Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

NCT ID: NCT03793023

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2983 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-05

Study Completion Date

2019-09-23

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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Teneligliptin 20mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kwan Woo Lee, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31079357 (View on PubMed)

Other Identifiers

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HD_TEN_OS2015

Identifier Type: -

Identifier Source: org_study_id

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