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.
Status | Active, not recruiting |
Enrollment | 136 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent), Endothelial dysfunction: FMD below 6.7%, LDL cholesterol level less than 140 mg/dl, Patients agreed to Informed Consent Form Exclusion Criteria: (Key exclusion criteria) Uncontrolled arterial hypertension (above 139/90 mmHg) or hypotension (below 80/50 mmHg), Severe diabetic complication: diabetic nephropathy, diabetic neuropathy, diabetic retinopathy, diabetic vascular complications |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Internal medicine, Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Han Wha Pharma Co., Ltd. |
Korea, Republic of,
Lee JO, Auger C, Park DH, Kang M, Oak MH, Kim KR, Schini-Kerth VB. An ethanolic extract of Lindera obtusiloba stems, YJP-14, improves endothelial dysfunction, metabolic parameters and physical performance in diabetic db/db mice. PLoS One. 2013 Jun 3;8(6):e65227. doi: 10.1371/journal.pone.0065227. Print 2013. — View Citation
Lee JO, Oak MH, Jung SH, Park DH, Auger C, Kim KR, Lee SW, Schini-Kerth VB. An ethanolic extract of Lindera obtusiloba stems causes NO-mediated endothelium-dependent relaxations in rat aortic rings and prevents angiotensin II-induced hypertension and endothelial dysfunction in rats. Naunyn Schmiedebergs Arch Pharmacol. 2011 Jun;383(6):635-45. doi: 10.1007/s00210-011-0643-9. Epub 2011 May 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | HbA1c Serum lipids (LDL, HDL and TG) | 12 weeks | No | |
Other | Serum Lipids (LDL, HDL and TG) | 12 weeks | No | |
Primary | Flow-mediated dilation (FMD) | 12 weeks | No | |
Secondary | Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure | 8 weeks | No | |
Secondary | Homeostasis model assessment-insulin resistance (HOMA-IR) | 4, 8, 12 weeks | No | |
Secondary | Systolic and Diastolic Blood Pressure | 4, 8, 12 weeks | No |
Status | Clinical Trial | Phase | |
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