Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.
Interventions
DRUGIpragliflozin (SGLT2 inhibitor)
Sponsors
Osaka Saiseikai Nakatsu Hospital
Astellas Pharma Inc
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs 2. Patients with changes within +- 0.5% of HbA1c 3. Patients with the variation of 6.5% =\< HbA1C =\<10% 4. Patients with written informed consents 5. Patients whose BMI is =\>20kg/m2
Exclusion criteria
1. Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes 2. Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months 3. Patients with severe infection, in the perioperative period or severe trauma 4. Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL、female with greater than or equal to1.3mg/dL) 5. Patients with severe hepatic impairment (judged by the attending doctor) 6. Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent 7. Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy 8. Patients with neuropathic bladder or dysuria 9. Patients under treatment with diuretic 10. Patients under SGLT2 treatment at the kickoff point of the study 11. Patients with a history of hypersensitivity to SGLT2 inhibitors 12. Patients who are judged ineligible by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change level | After 52 weeks from the time of treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sugar metabolism and body composition change levels | After 12, 24, 36, 52 weeks from the time of the start of treatment | Change levels of the followings after 12, 24, 36, 52 weeks from the time of treatment initiation: HbA1c, blood glucose (both at fasting and after eating), glycoalbumin, body weight, BMI, serum lipid (TC、LDL-C、HDL-C、TG), blood pressure (both systolic and diastolic) |
| HbA1c achievement rate | After 12, 24, 36, 52 weeks from the time of treatment initiation | The rate of less than HbA1c7.0% achievement after 12, 24, 36, 52 weeks from the time of treatment initiation |
| Body composition and visceral fat change levels | After 24 and 52 weeks from the time of treatment initiation | Changes of the body composition examined by DEXA (Dual-energy X-ray absorptiometry) method and visceral fat examined by CT scan after 24 and 52 weeks from the time of treatment initiation |
Countries
Japan
Outcome results
None listed