Diabetic ComplicationPhase 2NCT01836172
YJP-14 Capsules for the Treatment of Endothelial Dysfunction in Patients With Diabetes Mellitus
A Phase 2 study testing YJP-14 in people with Diabetic Complication, run by Han Wha Pharma Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Complication
- What is being tested?
- YJP-14
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Internal medicine, Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
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.
Read the 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.
- Conditions
- Diabetic Complication
- Being tested
- YJP-14
- Keywords
- The treatment of diabetic complication
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YJP-14Drug
Also called An 50% ethanolic extract of Lindera obtusiloba stems
An 50% ethanolic extract of Lindera obtusiloba stems
| Study group | Role | What they receive |
|---|---|---|
| Placebo t.i.d. | Placebo comparator | Placebo t.i.d. Receives: Drug: YJP-14 |
| YJP-14 25 mg t.i.d. | Placebo comparator | YJP-14 25 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. Receives: Drug: YJP-14 |
| YJP-14 50 mg t.i.d. | Placebo comparator | YJP-14 50 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. Receives: Drug: YJP-14 |
| YJP-14 100 mg t.i.d. | Placebo comparator | YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. YJP-14 100 mg t.i.d. Receives: Drug: YJP-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation (FMD)
Measured: 12 weeks
Secondary outcomes (3)
Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure
Measured: 8 weeks
Homeostasis model assessment-insulin resistance (HOMA-IR)
Measured: 4, 8, 12 weeks
Systolic and Diastolic Blood Pressure
Measured: 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Wha Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung-Hee Oh, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836172
- Sponsor's protocol ID
- HW2012-YJP002
- Status last verified
- Aug 2016
- First submitted
- 17 Apr 2013
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21533989Lee 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.
PubMed 23755196
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01836172
- Acronym / sponsor ID
- HW2012-YJP002
- Conditions
- Diabetic Complication
- Keywords
- The treatment of diabetic complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Han Wha Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo t.i.d. | Placebo comparator | Drug: YJP-14Placebo t.i.d. |
| YJP-14 25 mg t.i.d. | Placebo comparator | Drug: YJP-14YJP-14 25 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. |
| YJP-14 50 mg t.i.d. | Placebo comparator | Drug: YJP-14YJP-14 50 mg t.i.d. YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. |
| YJP-14 100 mg t.i.d. | Placebo comparator | Drug: YJP-14YJP-14 is a 50% ethanolic extract of Lindera obtusiloba stems. YJP-14 100 mg t.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YJP-14Also: An 50% ethanolic extract of Lindera obtusiloba stemsAn 50% ethanolic extract of Lindera obtusiloba stems | Drug | Placebo t.i.d., YJP-14 100 mg t.i.d., YJP-14 25 mg t.i.d., YJP-14 50 mg t.i.d. |
Primary outcome
Flow-mediated dilation (FMD)
Time frame: 12 weeks
3 secondary outcomes
Flow-mediated dilation (FMD) Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) Systolic and Diastolic Blood Pressure
Time frame: 8 weeks
Homeostasis model assessment-insulin resistance (HOMA-IR)
Time frame: 4, 8, 12 weeks
Systolic and Diastolic Blood Pressure
Time frame: 4, 8, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Background: PubMed 21533989Lee 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.
- Background: PubMed 23755196Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung-Hee Oh, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YJP-14 in people with Diabetic Complication, run by Han Wha Pharma Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation (FMD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836172, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.