Type 2 diabetes
Conditions
Interventions
Group A: Canagliflozin add-on to insulin group
Group B: Control (insulin only)
Sponsors
University of Occupational and Environmental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only those patients who meet all of the following criteria are included in this study: 1. T2DM patients who are on insulin monotherapy, or use insulin with DPP-4i, biguanide (BG), thiazolidinedione-based (TZD), or alpha-GI medicine regardless of insulin type, dosage, or frequency 2. Patients who are admitted into the hospital to improve their glycemic control 3. Patients who have not changed the amount, or switched to other pharmacological therapy except insulin in last 12 weeks 4. HbA1>=7% 5. Female or male patients aged 75 years or younger when giving their written consent 6. BMI>=24 7. Patients who can provide their written consent to participate in this study
Exclusion criteria
Exclusion criteria: For those who fall into any of the following criteria are excluded from the study: 1. Patients who use SGLT2, GLP-1, SU, or glinide within last 12 weeks just before giving their consent 2. Patients who are dehydrated 3. Patients who are on emulgent 4. Patients who are hospitalized as a result of sick day 5. Patients with serious infection or injury, or perioperative patients 6. Patients with a history of myocardial infarction, angina, stroke, or cerebral infarction 7. Patients with moderate renal dysfunction (eGFR<45mL/min/1.73m2) 8. Patients with severe liver functional impairment (AST>=100 IU/L) 9. Patients with moderate to severe heart failure as class 3 or worse based on the New York Heart Association (NYHA) Functional Classification 10. Patients with urinary tract infection, or genital infection 11. Patients with a malignant tumor or have a history of malignant tumor (exceptions: those are not on medication for malignant tumor, and have no recurrence of the disease so far and without recurrence risks during this study are allowed to participate) 12. If canagliflozin is prohibited to use 13. Patients with other conditions that are judged by a physician to be inappropriate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the amount of insulin dosage (unit) per day from baseline to the 2nd week | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support
Outcome results
None listed