Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
Not Applicable
Recruiting
- Conditions
- T2DMDiabete Type 2DM
- Interventions
- Registration Number
- NCT07093476
- Lead Sponsor
- Celltrion
- Brief Summary
Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 171
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 Study group 1 Metformin Metformin + Alogliptin + Empagliflozin Xmg Study group 2 empagliflozin Metformin + Alogliptin + Empagliflozin Ymg Study group 1 Alogliptin Metformin + Alogliptin + Empagliflozin Xmg Study group 1 empagliflozin Metformin + Alogliptin + Empagliflozin Xmg Study group 2 Metformin Metformin + Alogliptin + Empagliflozin Ymg Study group 2 Alogliptin Metformin + Alogliptin + Empagliflozin Ymg Control Group Metformin Metformin + Alogliptin Control Group Alogliptin Metformin + Alogliptin
- Primary Outcome Measures
Name Time Method HbA1c Week 24 of the Treatment Change from Baseline in HbA1c
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celltrion
🇰🇷Seoul, Korea, Republic of
Celltrion🇰🇷Seoul, Korea, Republic of