NCT01517321

Brief Summary

This Phase III clinical trial will examine the safety, tolerability, and efficacy 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 rapid-acting insulin secretagogue monotherapy.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

November 2, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

First QC Date

November 2, 2011

Last Update Submit

July 7, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability

    12 weeks and 52 weeks

Secondary Outcomes (3)

  • HbA1c

    12 weeks

  • 2-hour postmeal glucose

    12 weeks

  • Fasting plasma glucose

    12 weeks

Study Arms (2)

E

EXPERIMENTAL
Drug: MK-0431/ONO-5435

P

PLACEBO COMPARATOR
Drug: Placebo, MK-0431/ONO-5435

Interventions

MK-0431/ONO-5435DRUG

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

E
Placebo, MK-0431/ONO-5435DRUG

Double-blind period (12 wks); 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 to 100 mg QD.

P

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 rapid-acting insulin secretagogue monotherapy

You may not qualify if:

  • Patients with Type 1 Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chugoku Region Clinical Site

Chugoku, Japan

Location

Chubu Region Clinical Site

Chūbu, Japan

Location

Kanto Region Clinical Site

Kanto, Japan

Location

Kinki Region Clinical Site

Kinki, Japan

Location

Kyusyu Region Clinical Site

Kyusyu, Japan

Location

Tohoku Region Clinical Site

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

  • Akiteru Seki

    First Division Clinical Development Planning 1

    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

November 2, 2011

First Posted

January 25, 2012

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations

JP(6)