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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DA-5218
DrugDA-5218 + DA-5218-C placebo
DA-5218-C
DrugDA-5218-C + DA-5218 placebo
Treatment groups
238 Participants
are divided into 2 treatment groupsGroup A: DA-5218Experimental treatment 1 intervention
Group B: DA-5218-CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline of HbA1c(%)
Time frame
24 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: