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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

ConditionDiabete Mellitus
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • DA-2811

    Drug

    DA-2811 + DA-2811-R2, orally, once daily

  • DA-2811-C

    Drug

    DA-2811-C + DA-2811-R1, orally, once daily

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: DA-2811Experimental treatment 1 intervention
Group B: DA-2811-CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Time frame
Change from baseline at 12 weeks

Secondary outcomes

1

HbA1c

Time frame
Change from baseline at 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dong-A ST Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: