NCT01008163

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

October 20, 2008

Last Update Submit

February 21, 2019

Conditions

Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the fasting plasma glucose and postprandial glucose [after 2 hours, oral glucose tolerance test (OGTT) (75 g)] and HbA1c

    from baseline to Week 8

Secondary Outcomes (7)

  • Subjects achieving a glycemic response defined as ≤ 7.0%

    from baseline to Week 8

  • Decrease of HbA1c > 0.5%

    from baseline to Week 8

  • Biomarkers [liver function tests (LFT), high-sensitivity C-reactive protein (hsCRP), adiponectin]

    from baseline to Week 8

  • Body weight (or body composition)

    from baseline to Week 8

  • Waist girth

    from baseline to Week 8

  • +2 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

YY-351, PO, 1T tid. / Placebo, 1T tid.

Drug: YY-351/Placebo

2

EXPERIMENTAL

YY-351. PO, 2T bid. / Placebo 2T qd.

Drug: YY-351/Placebo

3

EXPERIMENTAL

YY-351, PO, 2T tid.

Drug: YY-351

4

PLACEBO COMPARATOR

Placebo, PO, 2T tid.

Drug: Placebo

Interventions

YY-351/PlaceboDRUG

comparison of different dosages of drug

Also known as: Ginsam
1
YY-351DRUG

comparison of different dosages of drug

Also known as: Ginsam
3
PlaceboDRUG

comparison of different dosages of drug

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Bungdang-Gu, 463-707, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Soo Lim, MD,PHD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2008

First Posted

November 4, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

KR(1)