NCT00854035

Brief Summary

This Phase III clinical trial will examine the efficacy, safety, and tolerability of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
266

participants targeted

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

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

February 27, 2009

Last Update Submit

June 12, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

MK-0431/ONO-5435Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    16 weeks

  • Safety and Tolerability

    16 weeks and 52 weeks

Secondary Outcomes (2)

  • 2 hour post-meal glucose

    16 weeks

  • Fasting plasma glucose

    16 weeks

Study Arms (2)

E

EXPERIMENTAL
Drug: MK-0431/ONO-5435

P

PLACEBO COMPARATOR
Drug: MK-0431/ONO-5435

Interventions

MK-0431/ONO-5435DRUG

Double-blind period (16 wk); 50 mg QD. The double-blind period will be followed by a 36 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50mg QD to 100mg QD

E

Eligibility Criteria

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

You may qualify if:

  • Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy

You may not qualify if:

  • Patients with Type 1 Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chugoku Region

Chugoku, Japan

Location

Chubu Region

Chūbu, 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Seki Akiteru

    First Division Clinical Development Planning I

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2010

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

JP(7)