Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
Phase 3
Recruiting
- Conditions
- T2DM
- Interventions
- Registration Number
- NCT06571591
- Lead Sponsor
- Celltrion
- Brief Summary
Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 582
Inclusion Criteria
- Adults at the time of signing the Informed Consent Form (ICF)
- Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
- Diagnosed with T2DM
Exclusion Criteria
- Diagnosed with other types of diabetes than T2DM
- History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy
- Uncontrolled severe complications of diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 CT-L03 Group 1 - Group 1 Empagliflozin - Group 1 Metformin - Group 2 CT-L03 Group 2 - Group 2 Empagliflozin - Group 2 Metformin - Placebo Placebo - Placebo Empagliflozin - Placebo Metformin -
- Primary Outcome Measures
Name Time Method HbA1c Week 24 of the Treatment Change from Baseline in HbA1c
- Secondary Outcome Measures
Name Time Method HbA1c Week 12 of the Treatment Change from Baseline in HbA1c
Body weight Week 12 and 24 of the Treatment Change from Baseline in body weight
FPG Week 12 and 24 of the Treatment Change from Baseline in fasting plasma glucose
Trial Locations
- Locations (1)
Celltrion
🇰🇷Incheon, Korea, Republic of