This is a Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications.
After a screening, 114 patients will be stratified randomized in a 1:1:1 ratio to the 3 arms (PH100 800mg/day, PH100 1600mg/day, Placebo) to evaluate the safety and efficacy of PH100. Subjects will visit the centers on Week 4, 8 and 12 during the entire 12-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
82
Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.
hs-CRP (high-sensitivity C-reactive protein)
Change in hs-CRP level compared to baseline after 12 weeks of investigational product administration
Time frame: Visit 2(Baseline Visit) vs Visit 5(week 12)
hs-CRP
Change in hs-CRP level compared to baseline after 4 weeks, 8 weeks of investigational product administration
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8)
hs-CRP: monthly rate of change
Change in hs-CRP level monthly
Time frame: Between Visit 2(Baseline Visit) and Visit 3(week 4), Between Visit 3(week 4) and Visit 4(week 8), Between Visit 4(week 8) and Visit 5(week 12)
Interleukin-6 (IL-6)
Change in IL-6 \[Inflammatory Marker\]
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Tumor Necrosis Factor-α (TNF- α)
Change in TNF- α \[Inflammatory Marker\]
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Malondialdehyde (MDA)
Change in MDA \[Biomarkers of oxidative stress\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Oxidized Low Density Lipoprotein (Oxidized LDL)
Change in Oxidized LDL \[Biomarkers of oxidative stress\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Glutathione Peroxidase (GPX)
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Change in GPX \[Biomarkers of oxidative stress\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Superoxide Dismutase (SOD)
Change in SOD \[Biomarkers of oxidative stress\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Total AntiOxidants (TAS)
Change in TAS \[Biomarkers of oxidative stress\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
HbA1c
Change in HbA1c level compared to Visit1(screening) after 12 weeks of investigational product administration
Time frame: Visit1(screening), Visit 5(week 12)
Adiponectin
Change in Adiponectin level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Free Fatty Acid
Change in Free Fatty Acid level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
High Density Lipoprotein-cholesterol (HDL-C)
Change in HDL-C level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration \[Lipid Profile\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Low Density Lipoprotein-cholesterol (LDL-C)
Change in LDL-C level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration \[Lipid Profile\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Triglyceride (TG)
Change in TG level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration \[Lipid Profile\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Total Cholesterol (TC)
Change in TC level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration \[Lipid Profile\]
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Homocysteine
Change in Homocysteine level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Fibrinogen
Change in Fibrinogen level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
MACE (Major Adverse Cardiovascular Events)
Incidence rate of MACE (Major Adverse Cardiovascular Events) during investigational product administration
Time frame: Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Left Ventricular Ejection Fraction
Change in LVEFF compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration by Echocardiogram
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Blood Pressure (Systolic Blood Pressure, Diastolic Blood Pressure)
Change in SiSBP, SiDBP
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
BMI
Change in BMI
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Waist-hip ratio
Change in Waist-hip ratio
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
AE (Adverse Events)
\[Safety and Tolerability\] Incidence of AEs during investigational product administration
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Pulse
\[Safety and Tolerability\] Check the Vital Sign (pulse) every visit schedule
Time frame: Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Body Temperature
\[Safety and Tolerability\] Check the Vital Sign (body temperature) every visit schedule
Time frame: Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)