YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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;
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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.
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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;
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo t.i.d. Placebo t.i.d. |
Drug: YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Other Names:
|
| Placebo Comparator: YJP-14 25 mg t.i.d. YJP-14 25 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. |
Drug: YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Other Names:
|
| Placebo Comparator: YJP-14 50 mg t.i.d. YJP-14 50 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. |
Drug: YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Other Names:
|
| Placebo Comparator: YJP-14 100 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. YJP-14 100 mg t.i.d. |
Drug: YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Flow-mediated dilation (FMD) [12 weeks]
Secondary Outcome Measures
- Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure [8 weeks]
- Homeostasis model assessment-insulin resistance (HOMA-IR) [4, 8, 12 weeks]
- Systolic and Diastolic Blood Pressure [4, 8, 12 weeks]
Other Outcome Measures
- HbA1c Serum lipids (LDL, HDL and TG) [12 weeks]
- Serum Lipids (LDL, HDL and TG) [12 weeks]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Internal medicine, Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Han Wha Pharma Co., Ltd.
Investigators
- Principal Investigator: Byung-Hee Oh, M.D., Ph.D., Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- HW2012-YJP002