Type 2 diabetes mellitus
Conditions
Interventions
Orally administration of 100mg canagliflozin once a day, pre or post breakfast for 12months
Sponsors
Kanagawa Physicians Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years and older at providing consent 2) Outpatients providing written informed consent 3) Male and Female 4) Poorly efected only diet/exercise therapy or poorly controlled glucose level whereas undergoing diet/exercise therapy in addition to oral antidiabetics (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) at least 12 weeks 5) 10.0%>=HbA1c(NGSP)>=6.5% 6) Possibility of answer for diet/exercise therapy and DTSQ(Diabetes Treatment Satisfaction Questionnaire)
Exclusion criteria
Exclusion criteria: 1) Received SGLT 2 inhibitors within 6 months before providing consent 2) Type 1 diabetes 3) Severe ketosis, diabetic coma or precoma within 6 months 4) Treatment with Insulin preparation and/or GLP -1 receptor agonist 5) Severe infection, been pre-/post-surgery, and serious trauma 6) Severe hepatic dysfunction 7) Moderate or severe renal dysfunction 8) Hypersensitivity to any ingredient of the study drug 9) Urinary tract infection and genital infection 10) Contraindications to undergoing oral hypoglycemic agents (DPP-4 inhibitor, Sulfonylurea, Metformin etc.) 11) Enrolled in other current clinical trials 12) Pregnancy, nursing and possibility of pregnant or plan to pregnant 13) Considered as inadequate by the principal investigator or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change in HbA1c from baseline to the end of treatment period - Change in score of Diabetes Treatment Satisfaction by using DTSQ(Diabetes Treatment Satisfaction Questionnaire) from baseline to the end of treatment period. -Change in dietary habits and/or exercise habits by using FFQg(Food Frequency Questionnaire Based on Food Groups)from baseline to the end of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Change or change rate in following items from baseline to the end of treatment period Fasting plasma glucose(or Casual plasma glucose), Insulin(Only fasting), Weight, BMI, Waist circumference, Body composition, Blood pressure(systolic blood pressure, diastolic blood pressure), Lipid parameter[total cholesterol(TC), HDL-C, LDL-C,non HDL-C, triglyceride(TG), Free fatty acid(FFA)], LDL-C/ HDL-C ratio, Leptin | — |
Countries
Japan
Contacts
Public ContactMasako Kusano
I'cros Japan Co.,Ltd Drug Information Support Department
Outcome results
None listed