Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes

Dong-A ST

Status and phase: Not yet enrolling; Phase 4

Conditions: Diabete Mellitus

Treatments: Drug: DA-5218-C; Drug: DA-5218

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229534

DA5218_DMSD_IV

Details and patient eligibility

About

This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-5218 in patients with type 2 diabetes who have inadequate glycemic control with metformin

Enrollment: 238 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 7.0%≤HbA1c≤10.5% and fasting glucose≤270mg/dL
• Treated with 1,000mg/day dose of metformin for at least 8 weeks

Exclusion criteria

• Type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
• eGFR<45mL/min/1.73m2
• ALT and AST 3 times or higher than upper normal range
• Determined by investigator as unfit to participate in a clinical trial due to other reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 2 patient groups

DA-5218

Experimental group

Treatment:

Drug: DA-5218

DA-5218-C

Active Comparator group

Treatment:

Drug: DA-5218-C