Diabetic Complication Clinical Trial
Official title:
Multicenter, Randomized, Double Blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Safety and Efficacy of YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
The purpose of this study is to evaluate the safety and efficacy of YJP-14 capsules for the treatment of endothelial dysfunction in patients with diabetes mellitus.
The primary purpose of this study is to demonstrate superior effect of YJP-14 three doses,
25, 50 and 100 mg t.i.d on endothelial dysfunction in diabetes mellitus indicated as mean
change difference of flow-mediated dilation (FMD), compared to placebo group after treatment
of 12 weeks.
The secondary purposes of this study are divided into three as follows;
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on
endothelial dysfunction in diabetes mellitus indicated as mean change difference of
FMD, compared to placebo group after treatment of 8 weeks.
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on insulin
resistance in diabetes mellitus indicated as mean change difference of Homeostasis
Model Assessment-Insulin Resistance (HOMA-IR), compared to placebo group after
treatment of 4, 8 and 12 weeks.
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on mean
change difference of blood pressure in diabetes mellitus, compared to placebo group
after treatment of 4, 8 and 12 weeks.
The exploratory purposes of this study are divided into two as follows;
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on blood
glucose level in diabetes mellitus indicated as mean change difference of HbA1c,
compared to placebo group after treatment of 12 weeks.
- Clinically significant effect of YJP-14 three doses, 25, 50 and 100 mg t.i.d on
vascular stiffness in diabetes mellitus indicated as mean change difference of blood
lipids (LDL, HDL and TG), compared to placebo group after treatment of 12 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05087225 -
Suspicion of Hypoglycemic Effect of mRNA Based Covid-19 Vaccines (Polyethylene Glycol) Will Happen , Observational Study on Diabetic Patients at Saudia Arabia
|
||
Active, not recruiting |
NCT05809817 -
Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data
|
||
Recruiting |
NCT03908762 -
mHealth Titration and Management
|
N/A | |
Completed |
NCT02364323 -
Genetic Testing and Counseling to Reduce Diabetic Complications
|
N/A | |
Completed |
NCT04706377 -
Vitamin B12 Supplementation in Diabetic Neuropathy
|
N/A | |
Not yet recruiting |
NCT03767478 -
Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy
|
N/A |