Type 2 Diabetes
Conditions
Interventions
Group A: Administer tofogliflozin Patients in this tofogliflozin group orally take tofogliflozin 20 mg once a day before breakfast for 24 weeks.
Group B: Administer glimepiride Patients in t
Sponsors
Japan society for Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Patients with type 2 diabetes 2. Patients who have used a dual treatment of a DPP-4 inhibitor with metformin for 4 weeks or longer until consenting *Those who have not changed the type of DPP-4 inhibitor or metformin as well as the dosage and administration within that time period **The dosage of metformin must be in the range of 500 mg per day or more but no more than 1,500 mg per day 3. Patients with HbA1c 7.0% or higher, and lower than 9.0% at the time of giving their consent 4. Female and male patients at age of 20 or older, and younger than 75 years of age 5. Patients who can give their consent in a written form
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with type 1 diabetes or secondary diabetes 2. Patients who have used antidiabetic medication other than DPP-4 inhibitors or metformin (e.g. insulin, GLP-1 receptor agonist) within the 12 weeks until consenting 3. Patients who have changed the dosage of a diuretic agent or started a new diuretic agent within the 12 weeks until consenting 4. Patients with BMI below 18.5 kg/m2 or BMI 35 kg/m2 or higher at the time of consenting 5. Patients with conditions contraindicated the use of study drugs 6. Patients with a medical history of hypersensitivity to the study drugs 7. Patients with moderate to severe renal function impairment, or at the terminal stage of renal failure (eGFR< 60mL/min/1.73m2) 8. Patients with severe hepatic impairment 9. Patients with a medical history of stroke or cerebral infarction 10. Patients who are currently or possibly pregnant, breastfeeding or planning to be pregnant 11. Patients with moderate to severe heart failure (New York Heart Association [NYHA] functional class III or higher) 12. Patients with urinary tract infection or genital infection 13. Patients currently with a malignancy, or with a medical history of a malignancy (excluding those who are not currently treated for the malignancy or show no redevelopment of it, or a physician assures no relapse during the study period) 14. Patients with other conditions that investigators/physicians think inappropriate to join the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body fat percentage from baseline to the 24th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Examine the following indexes from baseline to the 24th week 1. Change in body composition other than body fat percent (fat mass, lean body mass, muscle mass, amount of body water, body water percentage, estimated bone mass, basal metabolic rate, level of basal metabolism, visceral fat level, leg muscle score, degree of obesity) 2. Change in body weight, abdominal circumstance, BMI 3. Change in indexes related to glycemic control and beta-cell function: HbA1c, blood glucose level, insulin level, C-peptide, glucagon, HOMA-beta, HOMA-R 4. Change in indexes related to lipid metabolism and arteriosclerosis: TC, HDL-C, TG, LDL-C, adiponectin, leptin 5. Indexes related to liver function: AST, ALT, gamma GTP, ketone body (total ketone, acetoacetic acid, beta hydroxybutyric acid), type IV collagen (7S), ferritin, hyaluronic acid 6. Change in indexes related to diabetic renal disease or renal function: serum creatinine, urinary albumin, eGFR 7. Change in uric acid 8. Occurrence rate of any adverse event related to the study drugs 9. Medication adherence | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed