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CompletedNCT05743907Updated Mar 14, 2025

Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control

A Phase 4 interventional study of DA-2811 and Forxiga in Diabetes Mellitus, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Dong-A ST Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
231
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 231 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with 7.0%≤HbA1c≤10.0% at screening
  • Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
  • Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
  • Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion criteria

Exclusion Criteria:

  • Subjects with fasting plasma glucose≥240mg/dL at screening
  • Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
  • Subject with ALT and AST 3 times or higher than upper normal range
  • Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
231 participants (actual)

Study arms

  • Experimental
    DA-2811

    DA-2811 + Forxiga placebo

    Drug: DA-2811

  • Active comparator
    Forxiga

    Forxiga + DA-2811 placebo

    Drug: Forxiga

Interventions

  • DrugDA-2811

    DA-2811 Group: DA-2811 + Forxiga placebo

  • DrugForxiga

    Forxiga Group: Forxiga + DA-2811 placebo

06

What researchers measure

Primary outcomes

  1. HbA1c(%)

    Time frame: Change from baseline at 24 weeks

07

Study locations

1 site
  • The Catholic University of Korea Bucheon St. Mary's Hospital
    Bucheon, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05743907
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Feb 24, 2023
Start date
Apr 25, 2023
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025
Last update
Mar 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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