A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise. This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Korea University Anam Hospital
Seoul, South Korea
RECRUITINGchange in HbA1c at weeks 12 from baseline
change in HbA1c at weeks 12 from baseline
Time frame: at weeks 12 from baseline
change in HbA1c at weeks 6 from baseline
change in HbA1c at weeks 6 from baseline
Time frame: at weeks 6 from baseline
percentage of subjects with HbA1c level below 7.0% at weeks 12
percentage of subjects with HbA1c level below 7.0% at weeks 12
Time frame: at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12
Time frame: at weeks 12
change in Glycoalbumin at weeks 6 and 12 from baseline
change in Glycoalbumin at weeks 6 and 12 from baseline
Time frame: at weeks 6 and 12 from baseline
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PO, QD