| Trial ID: | L1870 |
| Source ID: | NCT06571591
|
| Associated Drug: |
Ct-L03 Group 1
|
| Title: |
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin with Metformin
|
| Acronym: |
CT-L03
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
T2DM
|
| Interventions: |
DRUG: CT-L03 Group 1|DRUG: CT-L03 Group 2|DRUG: Placebo|DRUG: Empagliflozin|DRUG: Metformin
|
| Outcome Measures: |
Primary: HbA1c, Change from Baseline in HbA1c, Week 24 of the Treatment | Secondary: HbA1c, Change from Baseline in HbA1c, Week 12 of the Treatment|FPG, Change from Baseline in fasting plasma glucose, Week 12 and 24 of the Treatment|Body weight, Change from Baseline in body weight, Week 12 and 24 of the Treatment
|
| Sponsor/Collaborators: |
Sponsor: Celltrion
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
582
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-08-27
|
| Completion Date: |
2026-05
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-20
|
| Locations: |
Celltrion, Incheon, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06571591
|
