Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
teneligliptin
glinide
biguanide
alpha-glucosidase inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- Patients whose HbA1c is between 6.5% - 10.0%
- Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Exclusion Criteria:
- Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients who are accepting treatments of arrhythmias
- Patients with serious diabetic complications
- Patients who are habitual excessive alcohol consumption.
- Patients with severe hepatic disorder or severe renal disorder.
- Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
teneligliptin
teneligliptin and glinide
teneligliptin and biguanide
teneligliptin and alpha-glucosidase inhibitor
Arm Description
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Secondary Outcome Measures
Change From Baseline in HbA1c at Week 52
Change From Baseline in Fasting Plasma Glucose at Week 52
Change From Baseline in Fasting Glucagon at Week 52
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Full Information
NCT ID
NCT01301833
First Posted
February 14, 2011
Last Updated
October 15, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01301833
Brief Title
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Official Title
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
462 (Actual)
8. Arms, Groups, and Interventions
Arm Title
teneligliptin
Arm Type
Experimental
Arm Description
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Arm Title
teneligliptin and glinide
Arm Type
Experimental
Arm Description
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
Arm Title
teneligliptin and biguanide
Arm Type
Experimental
Arm Description
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
Arm Title
teneligliptin and alpha-glucosidase inhibitor
Arm Type
Experimental
Arm Description
teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Intervention Type
Drug
Intervention Name(s)
teneligliptin
Other Intervention Name(s)
MP-513
Intervention Type
Drug
Intervention Name(s)
glinide
Intervention Type
Drug
Intervention Name(s)
biguanide
Intervention Type
Drug
Intervention Name(s)
alpha-glucosidase inhibitor
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 52
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Fasting Plasma Glucose at Week 52
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Fasting Glucagon at Week 52
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Time Frame
Baseline and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Exclusion Criteria:
Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Kadowaki, Professor
Organizational Affiliation
Tokyo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
City
Chitose-shi
State/Province
Hokkaidou
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25861982
Citation
Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.
Results Reference
result
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Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
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