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Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study
INTRODUCTION: We comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes. METHODS: In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe),...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6167300/ https://www.ncbi.nlm.nih.gov/pubmed/30206903 http://dx.doi.org/10.1007/s13300-018-0505-2 |
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author | Otowa-Suematsu, Natsu Sakaguchi, Kazuhiko Nakamura, Tomoaki Hara, Kenta Kishi, Minoru Hashimoto, Naoko Yokota, Kazuki Yoshino, Hiroshi Kuroki, Yasuo Nishiumi, Tomoko Sou, Anna Komada, Hisako Okada, Yuko Hirota, Yushi Tamori, Yoshikazu Ogawa, Wataru |
author_facet | Otowa-Suematsu, Natsu Sakaguchi, Kazuhiko Nakamura, Tomoaki Hara, Kenta Kishi, Minoru Hashimoto, Naoko Yokota, Kazuki Yoshino, Hiroshi Kuroki, Yasuo Nishiumi, Tomoko Sou, Anna Komada, Hisako Okada, Yuko Hirota, Yushi Tamori, Yoshikazu Ogawa, Wataru |
author_sort | Otowa-Suematsu, Natsu |
collection | PubMed |
description | INTRODUCTION: We comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes. METHODS: In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with insulin glargine and sitagliptin. The dose of insulin glargine was titrated after the switch to maintain fasting blood glucose at approximately 110 mg/dL. The primary end points of the study were the change in glycosylated hemoglobin (HbA(1c)) level between before and 12 weeks after the treatment switch, the proportion of patients achieving an HbA(1c) level below 7.0%, and the postprandial increase in glucose concentration as assessed by self-monitoring of blood glucose. RESULTS: The change in HbA(1c) level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (− 0.6 ± 0.7% and − 0.6 ± 1.2%, respectively, P = 0.920). Neither the proportion of patients achieving an HbA(1c) level below 7.0% nor the postprandial increase in glucose concentration was different between two groups. Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively. Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia. Vildagliptin was associated with elevation of serum aspartate transaminase. Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups. CONCLUSION: The combinations of basal insulin and either lixisenatide or vildagliptin have similar efficacies with regard to improvement of glycemic control. TRIAL REGISTRATION: This trial has been registered with UMIN (No. 000010769). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-018-0505-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6167300 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-61673002018-10-08 Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study Otowa-Suematsu, Natsu Sakaguchi, Kazuhiko Nakamura, Tomoaki Hara, Kenta Kishi, Minoru Hashimoto, Naoko Yokota, Kazuki Yoshino, Hiroshi Kuroki, Yasuo Nishiumi, Tomoko Sou, Anna Komada, Hisako Okada, Yuko Hirota, Yushi Tamori, Yoshikazu Ogawa, Wataru Diabetes Ther Original Research INTRODUCTION: We comprehensively evaluated the effects of combination therapy with insulin glargine and the incretin-based drugs lixisenatide or vildagliptin in Japanese patients with type 2 diabetes. METHODS: In this 12-week, randomized, open-label, parallel-group, multicenter study (GLP-ONE Kobe), the incretin-based drug sitagliptin was randomly switched to lixisenatide (20 μg/day, n = 18) or vildagliptin (100 mg/day, n = 20) in patients with inadequate glycemic control despite combination therapy with insulin glargine and sitagliptin. The dose of insulin glargine was titrated after the switch to maintain fasting blood glucose at approximately 110 mg/dL. The primary end points of the study were the change in glycosylated hemoglobin (HbA(1c)) level between before and 12 weeks after the treatment switch, the proportion of patients achieving an HbA(1c) level below 7.0%, and the postprandial increase in glucose concentration as assessed by self-monitoring of blood glucose. RESULTS: The change in HbA(1c) level from baseline to 12 weeks did not differ significantly between the lixisenatide and vildagliptin groups (− 0.6 ± 0.7% and − 0.6 ± 1.2%, respectively, P = 0.920). Neither the proportion of patients achieving an HbA(1c) level below 7.0% nor the postprandial increase in glucose concentration was different between two groups. Body weight and serum low density lipoprotein (LDL) cholesterol level decreased significantly in the lixisenatide and vildagliptin groups, respectively. Both drugs were associated with mild gastrointestinal symptoms but not with severe hypoglycemia. Vildagliptin was associated with elevation of serum aspartate transaminase. Treatment satisfaction as assessed with the Diabetes Treatment Satisfaction Questionnaire did not differ significantly between the two groups. CONCLUSION: The combinations of basal insulin and either lixisenatide or vildagliptin have similar efficacies with regard to improvement of glycemic control. TRIAL REGISTRATION: This trial has been registered with UMIN (No. 000010769). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-018-0505-2) contains supplementary material, which is available to authorized users. Springer Healthcare 2018-09-11 2018-10 /pmc/articles/PMC6167300/ /pubmed/30206903 http://dx.doi.org/10.1007/s13300-018-0505-2 Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Otowa-Suematsu, Natsu Sakaguchi, Kazuhiko Nakamura, Tomoaki Hara, Kenta Kishi, Minoru Hashimoto, Naoko Yokota, Kazuki Yoshino, Hiroshi Kuroki, Yasuo Nishiumi, Tomoko Sou, Anna Komada, Hisako Okada, Yuko Hirota, Yushi Tamori, Yoshikazu Ogawa, Wataru Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study |
title | Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study |
title_full | Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study |
title_fullStr | Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study |
title_full_unstemmed | Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study |
title_short | Comprehensive Evaluation of Combination Therapy with Basal Insulin and Either Lixisenatide or Vildagliptin in Japanese Patients with Type 2 Diabetes: A Randomized, Open-Label, Parallel-Group, Multicenter Study |
title_sort | comprehensive evaluation of combination therapy with basal insulin and either lixisenatide or vildagliptin in japanese patients with type 2 diabetes: a randomized, open-label, parallel-group, multicenter study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6167300/ https://www.ncbi.nlm.nih.gov/pubmed/30206903 http://dx.doi.org/10.1007/s13300-018-0505-2 |
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