NCT00335712

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

First QC Date

June 9, 2006

Last Update Submit

June 12, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

ONO-5129type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Fasting Blood Glucose at week 8

Secondary Outcomes (1)

  • Other glycemic control parameters (e.g., HbA1c, glycoalbumin)

Interventions

ONO-5129DRUG

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting Blood Glucose 126-250mg/dL
  • HbA1c 6.5-11%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kanto Region

Kanto, Japan

Location

Kyusyu Region

Kyusyu, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2006

First Posted

June 12, 2006

Study Start

June 1, 2006

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(2)