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Clinical Trial Details

Trial ID: L4356
Source ID: NCT04141241
Associated Drug: Ecklonia Cava Phlorotannin
Title: Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular
Acronym: PH100_IIa
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus With Circulatory Complciation
Interventions: DRUG: Ecklonia cava Phlorotannin
Outcome Measures: Primary: hs-CRP (high-sensitivity C-reactive protein), Change in hs-CRP level compared to baseline after 12 weeks of investigational product administration, Visit 2(Baseline Visit) vs Visit 5(week 12) | Secondary: hs-CRP, Change in hs-CRP level compared to baseline after 4 weeks, 8 weeks of investigational product administration, Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8)|hs-CRP: monthly rate of change, Change in hs-CRP level monthly, 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 \[Inflammatory Marker\], 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 \[Inflammatory Marker\], Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)|Malondialdehyde (MDA), Change in MDA \[Biomarkers of oxidative stress\], Visit 2(Baseline Visit), Visit 5(week 12)|Oxidized Low Density Lipoprotein (Oxidized LDL), Change in Oxidized LDL \[Biomarkers of oxidative stress\], Visit 2(Baseline Visit), Visit 5(week 12)|Glutathione Peroxidase (GPX), Change in GPX \[Biomarkers of oxidative stress\], Visit 2(Baseline Visit), Visit 5(week 12)|Superoxide Dismutase (SOD), Change in SOD \[Biomarkers of oxidative stress\], Visit 2(Baseline Visit), Visit 5(week 12)|Total AntiOxidants (TAS), Change in TAS \[Biomarkers of oxidative stress\], Visit 2(Baseline Visit), Visit 5(week 12)|HbA1c, Change in HbA1c level compared to Visit1(screening) after 12 weeks of investigational product administration, Visit1(screening), Visit 5(week 12)|Adiponectin, Change in Adiponectin level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration, 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, 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 \[Lipid Profile\], 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 \[Lipid Profile\], 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 \[Lipid Profile\], 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 \[Lipid Profile\], 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, 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, 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, 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, Visit 2(Baseline Visit), Visit 5(week 12)|Blood Pressure (Systolic Blood Pressure, Diastolic Blood Pressure), Change in SiSBP, SiDBP, Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)|BMI, Change in BMI, Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)|Waist-hip ratio, Change in Waist-hip ratio, 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, 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, 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, Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Sponsor/Collaborators: Sponsor: Bota Bio Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 82
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2016-03-04
Completion Date: 2018-05-04
Results First Posted:
Last Update Posted: 2019-11-06
Locations:
URL: https://clinicaltrials.gov/show/NCT04141241