Back to resultsA Study of OPC-262 in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Type 2
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-262 2.5 mg
OPC-262 5 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Type 2
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes patients with HbA1C above 6.5% and below 10%
- Patients who are capable of giving informed consent
- Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
Exclusion Criteria:
- Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetic coma
- Patients with poorly-controlled hypertension
- Patients with heart failure
- Patients with a complication of active hepatitis or hepatic cirrhosis
- Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
- Patients with a history or complication of malignant tumor
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
OPC-262 2.5 mg
OPC-262 5 mg
Placebo
Arm Description
orally administered once daily for 24 weeks
orally administered once daily for 24 weeks
orally administered once daily for 24 weeks
Outcomes
Primary Outcome Measures
Changes in HbA1C from baseline
Secondary Outcome Measures
Changes in fasting blood glucose (FBG) from baseline
Changes in 2 hour postprandial blood glucose (PPG) from baseline
Changes in 3 hour PPG AUC from baseline
Full Information
NCT ID
NCT00997282
First Posted
October 16, 2009
Last Updated
January 6, 2014
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00997282
Brief Title
A Study of OPC-262 in Patients With Type 2 Diabetes
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OPC-262 2.5 mg
Arm Type
Experimental
Arm Description
orally administered once daily for 24 weeks
Arm Title
OPC-262 5 mg
Arm Type
Experimental
Arm Description
orally administered once daily for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
orally administered once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
OPC-262 2.5 mg
Intervention Description
orally administered once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
OPC-262 5 mg
Intervention Description
orally administered once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally administered once daily for 24 weeks
Primary Outcome Measure Information:
Title
Changes in HbA1C from baseline
Time Frame
Week 24 (LOCF)
Secondary Outcome Measure Information:
Title
Changes in fasting blood glucose (FBG) from baseline
Time Frame
Week 24
Title
Changes in 2 hour postprandial blood glucose (PPG) from baseline
Time Frame
Week 24
Title
Changes in 3 hour PPG AUC from baseline
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes patients with HbA1C above 6.5% and below 10%
Patients who are capable of giving informed consent
Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
Exclusion Criteria:
Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
Patients with a medical history of diabetic coma
Patients with poorly-controlled hypertension
Patients with heart failure
Patients with a complication of active hepatitis or hepatic cirrhosis
Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
Patients with a history or complication of malignant tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaatsuhisa Saito
Organizational Affiliation
OPCJ
Official's Role
Study Chair
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Kansai Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of OPC-262 in Patients With Type 2 Diabetes
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