Overview

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