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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin 20mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | To assess change from baseline in glycated hemoglobin (HbA1c) | at 12 weeks after switching to Teneligliptin |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 DM patients
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| Name | Affiliation | Role |
|---|---|---|
| Kwan Woo Lee, MD, Ph.D | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeonggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31079357 | Derived | Kim HJ, Kim YS, Lee CB, Choi MG, Chang HJ, Kim SK, Yu JM, Kim TH, Lee JH, Ahn KJ, Kim K, Lee KW. Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: A 12-Week Interim Report. Diabetes Ther. 2019 Aug;10(4):1271-1282. doi: 10.1007/s13300-019-0628-0. Epub 2019 May 11. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
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| 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 |
| D004700 | Endocrine System Diseases |