Fatty Liver Index and Differential Glycemic Responses to Ipragliflozin Versus Sitagliptin Over 52 Weeks: An Exploratory Post Hoc Analysis of the Niigata Ipragliflozin and Sitagliptin With Metformin (N-ISM) Study.
Masaru Kitazawa, Takashi Katagiri, Hiromi Suzuki et al.
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In 30 seconds
This exploratory post hoc analysis of a 52-week randomised trial examined whether fatty liver index (FLI) was associated with different glycemic responses to ipragliflozin versus sitagliptin added to metformin in Japanese patients with type 2 diabetes without established ASCVD. Among 91 patients, the baseline-HbA1c-adjusted treatment-by-FLI interaction was significant (p = 0.013). In the high-FLI group, ipragliflozin was associated with a greater HbA1c reduction than sitagliptin (-0.41%, 95% confidence interval -0.77, -0.06; p = 0.023); no significant difference was found in the low-FLI group.
Key findings
- The treatment-by-FLI interaction for 52-week HbA1c change was significant (p = 0.013).
- In the high-FLI group, ipragliflozin was associated with a greater HbA1c reduction than sitagliptin (-0.41%, 95% confidence interval -0.77, -0.06; p = 0.023).
- No significant treatment difference was observed in the low-FLI group (+0.24%; p = 0.194).
- BMI and ALT also showed significant treatment interactions (p = 0.028 and 0.032), favouring ipragliflozin in their high-value subgroups.
Why it matters
The findings suggest that metabolic or liver-related measures may help identify variation in glycemic response between these two drug classes. However, FLI was not the only effect modifier, and the analysis does not establish that using FLI to select therapy improves outcomes. It highlights a potential source of treatment-response heterogeneity for prospective evaluation.
What to keep in mind
The analysis was post hoc and based on a small, complete-case sample; its FLI cut-off was derived from the sample.