AzTrials
AzTrials

Type 2 Diabetes MellitusNCT03793023

Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

An observational study of Type 2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Teneligliptin 20mg
How many people
2,983 participants
Where
1 siteSouth Korea
Study dates
5 Jan 2016to 23 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

Study population: Type 2 DM patients

Who may be able to join

  • The subject is aged ≥19 years
  • The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit.
  • 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.)
  • Patient with HbA1c≥7.0% at baseline visit
  • Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for glycemic control based on the investigator's judgment
  • 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

Who cannot join

  • Patient with hypersensitivity to the Teneligliptin
  • Patient who treat the Teneligliptin prior to baseline visit
  • A pregnant or lactating female patient

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Ajou University Hospital

    Suwon, Gyeonggi-do

Other trials in South Korea

About this study

Official title: 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

Being tested
Teneligliptin 20mg
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teneligliptin 20mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    To assess change from baseline in glycated hemoglobin (HbA1c)

    Measured: at 12 weeks after switching to Teneligliptin

Secondary outcomes (7)

  1. Change in HbA1c

    To assess change from baseline in HbA1c

    Measured: at 24, 52 weeks after switching to Teneligliptin

  2. Change in FBG

    To assess change from baseline in fasting blood glucose (FBG)

    Measured: at 12, 24, 52 weeks after switching to Teneligliptin

  3. Change in body weight, BMI

    To assess change from baseline in body weight and body mass index (BMI)

    Measured: at 12, 24, 52 weeks after switching to Teneligliptin

  4. 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)

    Measured: at 12, 24, 52 weeks after switching to Teneligliptin

  5. The percentage of patients with HbA1c <7.0% and <6.5%

    To assess the percentage of patients with HbA1c <7.0% and <6.5%

    Measured: at Weeks 12, 24, and 52 of teneligliptin treatment

  6. 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%

    Measured: at Weeks 12, 24, and 52 of teneligliptin treatment

  7. Safety Outcome

    To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)

    Measured: at Weeks 12, 24, and 52 of teneligliptin treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start5 Jan 2016
  3. Primary completion23 Sep 2019
  4. Study completion23 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
2,983 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03793023
Sponsor's protocol ID
HD_TEN_OS2015
Status last verified
Jan 2025
First submitted
2 Jan 2019
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31079357

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: at 12 weeks after switching to Teneligliptin). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03793023, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in