Type 2 diabetes
Conditions
Interventions
DPP-4 inhibitor (Administered according to the package insert)
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast (Without DPP-4 inhibitor)
Orally administration of 50 mg i
Sponsors
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provide written informed consent 2) Aged from 20 to 80 years at providing consent 3) At least 12 weeks after being diagnosed as type 2 diabetes at initiation 4) Patients who undergoes only diet/exercise therapy, or poorly glycemic controlled nevertheless who undergo hypoglycemic agent except for SGLT-2 inhibitor at least 12 weeks 5) HbA1c >=7.0% and <10.0% [Inclusion criteria for DPP-4 inhibitor group] 6) Has less than 6 months medical history of DPP-4 inhibitor without any change in prescription at enrollment, and meet 1)-5) of inclusion criteria [Inclusion criteria for ipragliflozin group] 7) Not administered DPP-4 inhibitors at enrollment, and meet 1)-5) of inclusion criteria [Inclusion criteria for ipragliflozin and DPP-4 inhibitor concomitant in poorly glycemic controlled group] 8) Has at least 6 months medical history of DPP-4 inhibitor from enrollment, and meet 1)-5) of inclusion criteria
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) Has history of hypersensitivity to study drugs 5) Renal dysfunction (Serum Creatinine male: >= 1.5 mg/dL, female: >= 1.3 mg/dL, eGFR < 30 ml/min/1.73m2) 6) With serious hepatic dysfunction 7) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months at initiation 8) Is receiving SGLT-2 inhibitor, insulin, or GLP-1 agonist at initiation 9) Is pregnant, nursing, or planned to become pregnant 10) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Until changing of currently administered medication or addition of other medications at registration Change and percent change in following items from baseline to 12, 24, 36 and 52 weeks 1) HbA1c (Except for 52 week) 2) Body weight 3) Waist circumference 4) Plasma glucose (Fasting or casual) 5) IRI (HOMA-IR, HOMA-beta) 6) Serum lipids: TC, TG, HDL-C, (LDL-C, non HDL-C) (LDL-C is calculated by Friedewald equation, and if TG level is more than 400 mg/dL, it is treated as a reference value 7) Blood pressure (If measured at home, either those at home or those at examination room, whichever lower is adopted) 8) Leptin, adiponectin, glucagon, GIP, GLP-1 (Glucagon measurement is done at fasting. If the case of postprandial, time from last meal is recorded) 9) Serum ketone bodies (Specific examination will be performed, if possible ) 10) Analyzed stratified by patient characteristics such as duration of diabetes and concomitant drug | — |
Countries
Japan
Contacts
Public ContactFumio Sawano
Sawano Thyroid and Diabetes Specialized Clinic President
Outcome results
None listed