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Tofogliflozin GLP-1 Analogue Combination Trial
Tofogliflozin GLP-1 Analogue Combination Trial

NCT02537834

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