Back to resultsPilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ONO-5129
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring ONO-5129, type 2 diabetes mellitus
Eligibility Criteria
Inclusion Criteria: Fasting Blood Glucose 126-250mg/dL HbA1c 6.5-11% Exclusion Criteria: Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization History of myocardial infarction, coronary artery surgery Other eligibility criteria as specified in the study protocol
Sites / Locations
- Kanto Region
- Kyusyu Region
Outcomes
Primary Outcome Measures
Fasting Blood Glucose at week 8
Secondary Outcome Measures
Other glycemic control parameters (e.g., HbA1c, glycoalbumin)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00335712
Brief Title
Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Official Title
Phase II Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
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 purpose of this study is to evaluate the efficacy, safety and pharmacokinetics 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
Type 2 Diabetes Mellitus
Keywords
ONO-5129, type 2 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ONO-5129
Primary Outcome Measure Information:
Title
Fasting Blood Glucose at week 8
Secondary Outcome Measure Information:
Title
Other glycemic control parameters (e.g., HbA1c, glycoalbumin)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fasting Blood Glucose 126-250mg/dL
HbA1c 6.5-11%
Exclusion Criteria:
Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
History of myocardial infarction, coronary artery surgery
Other eligibility criteria as specified in the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader, Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Kanto Region
City
Kanto
Country
Japan
Facility Name
Kyusyu Region
City
Kyusyu
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
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