NCT00363844

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

8 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

August 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1.5 years

First QC Date

August 11, 2006

Last Update Submit

June 12, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

MK-0431ONO-5435Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • safety

    52 weeks

  • tolerability

    52 weeks

Secondary Outcomes (2)

  • HbA1c

    52 weeks

  • Plasma glucose

    52 weeks

Study Arms (1)

E

EXPERIMENTAL
Drug: Sitagliptin phosphate

Interventions

Sitagliptin phosphateDRUG

50 mg QD or 100 mg QD for 12 months

E

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes mellitus on diet and exercise therapy

You may not qualify if:

  • Patients with type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chugoku Region

Chugoku, Japan

Location

Chubu Region

Chūbu, Japan

Location

Hokkaido Region

Hokkaido, Japan

Location

Kanto Region

Kanto, Japan

Location

Kinki Region

Kinki, Japan

Location

Kyushu Region

Kyushu, Japan

Location

Shikoku Region

Shikoku, Japan

Location

Tohoku Region

Tōhoku, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Mikio Nishii

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2008

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

JP(8)