Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

NCT03793023 | Completed

• 1 other identifier: HD_TEN_OS2015
• Study Type: observational
• Target: 2,983
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  To assess change from baseline in glycated hemoglobin (HbA1c)

  at 12 weeks after switching to Teneligliptin

Secondary Outcomes (7)

• Change in HbA1c

  at 24, 52 weeks after switching to Teneligliptin

• Change in FBG

  at 12, 24, 52 weeks after switching to Teneligliptin

• Change in body weight, BMI

  at 12, 24, 52 weeks after switching to Teneligliptin

• Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)

  at 12, 24, 52 weeks after switching to Teneligliptin

• The percentage of patients with HbA1c <7.0% and <6.5%

  at Weeks 12, 24, and 52 of teneligliptin treatment

Interventions

Teneligliptin 20mg DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 DM patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31079357 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kwan Woo Lee, MD, Ph.D

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: January 5, 2016
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)