Tofogliflozin GLP-1 Analogue Combination Trial

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kowa Company, Ltd.
• Collaborator: Sanofi
• Treatments: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol; Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)

• The subject with hemoglobin A1c ≧7.5% - <10.5 %

• The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test

Exclusion Criteria:

• The subject with type 1 diabetes mellitus

• The subject with Pregnancy or lactation

• The subject with Fasting Plasma Glucose ≧ 270 mg/dl

• The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening

• The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months

• The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women

• The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility

• The subject has received treatment with another investigational product or non-approved drug 3 months before screening

• The subject with history of Tofogliflozin therapy

• The subject with estimated glomerular filtration rate of <30 mL/min/1.73 m^2

• The subject who frequently experiencing orthostatic hypotension

• The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg

• The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug