Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin (CT-L03)

Celltrion Healthcare

Status and phase: Active, not recruiting; Phase 3

Conditions: T2DM

Treatments: Drug: Empagliflozin; Drug: CT-L03 Group 1; Drug: CT-L03 Group 2; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571591

CT-L03-301

CT-L03 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 582 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

582 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Treatment:

Drug: Metformin

Drug: CT-L03 Group 1

Drug: Empagliflozin

Group 2

Active Comparator group

Treatment:

Drug: Metformin

Drug: CT-L03 Group 2

Drug: Empagliflozin

Placebo

Placebo Comparator group

Treatment:

Drug: Metformin

Drug: Placebo

Drug: Empagliflozin