Long-Term Efficacy and Safety of Add-On Therapy of Sitagliptin to a Very Small Dose of Glimepiride Versus a Small Dose of Glimepiride Over Eighteen Months

Masako Hatano, Ikuo Inoue, Susumu Kurihara, Hiraku Ono, Masafumi Matsuda, Masafumi Kakei, Toshihiko Inukai, Yoshimasa Aso, Shigehiro Katayama


Background: In patients associated with type 2 diabetes mellitus, sulfonylureas (SUs) are being prescribed less frequently, and in smaller doses, to avoid hypoglycemia and body weight gain. On the other hand, since dipeptidyl peptidase-4 (DPP-4) inhibitors only infrequently induce hypoglycemia and weight gain, more than 60% or 70% of Japanese patients associated with type 2 diabetes mellitus are currently being treated with DPP-4 inhibitors. However, the long-term effects of DPP-4 inhibitors on glycemic control and beta-cell function have not been thoroughly elucidated.

Methods: The present study was designed to compare the long-term efficacy and safety of a daily administration of 50 mg sitagliptin added to a very small dose of glimepiride, SUs, of 1.1 mg (SIT group), versus a small dose of glimepiride added by 1 mg to its basal dosage, i.e., 2.1 mg (SU group) up to 18 months in Japanese patients with type 2 diabetes mellitus. Sixty patients, aged 20 to 75 years with hemoglobin A1c (HbA1c) between 7.4% and 9.0% on glimepiride with or without metformin, were randomized into two groups. If the target (HbA1c is less and equall than 6.9% or fasting plasma glucose levelis less and equall than 130 mg/dL) was not achieved, sitagliptin or glimepiride, respectively, was increased.

Results: After 18 months, HbA1c had significantly decreased to 7.1-7.2% in both groups (P < 0.01). Plasma levels of insulin and proinsulin remained unchanged during the study. However, the proinsulin/insulin ratio was significantly lower after 6 months and thereafter only in the SU group. Homeostasis model assessment-beta cell (HOMA-beta) demonstrated a significant augmentation at some points during the study in both groups. No severe hypoglycemic episodes or body weight gain were seen in either group.

Conclusions: Add-on therapy of 50 mg of sitagliptin to a very small dose of glimepiride at 1.1 to 1.2 mg/day, or a small dose of glimepiride at 2.1 mg/day, proved effective for improving or maintaining glycemic control without deterioration of beta-cell function over 18 months.

J Endocrinol Metab. 2019;9(6):171-179
doi: https://doi.org/10.14740/jem621


Type 2 diabetes mellitus; DPP-4 inhibitor; Sulfonylurea; beta-cell function

Full Text: HTML PDF

Browse  Journals  


Journal of Clinical Medicine Research

Journal of Endocrinology and Metabolism

Journal of Clinical Gynecology and Obstetrics


World Journal of Oncology

Gastroenterology Research

Journal of Hematology


Journal of Medical Cases

Journal of Current Surgery

Clinical Infection and Immunity


Cardiology Research

World Journal of Nephrology and Urology

Cellular and Molecular Medicine Research


Journal of Neurology Research

International Journal of Clinical Pediatrics



Journal of Endocrinology and Metabolism, bimonthly, ISSN 1923-2861 (print), 1923-287X (online), published by Elmer Press Inc.                     
The content of this site is intended for health care professionals.
This is an open-access journal distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits unrestricted
non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Creative Commons Attribution license (Attribution-NonCommercial 4.0 International CC-BY-NC 4.0)

This journal follows the International Committee of Medical Journal Editors (ICMJE) recommendations for manuscripts submitted to biomedical journals,
the Committee on Publication Ethics (COPE) guidelines, and the Principles of Transparency and Best Practice in Scholarly Publishing.

website: www.jofem.org   editorial contact: editor@jofem.org
Address: 9225 Leslie Street, Suite 201, Richmond Hill, Ontario, L4B 3H6, Canada

© Elmer Press Inc. All Rights Reserved.

Disclaimer: The views and opinions expressed in the published articles are those of the authors and do not necessarily reflect the views or opinions of the editors and Elmer Press Inc. This website is provided for medical research and informational purposes only and does not constitute any medical advice or professional services. The information provided in this journal should not be used for diagnosis and treatment, those seeking medical advice should always consult with a licensed physician.