This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments tofogliflozin, glp-1 analogue
Phase phase 4
Sponsor Kowa Company, Ltd.
Collaborator Sanofi
Start date August 2015
End date July 2017
Trial size 65 participants
Trial identifier NCT02537834, DEBT02, TOFOGL07279


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
tofogliflozin DEBERZA
glp-1 analogue

Primary Outcomes

Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction
time frame: baseline and Week 52
Change from Baseline in HbA1c at 52 weeks
time frame: Week 52

Secondary Outcomes

Change in Fasting plasma glucose
time frame: baseline and week 52
Change in Body Weight
time frame: baseline and week 52
Change in Blood pressure
time frame: baseline and week 52
Change in Uric Acid
time frame: baseline and week 52
Change in Total cholesterol
time frame: baseline and week 52
Change in HDL-C
time frame: baseline and week 52
Change in LDL-C
time frame: baseline and week 52
Change in non HDL-C
time frame: baseline and week 52
Change in Free Fatty Acid
time frame: baseline and week 52

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Kowa Company, Ltd..