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Not yet recruiting NCT07229534

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

Phase IV Interventional Diabete Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DA-5218, DA-5218-C.
Who it may be relevant to
Registry conditions: Diabete Mellitus. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug DA-5218
    DA-5218 + DA-5218-C placebo
  • Drug DA-5218-C
    DA-5218-C + DA-5218 placebo

Primary outcome measures

  • Change from baseline of HbA1c(%) [Time frame: 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07229534 · DA5218_DMSD_IV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗