Type 2 Diabetes Mellitus
Conditions
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
Interventions
Sponsors
Handok Inc.
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | at 12 weeks after switching to Teneligliptin | To assess change from baseline in glycated hemoglobin (HbA1c) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Change in HbA1c | at 24, 52 weeks after switching to Teneligliptin | To assess change from baseline in HbA1c |
| 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.) |
| 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% |
Countries
South Korea
Outcome results
None listed