Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
- Registration Number
- NCT05743907
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
Inclusion Criteria
- Subjects with 7.0%≤HbA1c≤10.0% at screening
- Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Exclusion Criteria
- Subjects with fasting plasma glucose≥240mg/dL at screening
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- Subject with ALT and AST 3 times or higher than upper normal range
- Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Forxiga Forxiga Forxiga + DA-2811 placebo DA-2811 DA-2811 DA-2811 + Forxiga placebo
- Primary Outcome Measures
Name Time Method HbA1c(%) Change from baseline at 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Catholic University of Korea Bucheon St. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of