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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONO-5129
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 Diabetes Mellitus FBG level > 140 mg/dL and < 270 mg/dL Fasting TG level < 500 mg/dL BMI of 22 to 40 kg/m2, inclusive Other Inclusion criteria as specified in the study protocol Exclusion Criteria: Previous participation in an ONO-5129 protocol Previous treatment with TZD agents or other current antidiabetics History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe) Other exclusion criteria as specified in the study protocol

Sites / Locations

  • Apex Clinical Trials, Inc.
  • Greystone Medical Research, LLC
  • Med Search, LLC
  • Medical Affiliated Research Center
  • Clinic of Physicians and Surgeons
  • Horizon Clinical Research Associates
  • Cochise Clinical Research
  • Sagebrush Medical Plaza, Department of Family Medicine
  • Family Medical Center
  • Prime-Care Clinical Research
  • Encompass Clinical Research
  • Orange County Research Center
  • Quality Care Medical Center
  • Arapahoe Internal Medicine
  • Institute Diabetes and Metabolic Disease
  • Alliance Medical Reserach Group, Inc.
  • Personal Physician Care
  • Century Clinical Research, Inc
  • Innovative Research of West Florida
  • Cardiovascular Center of Sarasota
  • Executive Health and Research Associates, Inc.
  • Capital City Family Medicine
  • Orthopedic Health Care Clinic
  • Sonora Clinical Research
  • Cedar-Crosse Research Center
  • Chicago Research Center, Inc.
  • Heart of America Research
  • Dolby Research, LLC
  • Acadia Clinical Research, LLC
  • Franklin Square Hospital Center
  • Centennial Medical Group
  • Professional Clinical Reserach -Great Lakes Family Care
  • Synergy Medical Education Alliance
  • Medex Healthcare Research, Inc
  • Mercury Street Medical
  • Specialty Medical Center
  • Bassett Healthcare
  • DiGiovanna Family Care Center
  • United Physicians Group - Endocrine Division
  • Winthrop University Hospital
  • New Horizons Clinical Research
  • Wells Institute for Health Awareness
  • Fallen Timbers Internal Medicine LLC
  • COR Clinical Reserch, LLC
  • Cllinical Research Consultants
  • Covance Clinical Research Unit, Inc
  • Michael A. Azorr, M.D.
  • Keystone Clinical Solutions
  • Southeastern PA Medical Institute
  • Greenand Seidner Family Practice
  • Thomas Jefferson University Div of Endocrinology
  • Founders Medical Practice
  • Research Endeavors
  • Hillcrest Clinical Research LLC
  • Spartanburg Medical Research
  • John Joseph, MD PA
  • Renaissance Clinical Research
  • MCA Research
  • Southwest Houston Research, LTD
  • Professional for Clinical Research
  • Research Across America
  • Benjamin Garwood Research
  • WellMed at Northern Hills
  • Diabetes and Glandular Disease Research Associates
  • Diabetes and Glandular Disease - Westside office
  • Liberty Research Center
  • Hyperion Clinical Trials, Inc.

Outcomes

Primary Outcome Measures

Fasting Blood Glucose at 8 weeks

Secondary Outcome Measures

Pharmacodynamic parameters at all time points

Full Information

First Posted
September 12, 2005
Last Updated
October 10, 2012
Sponsor
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00212641
Brief Title
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Official Title
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ONO-5129
Primary Outcome Measure Information:
Title
Fasting Blood Glucose at 8 weeks
Secondary Outcome Measure Information:
Title
Pharmacodynamic parameters at all time points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes Mellitus FBG level > 140 mg/dL and < 270 mg/dL Fasting TG level < 500 mg/dL BMI of 22 to 40 kg/m2, inclusive Other Inclusion criteria as specified in the study protocol Exclusion Criteria: Previous participation in an ONO-5129 protocol Previous treatment with TZD agents or other current antidiabetics History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe) Other exclusion criteria as specified in the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph G Bisaha, Ph.D.
Organizational Affiliation
Ono Pharma USA Inc
Official's Role
Study Director
Facility Information:
Facility Name
Apex Clinical Trials, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Greystone Medical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Med Search, LLC
City
Calera
State/Province
Alabama
ZIP/Postal Code
35040
Country
United States
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinic of Physicians and Surgeons
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
Horizon Clinical Research Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Cochise Clinical Research
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
Sagebrush Medical Plaza, Department of Family Medicine
City
Bakersfield
State/Province
California
ZIP/Postal Code
93305
Country
United States
Facility Name
Family Medical Center
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Prime-Care Clinical Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Quality Care Medical Center
City
Vista
State/Province
California
ZIP/Postal Code
92084
Country
United States
Facility Name
Arapahoe Internal Medicine
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Institute Diabetes and Metabolic Disease
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Alliance Medical Reserach Group, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33755
Country
United States
Facility Name
Personal Physician Care
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Century Clinical Research, Inc
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Innovative Research of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Executive Health and Research Associates, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Capital City Family Medicine
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Orthopedic Health Care Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Sonora Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Chicago Research Center, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Heart of America Research
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Dolby Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Acadia Clinical Research, LLC
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Professional Clinical Reserach -Great Lakes Family Care
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Synergy Medical Education Alliance
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Medex Healthcare Research, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Specialty Medical Center
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
Facility Name
Bassett Healthcare
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
DiGiovanna Family Care Center
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
United Physicians Group - Endocrine Division
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45252
Country
United States
Facility Name
Wells Institute for Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fallen Timbers Internal Medicine LLC
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
COR Clinical Reserch, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Cllinical Research Consultants
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Covance Clinical Research Unit, Inc
City
Portland
State/Province
Oregon
ZIP/Postal Code
92739
Country
United States
Facility Name
Michael A. Azorr, M.D.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Keystone Clinical Solutions
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Southeastern PA Medical Institute
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
Greenand Seidner Family Practice
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Thomas Jefferson University Div of Endocrinology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Founders Medical Practice
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Research Endeavors
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15238
Country
United States
Facility Name
Hillcrest Clinical Research LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
John Joseph, MD PA
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Renaissance Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
MCA Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Southwest Houston Research, LTD
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Professional for Clinical Research
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Benjamin Garwood Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78216
Country
United States
Facility Name
WellMed at Northern Hills
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Diabetes and Glandular Disease Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diabetes and Glandular Disease - Westside office
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78237
Country
United States
Facility Name
Liberty Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hyperion Clinical Trials, Inc.
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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