Clinical Trial to Evaluate the Efficacy and Safety of DA-... | NCT07229534

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

NCT07229534

Sponsor

Dong-A ST Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Nov 17, 2025Actual

Enrollment

238Estimated

Phase

Phase 4

Conditions

Diabete Mellitus

Interventions

DA-5218
DA-5218-C

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2025Estimated

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Nov 13, 2025

First Posted Date

Nov 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

238Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-5218	Experimental		Drug: DA-5218
DA-5218-C	Active Comparator		Drug: DA-5218-C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5218	Drug	DA-5218 + DA-5218-C placebo	DA-5218
DA-5218-C

Measure	Description	Time Frame
Change from baseline of HbA1c(%)		24 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided