Differences in imeglimin response in subgroups of patients with type 2 diabetes stratified by data‐driven cluster analysis: A post‐hoc analysis of imeglimin clinical trial data
Authors' conclusion
Differences in imeglimin response were observed among T2D patient clusters. Patient stratification may help with selection of those most probable to respond to imeglimin.
Study context
- Population
- Patients with T2D in imeglimin monotherapy and adjunctive (to insulin) trials, clustered by disease duration, body mass index (BMI), HbA1c and HOMA-β (monotherapy) or insulin total daily dose (adjunctive)
- Comparison
- Imeglimin vs placebo across data-driven T2D clusters
- Primary endpoint
- Between-group difference in HbA1c change by cluster
- Follow-up
- Week 24 (monotherapy); week 16 (adjunctive)
Methodological detailsrandomized, double-blind, non-hierarchical k-means clustering, monotherapy and adjunctive (to insulin) therapy trials
- Randomized
- Double-blind
- Non-hierarchical k-means clustering
- Monotherapy and adjunctive (to insulin) therapy trials
Primary result
As reported in the abstract
Between-group difference in HbA1c change by cluster (monotherapy trials, clusters 1–4, week 24; adjunctive-to-insulin trial, clusters I–IV, week 16)
Between-group difference in HbA1c change (95% CI)
Cluster 1monotherapy, week 24; ES = 1.47
−0.82(−1.00 to −0.63)
Cluster 2monotherapy, week 24; ES = 1.18
−0.64(−0.89 to −0.39)
Cluster 3monotherapy, week 24; ES = 0.84
−0.86(−1.38 to −0.33)
Cluster 4monotherapy, week 24; ES = 1.44
−1.27(−1.73 to −0.82)
- Cluster I · adjunctive therapy, week 16; Effect size (ES) = 0.88
- HbA1c improvement vs placebo −0.63 (95% CI −0.95 to −0.31)
- Cluster II · adjunctive therapy, week 16; ES = 1.13
- HbA1c improvement vs placebo −0.66 (95% CI −1.02 to −0.30)
- Cluster III · adjunctive therapy, week 16; ES = 0.46; not significant
- HbA1c improvement vs placebo −0.31 (95% CI −0.73 to 0.11)
- Cluster IV · adjunctive therapy, week 16; ES = 0.99
- HbA1c improvement vs placebo −0.82 (95% CI −1.29 to −0.35)
Further findings
| Outcome | Estimate | |
|---|---|---|
| HbA1c change, adjunctive therapy trial, by cluster · week 16Imegliminvs PlaceboES = 0.88 | difference, cluster I −0.63 (95% CI −0.95 to −0.31) | |
| HbA1c change, adjunctive therapy trial, by cluster · week 16Imegliminvs PlaceboES = 1.13 | difference, cluster II −0.66 (95% CI −1.02 to −0.30) | |
| HbA1c change, adjunctive therapy trial, by cluster · week 16Imegliminvs PlaceboES = 0.46; not significant | difference, cluster III −0.31 (95% CI −0.73 to 0.11) | |
| HbA1c change, adjunctive therapy trial, by cluster · week 16Imegliminvs PlaceboES = 0.99 | difference, cluster IV −0.82 (95% CI −1.29 to −0.35) | |
| −2−101Difference (linear scale) |
HbA1c change, adjunctive therapy trial, by cluster · week 16
- HbA1c improvements significant vs placebo, excluding cluster III
Original publication
Differences in imeglimin response in subgroups of patients with type 2 diabetes stratified by data‐driven cluster analysis: A post‐hoc analysis of imeglimin clinical trial data. Diabetes Obes Metab. Published 25 June 2024. doi:10.
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