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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00212641
• Lead Sponsor: Ono Pharma USA Inc

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Primary Completion: 2007-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic parameters at all time points

Trial Locations

Locations (67)

Apex Clinical Trials, Inc.; 🇺🇸 Birmingham, Alabama, United States

Greystone Medical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Med Search, LLC; 🇺🇸 Calera, Alabama, United States

Medical Affiliated Research Center; 🇺🇸 Huntsville, Alabama, United States

Clinic of Physicians and Surgeons; 🇺🇸 Mesa, Arizona, United States

Horizon Clinical Research Associates; 🇺🇸 Mesa, Arizona, United States

Cochise Clinical Research; 🇺🇸 Sierra Vista, Arizona, United States

Sagebrush Medical Plaza, Department of Family Medicine; 🇺🇸 Bakersfield, California, United States

Family Medical Center; 🇺🇸 Foothill Ranch, California, United States

Prime-Care Clinical Research; 🇺🇸 Mission Viejo, California, United States

Scroll for more (57 remaining)