- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00854035
MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus
June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd
A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
266
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
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Chugoku, Japan
- Chugoku region
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Hokuriku, Japan
- Hokuriku region
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Kanto, Japan
- Kanto region
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Kinki, Japan
- Kinki region
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Kyushu, Japan
- Kyushu region
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Tohoku, Japan
- Tohoku region
-
-
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 insulin 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 (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
Double-blind period (16 wk); placebo 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 50 mg QD to 100 mg QD
|
PLACEBO_COMPARATOR: P
|
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
Double-blind period (16 wk); placebo 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 50 mg QD to 100 mg QD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: 16 weeks
|
16 weeks
|
Safety and Tolerability
Time Frame: 16 weeks and 52 weeks
|
16 weeks and 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2 hour post-meal glucose
Time Frame: 16 weeks
|
16 weeks
|
Fasting plasma glucose
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Seki Akiteru, First Division Clinical Development Planning I
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 Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
February 27, 2009
First Submitted That Met QC Criteria
February 27, 2009
First Posted (ESTIMATE)
March 2, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 14, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
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-5435-15
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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