Status:
COMPLETED
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02227849
Start Date
August 1 2014
End Date
March 1 2016
Last Update
January 8 2026
Active Locations (4)
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1
Reserch site
Chūbu, Japan
2
Reserch site
Hokkaido, Japan
3
Reserch site
Kanto, Japan
4
Reserch site
Kinki, Japan