Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes
ConditionDiabete Mellitus
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorDong-A ST Co., Ltd.
About this trial
This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-5218 in patients with type 2 diabetes who have inadequate glycemic control with metformin
Eligibility criteria
Qualifiers
7.0%≤HbA1c≤10.5% and fasting glucose≤270mg/dL
Treated with 1,000mg/day dose of metformin for at least 8 weeks
Disqualifiers
Type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
eGFR<45mL/min/1.73m2
ALT and AST 3 times or higher than upper normal range
Determined by investigator as unfit to participate in a clinical trial due to other reasons
Trial design
Treatments tested in this trial
- DA-5218
- DA-5218-C
Treatment groups
238 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov