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
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DA-2811
Forxiga
DA-2811 + Forxiga placebo
Forxiga + DA-2811 placebo