NCT00363948

Brief Summary

The purpose of this study is to 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 and metformin as monotherapy

Trial Health

80
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at below P25 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 13, 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 (3)

  • HbA1c

    12 weeks

  • safety

    52 weeks

  • tolerability

    52 weeks

Secondary Outcomes (1)

  • Plasma glucose

    12 weeks

Study Arms (2)

P

PLACEBO COMPARATOR
Drug: Placebo

E

EXPERIMENTAL
Drug: Sitagliptin phosphate

Interventions

PlaceboDRUG

Double-blind period (12 wk); Placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

P
Sitagliptin phosphateDRUG

Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

E

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy

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

Hokuriku Region

Hokuriku, Japan

Location

Kanto Region

Kanto, Japan

Location

Kinki Region

Kinki, Japan

Location

Kyushu Region

Kyushu, Japan

Location

Tohoku Region

Tōhoku, Japan

Location

Related Publications (1)

  • Kadowaki T, Tajima N, Odawara M, Nishii M, Taniguchi T, Ferreira JC. Addition of sitagliptin to ongoing metformin monotherapy improves glycemic control in Japanese patients with type 2 diabetes over 52 weeks. J Diabetes Investig. 2013 Mar 18;4(2):174-81. doi: 10.1111/jdi.12001. Epub 2012 Oct 22.

    PMID: 24843649DERIVED

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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
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 13, 2012

Record last verified: 2012-06

Locations

JP(8)