or 100 mg daily were used as monotherapy; in five others, sitagliptin 50 mg daily was used as add‐on treatment to ongoing pioglitazone, glimepiride, metformin, voglibose or glinides. Efficacy (reduction in hemoglobin A1c [HbA1c]) was evaluated in 12 sets of subgroups defined by demographic, glycemic, pancreatic β‐cell function and insulin resistance parameters. An analysis of covariance model was used to evaluate the interaction between each parameter and efficacy. RESULTS: Sitagliptin consistently provided a clinically meaningful reduction in HbA1c relative to placebo across all subgroups. Within subgroups, a greater absolute HbA1c reduction was associated with higher baseline HbA1c, fasting plasma glucose and 2‐h post‐meal glucose. Lower β‐cell function, represented by homeostatic model assessment of β‐cell function and insulinogenic index, was also associated with greater HbA1c reduction. In contrast, age, sex, body mass index, duration of type 2 diabetes mellitus and insulin resistance‐related parameters did not interact with HbA1c changes. CONCLUSIONS: Sitagliptin treatment was associated with clinically meaningful improvement in glycemic control in all subgroups of Japanese patients with type 2 diabetes mellitus that were evaluated. Higher baseline glycemic status and lower baseline β‐cell function were identified as factors associated with greater HbA1c reduction after sitagliptin treatment. John Wiley and Sons Inc. 2019-12-27 2020-05 /pmc/articles/PMC7232313/ /pubmed/31743602 http://dx.doi.org/10.1111/jdi.13182 Text en © 2019 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 http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Articles Tajima, Naoko Eiki, Jun‐ichi Okamoto, Taro Okuyama, Kotoba Kawashima, Masaru Engel, Samuel S Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials |
title | Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials |
title_full | Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials |
title_fullStr | Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials |
title_full_unstemmed | Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials |
title_short | Factors associated with the glucose‐lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials |
title_sort | factors associated with the glucose‐lowering efficacy of sitagliptin in japanese patients with type 2 diabetes mellitus: pooled analysis of japanese clinical trials |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232313/ https://www.ncbi.nlm.nih.gov/pubmed/31743602 http://dx.doi.org/10.1111/jdi.13182 |
work_keys_str_mv | AT tajimanaoko factorsassociatedwiththeglucoseloweringefficacyofsitagliptininjapanesepatientswithtype2diabetesmellituspooledanalysisofjapaneseclinicaltrials AT eikijunichi factorsassociatedwiththeglucoseloweringefficacyofsitagliptininjapanesepatientswithtype2diabetesmellituspooledanalysisofjapaneseclinicaltrials AT okamototaro factorsassociatedwiththeglucoseloweringefficacyofsitagliptininjapanesepatientswithtype2diabetesmellituspooledanalysisofjapaneseclinicaltrials AT okuyamakotoba factorsassociatedwiththeglucoseloweringefficacyofsitagliptininjapanesepatientswithtype2diabetesmellituspooledanalysisofjapaneseclinicaltrials AT kawashimamasaru factorsassociatedwiththeglucoseloweringefficacyofsitagliptininjapanesepatientswithtype2diabetesmellituspooledanalysisofjapaneseclinicaltrials AT engelsamuels factorsassociatedwiththeglucoseloweringefficacyofsitagliptininjapanesepatientswithtype2diabetesmellituspooledanalysisofjapaneseclinicaltrials |