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Not yet recruiting NCT07239440

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

Phase II Interventional Diabete Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DA-2811, DA-2811-C.
Who it may be relevant to
Registry conditions: Diabete Mellitus. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug DA-2811
    DA-2811 + DA-2811-R2, orally, once daily
  • Drug DA-2811-C
    DA-2811-C + DA-2811-R1, orally, once daily

Primary outcome measures

  • HbA1c [Time frame: Change from baseline at 12 weeks]
Secondary outcome measures (1)
  • HbA1c [Time frame: Change from baseline at 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT07239440 · DA2811_DMLD_II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗