Type 2 Diabetes Mellitus
Conditions
Brief 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.
Interventions
DRUGTofogliflozin
DRUGGLP-1 analogue
Sponsors
Sanofi
Kowa Company, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction | baseline and Week 52 |
| Change from Baseline in HbA1c at 52 weeks | Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Blood pressure | baseline and week 52 |
| Change in Uric Acid | baseline and week 52 |
| Change in Total cholesterol | baseline and week 52 |
| Change in Fasting plasma glucose | baseline and week 52 |
| Change in LDL-C | baseline and week 52 |
| Change in non HDL-C | baseline and week 52 |
| Change in Free Fatty Acid | baseline and week 52 |
| Change in HDL-C | baseline and week 52 |
| Change in Body Weight | baseline and week 52 |
Countries
Japan
Outcome results
None listed