NCT07229534

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for phase_4

Timeline
18mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Nov 2025Nov 2027

Study Start

First participant enrolled

November 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Diabete Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of HbA1c(%)

    24 weeks

Study Arms (2)

DA-5218

EXPERIMENTAL
Drug: DA-5218

DA-5218-C

ACTIVE COMPARATOR
Drug: DA-5218-C

Interventions

DA-5218DRUG

DA-5218 + DA-5218-C placebo

DA-5218
DA-5218-CDRUG

DA-5218-C + DA-5218 placebo

DA-5218-C

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11