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Diabetes Ther. 2019 May 11. doi: 10.1007/s13300-019-0628-0. [Epub ahead of print]

Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: A 12-Week Interim Report.

Author information

1
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
2
Department of Family Medicine, University of Ulsan College of Medicine, Seoul, Korea.
3
Department of Internal Medicne, Hanyang University College of Medicine, Guri, Korea.
4
Department of Internal Medicine, College of Medicine, Hallym University, Chuncheon, Korea.
5
Department of Cardiology, Yonsei University College of Medicine, Seoul, Korea.
6
Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.
7
Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea.
8
Department of Internal Medicine, Seoul Medical center, Seoul, Korea.
9
Department of Internal Medicine, Catholic University of Daegu, Korea, Daegu, Korea.
10
Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
11
Medical Affairs, Handok Inc, Seoul, Korea.
12
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea. lkw65@ajou.ac.kr.

Abstract

INTRODUCTION:

Teneligliptin, an antidiabetic agent classified as a class III dipeptidyl peptidase-4 (DPP-4) inhibitor, has a unique structural feature that provides strong binding to DPP-4 enzymes. We investigated the efficacy and safety of switching patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control on a stable dose of other DPP-4 inhibitors to teneligliptin.

METHODS:

Patients with T2DM whose glycosylated hemoglobin (HbA1c) levels were ≥ 7% despite taking DPP-4 inhibitors other than teneligliptin, with or without other hypoglycemic agents, for at least 3 months were enrolled. The DPP-4 inhibitors taken before participating in the study were switched to 20 mg qd teneligliptin, and this was to be maintained for 52 weeks. The primary end point was the change in HbA1c levels after 12 weeks. Metabolic parameters including fasting plasma glucose (FPG) and blood lipids were assessed also. To assess safety, adverse and hypoglycemic events were monitored. The data from baseline to week 12 were used for analysis in this interim report.

RESULTS:

The mean change in HbA1c levels from baseline to week 12 was - 0.44%. At week 12, the percentage of patients achieving HbA1c < 7.0% was 31.6% and that of achieving HbA1c < 6.5% was 11.4%, respectively. In 41.2% of patients, the HbA1c levels decreased by at least 0.5% at 12 weeks. The mean change in FPG levels from baseline to week 12 was - 11.5 mg/dl. No severe hypoglycemia was reported.

CONCLUSION:

After switching to teneligliptin, HbA1c levels decreased significantly in patients with T2DM inadequately controlled with other DPP-4 inhibitors.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT03793023.

FUNDING:

Handok Inc.

KEYWORDS:

Diabetes mellitus, Type 2; Dipeptidyl-peptidase IV inhibitors; Teneligliptin

PMID:
31079357
DOI:
10.1007/s13300-019-0628-0

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