NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Tofogliflozin GLP-1 Analogue Combination Trial
Tofogliflozin GLP-1 Analogue Combination Trial
CompletedPhase 4
Sponsor: Kowa Company, Ltd.
Conditions: Type 2 Diabetes Mellitus
Interventions: Tofogliflozin, GLP-1 analogue
Countries: Japan
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.
Eligibility overview
Sex: ALL
Age: 20 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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
Locations (11)
- Atsuta-ku, Aichi-ken, Japan
- Minato-ku, Aichi-ken, Japan
- Kisarazu, Chiba, Japan
- Annaka, Gunma, Japan
- Naka, Ibaraki, Japan
- Sagamihara, Kanagawa, Japan
- Kasaoka, Okayama-ken, Japan
- Shimono, Tochigi, Japan
- Adachi-ku, Tokyo, Japan
- Chuo-ku, Tokyo, Japan
- Mitaka, Tokyo, Japan