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

A Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07229534
Enrollment
238
Registered
2025-11-17
Start date
2025-11-30
Completion date
2027-11-30
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Mellitus

Brief summary

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

Interventions

DRUGDA-5218

DA-5218 + DA-5218-C placebo

DRUGDA-5218-C

DA-5218-C + DA-5218 placebo

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

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

* 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

Design outcomes

Primary

MeasureTime frame
Change from baseline of HbA1c(%)24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026