Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

Celltrion Healthcare

Status and phase: Enrolling; Phase 3

Conditions: DM; T2DM; Diabete Type 2

Treatments: Drug: Metformin; Drug: Alogliptin; Drug: empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07093476

CT-L02-301

Details and patient eligibility

About

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.

Enrollment: 171 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

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171 participants in 3 patient groups, including a placebo group

Study group 1

Active Comparator group

Description:

Metformin + Alogliptin + Empagliflozin Xmg

Treatment:

Drug: empagliflozin

Drug: Alogliptin

Drug: Metformin

Study group 2

Active Comparator group

Description:

Metformin + Alogliptin + Empagliflozin Ymg

Treatment:

Drug: empagliflozin

Drug: Alogliptin

Drug: Metformin

Control Group

Placebo Comparator group

Description:

Metformin + Alogliptin

Treatment:

Drug: Alogliptin

Drug: Metformin