Study on the efficacy of ipragliflozin for prevention of chronic kidney disease in type 1 diabetes

Not Applicable

Recruiting

• Conditions: Type 1 diabetes

• Registration Number: JPRN-jRCT1071220115
• Lead Sponsor: Horie Ichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 360

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified