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

Dong-A ST

Status and phase

Not yet enrolling

Phase 2

Conditions

Diabete Mellitus

Treatments

Drug: DA-2811-C

Drug: DA-2811

Study type

Interventional

Funder types

Industry

Identifiers

NCT07239440

DA2811_DMLD_II

Details and patient eligibility

About

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

Enrollment

288 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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/m^2≤BMI≤40kg/m^2 at the screening visit
Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion criteria

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
Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption