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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212641

Enrollment

105

Registered

2005-09-21

Start date

2005-06-30

Completion date

Unknown

Last updated

2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

Interventions

DRUGONO-5129

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Fasting Blood Glucose at 8 weeks	—

Secondary

Measure	Time frame
Pharmacodynamic parameters at all time points	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026