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
Authors' conclusion
FLI-based stratification was associated with differential glycemic responses to ipragliflozin versus sitagliptin.
Study context
- Population
- Japanese patients with T2D without established atherosclerotic cardiovascular disease, second-line therapy added to metformin
- Participants
- 91 patients
- Comparison
- Ipragliflozin vs sitagliptin added to metformin, by fatty liver index (FLI) stratum
- Low FLIn = 44
- High FLIn = 47
- Primary endpoint
- Change in haemoglobin A1c (HbA1c)
- Follow-up
- 52 weeks
Methodological detailsexploratory post hoc analysis, 52-week, stratified by median FLI
- Exploratory post hoc analysis
- 52-week
- Stratified by median FLI
Primary result
As reported in the abstract
52-week change in HbA1c, by FLI subgroup
Ipragliflozin vs SitagliptinDifference, % (95% CI)P value
High FLI
−0.41(−0.77 to −0.06)
P = 0.023- Low FLI; no significant difference
- difference +0.24 %; P = 0.194
- Baseline-HbA1c-adjusted treatment-by-FLI interaction
- P = 0.013
Further findings
Treatment-by-FLI interaction, FLI modelled continuously · 52 weeks
- Interaction significant with FLI continuous
- P = 0.013
Sensitivity analyses of treatment-by-FLI interaction · 52 weeks
- Mixed-model sensitivity analysis
- P = 0.010
- Multiple-imputation sensitivity analysis
- 0.003
Treatment-by-BMI and treatment-by-ALT interactions · 52 weeks
- Body mass index (BMI) interaction, favouring ipragliflozin in high-value subgroup
- P = 0.028
- ALT interaction, favouring ipragliflozin in high-value subgroup
- 0.032
- FLI provided the clearest signal but was not the only effect modifier
Original publication
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. Diabetes Obes Metab. Published 17 August 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →