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Diabetes Ther. 2018 Oct;9(5):2067-2079. doi: 10.1007/s13300-018-0505-2. Epub 2018 Sep 11.

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.

Diabetes therapy : research, treatment and education of diabetes and related disorders

Natsu Otowa-Suematsu, Kazuhiko Sakaguchi, Tomoaki Nakamura, Kenta Hara, Minoru Kishi, Naoko Hashimoto, Kazuki Yokota, Hiroshi Yoshino, Yasuo Kuroki, Tomoko Nishiumi, Anna Sou, Hisako Komada, Yuko Okada, Yushi Hirota, Yoshikazu Tamori, Wataru Ogawa

Affiliations

  1. Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
  2. Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. [email protected].
  3. Division of General Internal Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. [email protected].
  4. Department of Diabetes and Endocrine disease, Kita-harima Medical Center, Ono, Japan.
  5. Department of Internal Medicine, Nishiwaki Municipal Hospital, Nishiwaki, Japan.
  6. Department of Diabetes and Endocrinology, Hyogo Brain and Heart Center, Himeji, Japan.
  7. Department of Internal Medicine, Jinkeikai Ishii Hospital, Akashi, Japan.
  8. Department of Internal Medicine, Shinsuma General Hospital, Kobe, Japan.
  9. Department of Internal Medicine, Kobe Century Memorial Hospital, Kobe, Japan.
  10. Department of Diabetes and Endocrinology, Kobe Rosai Hospital, Kobe, Japan.
  11. Division of Creative Health Promotion, Department of Social/Community Medicine and Health Science, Kobe University Graduate School of Medicine, Kobe, Japan.

PMID: 30206903 PMCID: PMC6167300 DOI: 10.1007/s13300-018-0505-2

Abstract

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

RESULTS: The change in HbA

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).

Keywords: Insulin glargine; Lixisenatide; Vildagliptin

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