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

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus

Treatments

Drug: Forxiga

Drug: DA-2811

Study type

Interventional

Funder types

Industry

Identifiers

NCT05743907

DA2811_DM_IV

Details and patient eligibility

About

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

Enrollment

231 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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