Pilot Study of ONO-5129 in Patients With Type 2 Diabetes... | NCT00335712

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

NCT00335712

Sponsor

Ono Pharma USA Inc

Status

Completed

Last Update Posted

Jun 13, 2012Estimated

Enrollment

81Actual

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

ONO-5129

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 9, 2006

First Submission Date that Met QC Criteria

Jun 9, 2006

First Posted Date

Jun 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Name	Type	Description	Arm Group Labels	Other Names
ONO-5129	Drug

Measure	Description	Time Frame
Fasting Blood Glucose at week 8

Measure	Description	Time Frame
Other glycemic control parameters (e.g., HbA1c, glycoalbumin)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Project Leader, Development Planning	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanto Region		Kanto			Japan
Kyusyu Region

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided