A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

October 10, 2012 updated by: Ono Pharma USA Inc

Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

105

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Greystone Medical Research, LLC
      • Birmingham, Alabama, United States, 35209
        • Apex Clinical Trials, Inc.
      • Calera, Alabama, United States, 35040
        • Med Search, LLC
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center
    • Arizona
      • Mesa, Arizona, United States, 85201
        • Clinic of Physicians and Surgeons
      • Mesa, Arizona, United States, 85206
        • Horizon Clinical Research Associates
      • Sierra Vista, Arizona, United States, 85635
        • Cochise Clinical Research
    • California
      • Bakersfield, California, United States, 93305
        • Sagebrush Medical Plaza, Department of Family Medicine
      • Foothill Ranch, California, United States, 92610
        • Family Medical Center
      • Mission Viejo, California, United States, 92691
        • Prime-Care Clinical Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • Vista, California, United States, 92084
        • Quality Care Medical Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Arapahoe Internal Medicine
    • Delaware
      • Newark, Delaware, United States, 19713
        • Institute Diabetes and Metabolic Disease
    • Florida
      • Clearwater, Florida, United States, 33755
        • Alliance Medical Reserach Group, Inc.
      • Delray Beach, Florida, United States, 33445
        • Personal Physician Care
      • Holly Hill, Florida, United States, 32117
        • Century Clinical Research, Inc
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates, Inc.
    • Idaho
      • Boise, Idaho, United States, 83702
        • Sonora Clinical Research
      • Boise, Idaho, United States, 83702
        • Orthopedic Health Care Clinic
      • Boise, Idaho, United States, 83702
        • Capital City Family Medicine
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center, Inc.
    • Kansas
      • Shawnee, Kansas, United States, 66216
        • Heart of America Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Dolby Research, LLC
    • Maine
      • Bangor, Maine, United States, 04401
        • Acadia Clinical Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital Center
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Reserach -Great Lakes Family Care
      • Saginaw, Michigan, United States, 48602
        • Synergy Medical Education Alliance
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Medex Healthcare Research, Inc
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical
    • Nevada
      • Pahrump, Nevada, United States, 89048
        • Specialty Medical Center
    • New York
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare
      • Great Neck, New York, United States, 11021
        • DiGiovanna Family Care Center
      • Great Neck, New York, United States, 11021
        • United Physicians Group - Endocrine Division
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45252
        • New Horizons Clinical Research
      • Kettering, Ohio, United States, 45429
        • Wells Institute for Health Awareness
      • Maumee, Ohio, United States, 43537
        • Fallen Timbers Internal Medicine LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Reserch, LLC
    • Oregon
      • Medford, Oregon, United States, 97504
        • Cllinical Research Consultants
      • Portland, Oregon, United States, 92739
        • Covance Clinical Research Unit, Inc
      • Portland, Oregon, United States, 97232
        • Michael A. Azorr, M.D.
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical Solutions
      • Havertown, Pennsylvania, United States, 19083
        • Southeastern PA Medical Institute
      • Lansdale, Pennsylvania, United States, 19446
        • Greenand Seidner Family Practice
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Div of Endocrinology
      • Philadelphia, Pennsylvania, United States, 19152
        • Founders Medical Practice
      • Pittsburg, Pennsylvania, United States, 15238
        • Research Endeavors
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Clinical Research LLC
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Texas
      • Carrollton, Texas, United States, 75007
        • John Joseph, MD PA
      • Dallas, Texas, United States, 75235
        • Renaissance Clinical Research
      • Houston, Texas, United States, 77024
        • MCA Research
      • Houston, Texas, United States, 77074
        • Southwest Houston Research, Ltd
      • Plano, Texas, United States, 75093
        • Research Across America
      • Plano, Texas, United States, 75093
        • Professional for Clinical Research
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Research Associates
      • San Antonio, Texas, United States, 78216
        • Benjamin Garwood Research
      • San Antonio, Texas, United States, 78217
        • Wellmed at Northern Hills
      • San Antonio, Texas, United States, 78237
        • Diabetes and Glandular Disease - Westside office
    • Washington
      • Tacoma, Washington, United States, 98405
        • Liberty Research Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Hyperion Clinical Trials, Inc.

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 Diabetes Mellitus
  2. FBG level > 140 mg/dL and < 270 mg/dL
  3. Fasting TG level < 500 mg/dL
  4. BMI of 22 to 40 kg/m2, inclusive
  5. Other Inclusion criteria as specified in the study protocol

Exclusion Criteria:

  1. Previous participation in an ONO-5129 protocol
  2. Previous treatment with TZD agents or other current antidiabetics
  3. History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
  4. Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
  5. Other exclusion criteria as specified in the study protocol

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting Blood Glucose at 8 weeks

Secondary Outcome Measures

Outcome Measure
Pharmacodynamic parameters at all time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Investigators

  • Study Director: Joseph G Bisaha, Ph.D., Ono Pharma USA Inc

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

June 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-5129POU006

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.

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