Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Teneligliptin 20mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Teneligliptin 20mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | To assess change from baseline in glycated hemoglobin (HbA1c) | at 12 weeks after switching to Teneligliptin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | To assess change from baseline in HbA1c | at 24, 52 weeks after switching to Teneligliptin | 
| Change in FBG | To assess change from baseline in fasting blood glucose (FBG) | at 12, 24, 52 weeks after switching to Teneligliptin | 
| Change in body weight, BMI | To assess change from baseline in body weight and body mass index (BMI) | at 12, 24, 52 weeks after switching to Teneligliptin | 
| 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) | at 12, 24, 52 weeks after switching to Teneligliptin | 
| The percentage of patients with HbA1c <7.0% and <6.5% | To assess 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 | To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5% | at Weeks 12, 24, and 52 of teneligliptin treatment | 
| Safety Outcome | To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.) | at Weeks 12, 24, and 52 of teneligliptin treatment |