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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorDong-A ST Co., Ltd.

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

Treatment groups

288 Participants
are divided into 2 treatment groups

Sponsors and collaborators