YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Han Wha Pharma Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Han Wha Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01836172
First received: April 17, 2013
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Diabetic Complication
Drug: YJP-14
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Han Wha Pharma Co., Ltd.:

Primary Outcome Measures:
  • Flow-mediated dilation (FMD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Homeostasis model assessment-insulin resistance (HOMA-IR) [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Systolic and Diastolic Blood Pressure [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • HbA1c Serum lipids (LDL, HDL and TG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum Lipids (LDL, HDL and TG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: April 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo t.i.d.
Placebo t.i.d.
Drug: YJP-14
An 50% ethanolic extract of Lindera obtusiloba stems
Other Name: An 50% ethanolic extract of Lindera obtusiloba stems
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 Name: An 50% ethanolic extract of Lindera obtusiloba stems
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 Name: An 50% ethanolic extract of Lindera obtusiloba stems
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 Name: An 50% ethanolic extract of Lindera obtusiloba stems

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;

  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836172

Contacts
Contact: Young-mee YOON, Ph.D. +82-10-5564-8044 ymyoon@hwpharm.com
Contact: Hong-sik MOON, Ph.D. +82-10-6482-2130 hsmoon@hwpharm.com

Locations
Korea, Republic of
Internal medicine, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Byung-Hee Oh, M.D., Ph.D.    +82-2-2072-3345    ohbhmed@snu.ac.kr   
Principal Investigator: Byung-Hee Oh, M.D., Ph.D.         
Sponsors and Collaborators
Han Wha Pharma Co., Ltd.
Investigators
Principal Investigator: Byung-Hee Oh, M.D., Ph.D. Seoul National University Hospital
  More Information

Publications:
Responsible Party: Han Wha Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01836172     History of Changes
Other Study ID Numbers: HW2012-YJP002
Study First Received: April 17, 2013
Last Updated: March 23, 2015
Health Authority: Korea: Ministry of Food and Drug Safety
United States: Food and Drug Administration

Keywords provided by Han Wha Pharma Co., Ltd.:
The treatment of diabetic complication

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 07, 2015