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NCT05743907 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05743907
Other study ID # DA2811_DM_IV
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 24, 2023
Est. completion date December 2024

Study information
Verified date February 2024
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 232
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DA-2811
DA-2811 Group: DA-2811 + Forxiga placebo
• Forxiga
Forxiga Group: Forxiga + DA-2811 placebo

Locations
Country Name City State
Korea, Republic of The Catholic University of Korea Bucheon St. Mary's Hospital Bucheon

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c(%) Change from baseline at 24 weeks
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