Controlled Study of MK-0431/ONO-5435 in Patients With Typ... | NCT00363844

Studies
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

NCT00363844

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

209Actual

Phase

Phase 3

Conditions

Type 2 Diabetes Mellitus

Interventions

Sitagliptin phosphate

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

Aug 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Not provided

First Submitted Date

Aug 11, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 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 14, 2012Estimated

Description Module

Brief Summary

Determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E	Experimental		Drug: Sitagliptin phosphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin phosphate	Drug	50 mg QD or 100 mg QD for 12 months	E

Measure	Description	Time Frame
safety		52 weeks
tolerability		52 weeks

Measure	Description	Time Frame
HbA1c		52 weeks
Plasma glucose		52 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with type 2 diabetes mellitus on diet and exercise therapy

Exclusion Criteria:

Patients with type 1 diabetes mellitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mikio Nishii	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chugoku Region		Chugoku			Japan
Chubu 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

Intervention Browse Module

MeSH Terms

ID	Term
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided