Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2015-08-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tofogliflozin ＋GLP-1 analogue
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
Tofogliflozin
GLP-1 analogue
Interventions
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Tofogliflozin
GLP-1 analogue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Kowa Company, Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K. Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526. doi: 10.1111/jdi.13066. Epub 2019 May 28.
Related Links
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Related Info
Other Identifiers
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TOFOGL07279
Identifier Type: OTHER
Identifier Source: secondary_id
DEBT02
Identifier Type: -
Identifier Source: org_study_id