- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01008163
A Dose-Finding, Efficacy and Safety Study of YY-351 in Patients With Type 2 Diabetes
February 21, 2019 updated by: Yuyu Pharma, Inc.
A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Efficacy and Safety of YY-351 in Patients With Type 2 Diabetes Mellitus
The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ginseng has been widely studied for treatment of diabetes, dyslipidemia and obesity.
Interestingly, in addition to ginseng root, ginseng berry and leaf were also shown to reduce blood glucose in diabetic models.
In our recent study, ginsam, vinegar extraction from Panax ginseng, which is enriched in the ginsenoside Rg3, has distinct beneficial effects on glucose metabolism and body weight control in an obese animal model of insulin resistance by changing the expression of genes involved in glucose and fatty acid metabolism.
Our group has also published that Rg3 improves insulin signaling and glucose uptake primarily by stimulating the expression of IRS-1 and GLUT4.
Thus, we have evaluated the efficacy, dose-response relationships and safety of a ginsam, a vinegar extract from Panax ginseng.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bungdang-Gu
-
Seongnam, Bungdang-Gu, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Previous diagnosis of Type 2 diabetes(more than 3months)
- Patients aged over 18 years
- FPG levels in the range : 126 - 270mg/dL or HbA1c : 7.0 - 12.0%
Exclusion Criteria:
- Pregnant women, Breast feeding, or actively trying to be come pregnant
- Patients with Type 1 DM, gestational diabetes or secondary diabetes
- FPG levels in the range : ≥ 270mg/dL HbA1c : < 7.0, >12.0%
- Patient who take the medicine which may affect to blood sugar control (i.e.systemic glucocorticoid)
- Patients with diabetic complications or the history of a case that would affect to efficacy and safety evaluation (i.e. Thyroid disorder, Cushing's Syndrome, Multiple ovarian cystoma, pheochromocytoma)
- Patients with Chronic hepatitis, hepatitis B, C (except healthy HBV carrier) or Liver diseases (AST or/and ALT >2 × ULN(upper limit normal))
- Patients with Kidney disorder (Cr>2.0)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
YY-351, PO, 1T tid.
/ Placebo, 1T tid.
|
comparison of different dosages of drug
Other Names:
|
Experimental: 2
YY-351.
PO, 2T bid.
/ Placebo 2T qd.
|
comparison of different dosages of drug
Other Names:
|
Experimental: 3
YY-351, PO, 2T tid.
|
comparison of different dosages of drug
Other Names:
|
Placebo Comparator: 4
Placebo, PO, 2T tid.
|
comparison of different dosages of drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in the fasting plasma glucose and postprandial glucose [after 2 hours, oral glucose tolerance test (OGTT) (75 g)] and HbA1c
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjects achieving a glycemic response defined as ≤ 7.0%
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Decrease of HbA1c > 0.5%
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin]
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Body weight (or body composition)
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Waist girth
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Homeostasis model assessment (HOMA)
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Lipid profile
Time Frame: from baseline to Week 8
|
from baseline to Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
October 20, 2008
First Submitted That Met QC Criteria
November 3, 2009
First Posted (Estimate)
November 4, 2009
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YY351-1
- YY-351-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on YY-351/Placebo
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownMantle Cell Lymphoma | Marginal Zone Lymphoma | Lymphoplasmacytic Lymphoma | Diffuse Large B Cell Lymphoma | Small Lymphocytic Lymphoma
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownRelapsed or Refractory Peripheral T-Cell LymphomaChina
-
Shanghai YingLi Pharmaceutical Co. Ltd.Not yet recruiting
-
Ruijin HospitalTianjin Medical University Cancer Institute and HospitalNot yet recruitingFocus on the Lymphoma Including B/T-cell LymphomaChina
-
Shanghai YingLi Pharmaceutical Co. Ltd.Not yet recruitingEffectiveness,Safety,Thymic Cancer
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownLymphoma, FollicularChina
-
Chong Kun Dang PharmaceuticalUnknownOcular Hypertension | Primary Open-angle GlaucomaKorea, Republic of
-
Shanghai YingLi Pharmaceutical Co. Ltd.RecruitingPeripheral T/NK Cell Lymphoma (R/R PTCL)United States
-
University of CopenhagenEC-FP6 (contract number: LHM-CT-2003-503041); Aditech Pharma ABCompleted
-
French Innovative Leukemia OrganisationAcute Leukemia French Association; French Intergroup of Myeloproliferative...RecruitingAcute Myeloid Leukemia | Myeloproliferative SyndromeFrance