- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517321
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
July 7, 2013 updated by: Ono Pharmaceutical Co. Ltd
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chubu, Japan
- Chubu Region Clinical Site
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Chugoku, Japan
- Chugoku Region Clinical Site
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Kanto, Japan
- Kanto Region Clinical Site
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Kinki, Japan
- Kinki Region Clinical Site
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Kyusyu, Japan
- Kyusyu Region Clinical Site
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Tohoku, Japan
- Tohoku Region Clinical Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: E
|
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.
|
PLACEBO_COMPARATOR: P
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks and 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting plasma glucose
Time Frame: 12 weeks
|
12 weeks
|
HbA1c
Time Frame: 12 weeks
|
12 weeks
|
2-hour postmeal glucose
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Akiteru Seki, First Division Clinical Development Planning 1
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 2011
First Submitted That Met QC Criteria
January 20, 2012
First Posted (ESTIMATE)
January 25, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 9, 2013
Last Update Submitted That Met QC Criteria
July 7, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- ONO-5435-17
- Japic CTI-111668 (REGISTRY: Japan Pharmaceutical Information Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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