Overview

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Treatments:
Canagliflozin
Glucagon
Glucagon-Like Peptide 1
Criteria
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