- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02227849
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus
April 2, 2019 updated by: Mitsubishi Tanabe Pharma Corporation
An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to GLP-1 Analogue in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control.
The patients will receive TA-7284 100mg orally for 52 weeks.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 4
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
-
-
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Chubu, Japan
- Reserch site
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Hokkaido, Japan
- Reserch site
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Kanto, Japan
- Reserch site
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Kinki, Japan
- Reserch site
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-
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:
- Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12 weeks before administration of investigational dug
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- Patients with HbA1c of ≥7.0% and <10.5%
- 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 mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)
- Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
- Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg
- Patients with serious renal or hepatic disease
- Patients with eGFR of <45 mL/min/1.73 m2
- Patients who are the excessive alcohol addicts
- Patients requiring insulin therapy
- Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Canagliflozin (TA-7284) +GLP-1 analogue
|
The patients will receive Canagliflozin orally for 52 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time Frame: 52 Weeks
|
52 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Percentage of HbA1c
Time Frame: Baseline, 52 Weeks
|
Baseline, 52 Weeks
|
Change in Fasting Plasma Glucose
Time Frame: Baseline, 52 Weeks
|
Baseline, 52 Weeks
|
Percentage Change in Body Weight
Time Frame: Baseline, 52 Weeks
|
Baseline, 52 Weeks
|
Change in Blood Pressure
Time Frame: Baseline, 52 Weeks
|
Baseline, 52 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Nobuya Inagaki, Professor, Kyoto University, Graduate School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
August 26, 2014
First Submitted That Met QC Criteria
August 26, 2014
First Posted (Estimate)
August 28, 2014
Study Record Updates
Last Update Posted (Actual)
April 10, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA-7284-12
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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