Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

Phase II Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335712

Enrollment

Registered

2006-06-12

Start date

2006-06-30

Completion date

Unknown

Last updated

2012-06-13

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

Conditions

Type 2 Diabetes Mellitus

Keywords

ONO-5129, type 2 diabetes mellitus

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.

Interventions

DRUGONO-5129

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to 74 Years

Healthy volunteers

Inclusion criteria

1. Fasting Blood Glucose 126-250mg/dL 2. HbA1c 6.5-11%

Exclusion criteria

1. Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization 2. History of myocardial infarction, coronary artery surgery 3. Other eligibility criteria as specified in the study protocol

Design outcomes

Primary

Measure	Time frame
Fasting Blood Glucose at week 8	—

Secondary

Measure	Time frame
Other glycemic control parameters (e.g., HbA1c, glycoalbumin)	—

Countries

Japan

Outcome results

None listed

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