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

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:
  • Ginsam
Experimental: 2
YY-351. PO, 2T bid. / Placebo 2T qd.
comparison of different dosages of drug
Other Names:
  • Ginsam
Experimental: 3
YY-351, PO, 2T tid.
comparison of different dosages of drug
Other Names:
  • Ginsam
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.

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

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

Clinical Trials on YY-351/Placebo

3
Subscribe