MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

MSD K.K.

Information provided by (Responsible Party):

Ono Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT01517321

First received: November 2, 2011

Last updated: December 28, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2011

Last Updated Date

December 28, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability [ Time Frame: 12 weeks and 52 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01517321 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
2-hour postmeal glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

Official Title ^ICMJE

MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: MK-0431/ONO-5435
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.
Drug: Placebo, MK-0431/ONO-5435
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.

Study Arm (s)

Experimental: E
Intervention: Drug: MK-0431/ONO-5435
Placebo Comparator: P
Intervention: Drug: Placebo, MK-0431/ONO-5435

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy

Exclusion Criteria:

Patients with Type 1 Diabetes Mellitus

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01517321

Other Study ID Numbers ^ICMJE

ONO-5435-17, Japic CTI-111668

Has Data Monitoring Committee

Not Provided

Responsible Party

Ono Pharmaceutical Co. Ltd

Study Sponsor ^ICMJE

Ono Pharmaceutical Co. Ltd

Collaborators ^ICMJE

MSD K.K.

Investigators ^ICMJE

Study Chair:

Akiteru Seki

First Division Clinical Development Planning 1

Information Provided By

Ono Pharmaceutical Co. Ltd

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top