Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

Observational Study to Evaluate the Efficacy and Safety of Teneligliptin When Switched From Other DPP-4 Inhibitors in Type 2 DM With Inadequate Glycemic Control

This study is designed as a prospective, observational, multi-centre study to evaluate the efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM with inadequate glycemic control

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Teneligliptin 20mg

• Study Type: Observational
• Enrollment (Actual): 2983

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Suwon, Gyeonggi, Korea, Republic of
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Type 2 DM patients

Description

Inclusion Criteria:

1. The subject is aged ≥19 years
2. The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit.
3. Patient who was treated with same dosage of DPP4 inhibitor for at least 12 weeks prior to baseline visit (if patient who has been treated with DPP4 inhibitor and any other antidiabetic drugs, antidiabetic drugs should also have been kept same dosage for at least 12 weeks prior to baseline.)
4. Patient with HbA1c≥7.0% at baseline visit
5. Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for glycemic control based on the investigator's judgment
6. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and understand this information, voluntarily signed and dated the written informed consent in compliance with protocol before inclusion in the study

Exclusion Criteria:

1. Patient with hypersensitivity to the Teneligliptin
2. Patient who treat the Teneligliptin prior to baseline visit
3. A pregnant or lactating female patient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	To assess change from baseline in glycated hemoglobin (HbA1c)	at 12 weeks after switching to Teneligliptin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	To assess change from baseline in HbA1c	at 24, 52 weeks after switching to Teneligliptin
Change in FBG	To assess change from baseline in fasting blood glucose (FBG)	at 12, 24, 52 weeks after switching to Teneligliptin
Change in body weight, BMI	To assess change from baseline in body weight and body mass index (BMI)	at 12, 24, 52 weeks after switching to Teneligliptin
Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)	To assess change from baseline in serum lipid profile (total cholesterol, LDL and HDL cholesterol, triglyceride)	at 12, 24, 52 weeks after switching to Teneligliptin
The percentage of patients with HbA1c <7.0% and <6.5%	To assess the percentage of patients with HbA1c <7.0% and <6.5%	at Weeks 12, 24, and 52 of teneligliptin treatment
The percentage of patients with a decrease from baseline in HbA1c	To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5%	at Weeks 12, 24, and 52 of teneligliptin treatment
Safety Outcome	To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)	at Weeks 12, 24, and 52 of teneligliptin treatment

Collaborators and Investigators

• Sponsor: Handok Inc.
• Investigators: Principal Investigator: Kwan Woo Lee, MD, Ph.D, Ajou University School of Medicine

Publications and helpful links

General Publications

• Kim HJ, Kim YS, Lee CB, Choi MG, Chang HJ, Kim SK, Yu JM, Kim TH, Lee JH, Ahn KJ, Kim K, Lee KW. 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. Diabetes Ther. 2019 Aug;10(4):1271-1282. doi: 10.1007/s13300-019-0628-0. Epub 2019 May 11.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2016
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HD_TEN_OS2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No