T2DM
Conditions
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.
Interventions
DRUGCT-L03 Group 1
tablets, QD, oral administration
DRUGCT-L03 Group 2
tablets, QD, oral administration
DRUGPlacebo
tablets, QD, oral administration
DRUGEmpagliflozin
tablet, QD, oral administration
DRUGMetformin
tablets, oral administration
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Week 24 of the Treatment | Change from Baseline in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Week 12 of the Treatment | Change from Baseline in HbA1c |
| FPG | Week 12 and 24 of the Treatment | Change from Baseline in fasting plasma glucose |
| Body weight | Week 12 and 24 of the Treatment | Change from Baseline in body weight |
Countries
South Korea
Outcome results
None listed