Diabetes Mellitus
Conditions
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
Interventions
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c(%) | Change from baseline at 24 weeks |
Countries
South Korea
Outcome results
None listed