A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes
| Registry | NCT03508323 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 65 (Actual) |
| Sponsor | Handok Inc. (Industry) |
| Conditions | Type 2 Diabetes Mellitus |
| Interventions | Teneligliptin, Placebo (Drug) |
| Dates | start 2018-04-03, primary completion 2019-12-12, completion 2019-12-12, first posted 2018-04-25, last updated 2022-06-30 |
| Locations | 1 site in South Korea |
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All trials for Type 2 Diabetes Mellitus All trials of Teneligliptin All trials of Placebo
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Teneligliptin | Experimental | Drug: Teneligliptin | |
| Placebo | Placebo comparator | Drug: Placebo |
Sex: All, ages: 65 Years to any
Inclusion Criteria: * Patients who are 65 years or older on screening * Patients with type 2 diabetes mellitus * Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit * Patients with FPG < 270mg/dL on screening visit Exclusion Criteria: \-
| Facility | City | Country | Status |
|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |