← Back to all trials
Not Yet Recruiting
NCT05743907
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
Conditions: Diabetes Mellitus
Sex: All
Ages: 19 Years – N/A
Phase: PHASE4
Enrollment: 232
Sponsor: Dong-A ST Co., Ltd.
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
Eligibility Criteria
Inclusion Criteria:Subjects with 7.0%≤HbA1c≤10.0%
at screeningSubjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screeningSubjects with 18.5kg/m2≤BMI≤40kg/m2 at screeningSubject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the studyExclusion Criteria:Subjects with fasting plasma glucose≥240mg/dL at screeningPatients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitusSubject with ALT and AST 3 times or higher than upper normal rangeSubject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
Source: ClinicalTrials.gov (NCT05743907). StuddyBuddy aggregates publicly available trial information.