Introduction & Objective: SGLT2 inhibitors have been confirmed having renoprotective effects in type 2 diabetes, but their efficacy in type 1 diabetes (T1D) remains unclear. This study aimed to investigate the effects of adjunctive use of the SGLT2 inhibitor ipragliflozin (IPRA), which was approved for T1D since December 2018 in Japan, on kidney outcomes in people with T1D.
Methods: Medical records of people with T1D aged 20-74 years were retrospectively collected from 25 centers in Japan. As IPRA group, 159 cases treated with IPRA for more than 24 months from initiation (index date) were registered. As the Control (CTRL) group, 200 cases without IPRA use were registered. The kidney outcomes were compared between the two groups after randomly matching the index dates in CTRL group to those in IPRA group to exclude bias from COVID-19 pandemic period.
Results: At the index date, there were no significant differences between IPRA and CTRL groups in age (45.0 vs. 49.5 years), eGFR (81.1 vs. 81.0 mL/min/1.73 m2), and positive at microalbuminuria (29 vs. 17%), but IPRA group had significantly higher BMI, HbA1c, and insulin daily dose than Control group. In the primary endpoint, the median (range) of change in eGFR (mL/min/1.73m2) at 24 months after index date was -2.60 (-38.7 to 20.6) in IPRA group versus -2.80 (-34.0 to 22.9) in CTRL group, with no significant difference between the groups (p=0.96). In the secondary endpoints, the changes at 24 months after index date in HbA1c, body weight and insulin daily dose were significantly decreased in IPRA group than CTRL group, but those in proteinuria and were not. Incidents of severe hypoglycemia and ketoacidosis were not different between the groups.
Conclusion: This real-world study indicated that 24 months of adjunctive IPRA treatment might benefit glycemic control but did not significantly improve kidney function compared to insulin monotherapy in people with T1D.
Y. Nakamura: None. I. Horie: Research Support; Astellas Pharma Inc. N. Abiru: None. H. Yano: None. A. Kawakami: None.