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

Handok Inc.1 site in 1 country2,983 target enrollmentJanuary 5, 2016

ConditionsType 2 Diabetes Mellitus

DrugsTeneligliptin 20mg

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Handok Inc.
Enrollment: 2983
Locations: 1
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 5, 2016

End Date

September 23, 2019

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Handok Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: at 12 weeks after switching to Teneligliptin

To assess change from baseline in glycated hemoglobin (HbA1c)

Secondary Outcomes

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)
The percentage of patients with a decrease from baseline in HbA1c(at Weeks 12, 24, and 52 of teneligliptin treatment)
Safety Outcome(at Weeks 12, 24, and 52 of teneligliptin treatment)