Type 1 diabetes
Conditions
Interventions
Administered once a day Ipragliflozin 50mg after breakfast for three months or more
Sponsors
Minami Osaka Hospital Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Applicable age 20 years old and under 75 years old 2.Patients diagnosed with type 1 diabetes for more than 1 year from the start of the study 3.Patients who underwent multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) 12 weeks before the start of the study 4.Patients with glycated hemoglobin (HbA1c) levels 7.0% or more and less than 10.5% 5.patient with body mass index (BMI) 20kg/m2 or more and 45.0kg/m2 or less
Exclusion criteria
Exclusion criteria: 1.The patient with severe ketosis, diabetic comA or previous coma within six weeks before examination start 2.The patient who developed severe hypoglycemia (a diabetic coma or a previous coma and convulsionsneed the assistance of the third person) within six weeks before examination start 3.The patient with medically important renal disease such as a history of renal vascular occlusive disease, nephrectomy, kidney transplantations, etc 4.The patient with dysuria, anuria, oliguria or the symptom of the anuria 5.The patient whom urinary tract infection having subjective symptoms, a sexual organs infectious disease developed in within six weeks before examination start 6.The patient with a severe renal function disorder (eGFR <30mL/min/1.73m2 or serum creatinine level >= 2.0mg/dL) or the end-stage renal disease on dialysis 7.The patient with a proliferative retinopathy (however, patients symptoms are stable by implementing the photocoagulation, etc., can incorporate) 8.The patient complicated with serious digestive tract disturbance within two weeks before examination start or the patient who has an operation career of serious digestive tract disturbance 9.The patient with pregnancy or may be pregnant and the patient in nursing 10.The patient with severe infectious disease, serious injury and before and after operation 11.The patient who receives systemic administration of corticosteroids drugs 12.The patient with a serious liver function disorder more than 100 U/l of AST or ALT 13.The patient with a history of allergy to Ipragliflozin 14.The patient with the past of a malignant tumor or the malignant tumor at the moment 15.In addition, patients who test the attending physician has determined to be inappropriate as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c levels | — |
Secondary
| Measure | Time frame |
|---|---|
| For 3 days of FGM, percentage of time of blood glucose level of less than 70mg/dl (hypoglycemia range) , percentage of time of blood glucose level of 180mg/dl or more (hyperglycemia range), percentage of time of blood glucose level 70-179mg/dl (normoglycemia range), percentage of time of blood glucose level less than 54mg/dl (severely hypoglycemic range), percentage of time of nocturnal hypoglycemia (0:00-5:59, less than 70 mg/dl), frequency of severe hypoglycemia (the extent of occurrence of coma, premature coma, convulsions need of third-person assistance, SD value, CV value, day difference variation, M value, MAGE, change in BMI, the change of insulin dose. | — |
Countries
Japan
Contacts
Public ContactYuji Kawaguchi
Minami Osaka Hospital Internal Medicine
Outcome results
None listed