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The effect of glargine versus glimepiride on pancreatic β-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study

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Abstract

The aim of present study is to assess whether if basal insulin, glargine, could improve insulin secretory function of β-cells compared with glimepiride when metformin alone was failed. This was an open-label and multi-center study for 52 weeks in Korean patients with uncontrolled type 2 diabetes by metformin monotherapy. Subjects were randomized to glargine or glimepiride groups (n = 38 vs. 36, respectively). The primary endpoint was to compare changes in c-peptide via glucagon test after 48 weeks. Glycemic efficacy and safety endpoints (glycated hemoglobin (HbA1c), HOMA-B, fasting plasma glucose (FPG), lipid profiles, and hypoglycemic events) were also checked. The mean disease duration of all subjects was 88.2 months. Changes in C-peptide was no significant different between groups (P = 0.73), even though insulin secretion was not worsened in both groups at the endpoint. Glargine was not superior to glimepiride in other β-cell function indexes such as HOMA-B (P = 0.28). HbA1c and FPG reduced significantly in each groups but not different between two groups. Although, severe hypoglycemia did not occur, symptomatic hypoglycemia was more frequent in glimepiride group (P = 0.01). Insulin glargine was as effective as glimepiride in controlling hyperglycemia and maintaining β-cell function in Korean patients with type 2 diabetes during 48 weeks study period, after failure of metformin monotherapy. Hypoglycemic profile was favorable in the insulin glargine group and less weight gain was observed in the glimepiride group. Our results suggest that glargine and glimepiride can be considered after failure of metformin monotherapy.

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Acknowledgments

K.S.H is employed as a medical advisor of Sanofi Korea. No potential conflicts of interest relevant to this article were reported. K.S.H performed statistical analysis, and wrote and edited the manuscript. J.S.M and K.C.W contributed to the interpretation of results, and wrote and edited the manuscript. J.S.Y, H.W.L, and H.C.L contributed to discussion and reviewed the manuscript. K.C.W is the guarantor of this work and had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Conflict of interest

None.

Human and Animal Rights disclosure

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Yeungnam University College of Medicine, 170 Hyunchung-ro, Nam-gu, Daegu, 705-717, Republic of Korea

    Jun Sung Moon, Ji Sung Yoon, Hyoung Woo Lee & Kyu Chang Won

  2. Sanofi Korea, Seoul, Republic of Korea

    Kyoung Soo Ha

  3. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

    Hyun Chul Lee

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  1. Jun Sung Moon
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BETA study group

Corresponding author

Correspondence to Kyu Chang Won.

Additional information

Communicated by Massimo Porta.

Hyun Chul Lee and Kyu Chang Won are equally contributed to this manuscript as corresponding authors. This study was conducted on behalf of the ‘BETA study group’. Please refer the "Appendix" section for the BETA study group members.

ClinicalTrials.gov Identifier: NCT00562172.

Appendix: BETA study group

Appendix: BETA study group

1Bong-Soo Cha, 2Chang Won Lee, 3Choon Hee Chung, 4Chul Woo Ahn, 5Dae Jung Kim, 1Eun Seok Kang, 5Hae Jin Kim, 1Hyun Chul Lee, 6Ji Hyun Lee, 4Jong Suk Park, 5Kwan Woo Lee, 7Kyu Chang Won, 8Moonsuk Nam, 9Seok Won Park, 8Seong Bin Hong, 5Seung Jin Han, 8So Hun Kim, 9Soo Kyung Kim, 8Yong Seong Kim, 9Yong Wook Cho.

,from 1Department of Internal Medicine, Yonsei university College of Medicine, Seoul

2Department of Internal Medicine, Busan St.Mary`s Medical Center, Busan.

3Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju

4Division of Endocrinology, Department of Internal Medicine, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul

5Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon

6Department of Internal Medicine, Catholic University of Daegu, Daegu

7Department of Internal Medicine, Yeungnam University College of Medicine, Daegu

8Department of Internal Medicine, Inha University School of Medicine, Incheon

9Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea

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Moon, J.S., Ha, K.S., Yoon, J.S. et al. The effect of glargine versus glimepiride on pancreatic β-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study. Acta Diabetol 51, 277–285 (2014). https://doi.org/10.1007/s00592-013-0553-z

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