Type 1 diabetes
Conditions
Interventions
None listed
Sponsors
Nagasaki University
Hokkaido University Hyogo College of Medicine Showa University School of Medicine Kobe University Graduate School of Medicine Minami Diabetes Clinical Research Center Kumamoto Central Hospital Sasebo City General Hospital Sasebo Chuo Hospital National Hospital Organization Nagasaki Medical Center Midori Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be recruited to meet all of the following criteria: 1) Diagnosed type 1 diabetes by diabetologists and had more than 5 years history of type 1 diabetes 2) A)Ipragliflozin group (n=120): Patients who administered ipragliflozin more than 24 months before enrollment. B) Control group (n=240): Patients who have not administered any SGLT2 inhibitors more than 60 months before enrollment. 3) Age of between 20 and 75 years. 4) Any sexes 5) Outpatients 6) Willingness to provide informed consent
Exclusion criteria
Exclusion criteria: Patients with any of the following will be excluded: 1)Patients administered any SGLT2 inhibitors except for ipragliflozin during 24 months after index date. 2)Patients who administered ipragliflozin inadequately. 3) Patients who had previous history of malignancy within 5 years before enrollment or 2 years before/after index date. 4) Alcohol abuse or alcohol consumption > 20g per day 5) Patients who underwent hemodialysis within 5 years before enrollment or 2 years before/after index date. 6) Patients who had a history of pregnancy and/or breastfeeding within 5 years before enrollment or 2 years before/after index date. 7) Willingness not to provide informed consent. 8) Judged inappropriate to participate by the study investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be determined by the annual rate of change in eGFR (mL/min/1.73 m2) from the initiation of ipragliflozin in the ipragliflozin group compared to those during 24 months equivalent to the period in the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be determined by the composite end point of a sustained reduction in eGFR of > 50 %, or severe impairment of kidney function which was defined as an eGFR <30 mL/min/1.73 m2 (i.e. CKD stage G4 and G5), or doubling time of urinary albumin (protein) per creatine. | — |
Countries
Japan
Contacts
Public ContactIchiro Horie
Nagasaki University Hospital Endocrinology and Metabolism
Outcome results
None listed