Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

Handok

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Teneligliptin 20mg

Study type: Observational

Funder types: Industry

Identifiers

NCT03793023

HD_TEN_OS2015

Details and patient eligibility

About

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

Enrollment: 2,983 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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