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

Dong-A ST Co., Ltd.1 site in 1 country231 target enrollmentApril 25, 2023

ConditionsDiabetes Mellitus

InterventionsDA-2811 Forxiga

DrugsDA-2811 Forxiga

Overview

Phase: Phase 4
Intervention: DA-2811
Conditions: Diabetes Mellitus
Sponsor: Dong-A ST Co., Ltd.
Enrollment: 231
Locations: 1
Primary Endpoint: HbA1c(%)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 25, 2023

End Date

March 10, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dong-A ST Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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