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A Dose-Finding, Efficacy and Safety Study of YY-351 in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008163
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yuyu Pharma, Inc.

Brief Summary:
The purpose of this trial is to determine the dosage selected and to evaluate the efficacy and safety of YY-351.

Condition or disease Intervention/treatment Phase
Diabetes Drug: YY-351/Placebo Drug: YY-351 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Efficacy and Safety of YY-351 in Patients With Type 2 Diabetes Mellitus
Study Start Date : January 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
YY-351, PO, 1T tid. / Placebo, 1T tid.
Drug: YY-351/Placebo
comparison of different dosages of drug
Other Name: Ginsam

Experimental: 2
YY-351. PO, 2T bid. / Placebo 2T qd.
Drug: YY-351/Placebo
comparison of different dosages of drug
Other Name: Ginsam

Experimental: 3
YY-351, PO, 2T tid.
Drug: YY-351
comparison of different dosages of drug
Other Name: Ginsam

Placebo Comparator: 4
Placebo, PO, 2T tid.
Drug: Placebo
comparison of different dosages of drug




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Subjects achieving a glycemic response defined as ≤ 7.0% [ Time Frame: from baseline to Week 8 ]
  2. Decrease of HbA1c > 0.5% [ Time Frame: from baseline to Week 8 ]
  3. Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin] [ Time Frame: from baseline to Week 8 ]
  4. Body weight (or body composition) [ Time Frame: from baseline to Week 8 ]
  5. Waist girth [ Time Frame: from baseline to Week 8 ]
  6. Homeostasis model assessment (HOMA) [ Time Frame: from baseline to Week 8 ]
  7. Lipid profile [ Time Frame: from baseline to Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008163


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Bungdang-Gu, Korea, Republic of, 463-707
Sponsors and Collaborators
Yuyu Pharma, Inc.
Investigators
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Principal Investigator: Soo Lim, MD,PHD Seoul National University Bundang Hospital
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Responsible Party: Yuyu Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01008163    
Other Study ID Numbers: YY351-1
YY-351-4
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by Yuyu Pharma, Inc.:
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases