NCT05743907

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-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

February 15, 2023

Last Update Submit

March 12, 2025

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c(%)

    Change from baseline at 24 weeks

Study Arms (2)

DA-2811

EXPERIMENTAL

DA-2811 + Forxiga placebo

Drug: DA-2811

Forxiga

ACTIVE COMPARATOR

Forxiga + DA-2811 placebo

Drug: Forxiga

Interventions

DA-2811DRUG

DA-2811 Group: DA-2811 + Forxiga placebo

DA-2811
ForxigaDRUG

Forxiga Group: Forxiga + DA-2811 placebo

Forxiga

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

April 25, 2023

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Locations

KR(1)