Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT03793023
• Lead Sponsor: Handok Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-05
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2983

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	at 12 weeks after switching to Teneligliptin	To assess change from baseline in glycated hemoglobin (HbA1c)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggi, Korea, Republic of