| Trial ID: | L3053 |
| Source ID: | NCT05504226
|
| Associated Drug: |
Teneligliptin (As Teneligliptin Hydrobromide) 20 Mg Oral Tablet
|
| Title: |
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
|
| Acronym: |
TERA 305
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet|DRUG: Teneligliptin Placebo Oral Tablet
|
| Outcome Measures: |
Primary: Changes from baseline HbA1c at week 24, Baseline (week 0) and week 24 | Secondary: Changes from baseline FPG at week 24, Baseline (week 0) and week 24|Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24, Baseline (week 0) and week 24|Changes from baseline in BMI at week 24, Baseline (week 0) and week 24
|
| Sponsor/Collaborators: |
Sponsor: Handok Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
214
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-12
|
| Completion Date: |
2024-06-18
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-27
|
| Locations: |
Seoul National University Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT05504226
|
