About this trial
This study is a multicenter, double-blind, active-controlled, randomized, parallel clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing BT-1 and BT-2 combination therapy in patients with type 2 diabetes who have inadequate glycemic control
Eligibility criteria
Qualifiers
Patients with type II diabetes mellitus aged 19 years or older
Patients with fasting plasma glucose≤270mg/dL at the screening visit
Patients with 18.5kg/m²≤BMI≤40kg/m² at the screening visit
Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
Disqualifiers
Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
Patients with severe infectious disease or severe traumatic systemic disorders
Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
Trial design
Treatments tested in this trial
- DA-2811
- DA-2811-C