Back to resultsMK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MK-0431/ONO-5435
Placebo, MK-0431/ONO-5435
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Chubu Region Clinical Site
- Chugoku Region Clinical Site
- Kanto Region Clinical Site
- Kinki Region Clinical Site
- Kyusyu Region Clinical Site
- Tohoku Region Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
E
P
Arm Description
Outcomes
Primary Outcome Measures
Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability
Secondary Outcome Measures
HbA1c
2-hour postmeal glucose
Fasting plasma glucose
Full Information
NCT ID
NCT01517321
First Posted
November 2, 2011
Last Updated
July 7, 2013
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
MSD K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01517321
Brief Title
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
Official Title
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
MSD K.K.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
E
Arm Type
Experimental
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MK-0431/ONO-5435
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo, MK-0431/ONO-5435
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
12 weeks
Title
2-hour postmeal glucose
Time Frame
12 weeks
Title
Fasting plasma glucose
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akiteru Seki
Organizational Affiliation
First Division Clinical Development Planning 1
Official's Role
Study Chair
Facility Information:
Facility Name
Chubu Region Clinical Site
City
Chubu
Country
Japan
Facility Name
Chugoku Region Clinical Site
City
Chugoku
Country
Japan
Facility Name
Kanto Region Clinical Site
City
Kanto
Country
Japan
Facility Name
Kinki Region Clinical Site
City
Kinki
Country
Japan
Facility Name
Kyusyu Region Clinical Site
City
Kyusyu
Country
Japan
Facility Name
Tohoku Region Clinical Site
City
Tohoku
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
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