Efficacy and safety of imeglimin add‐on to DPP ‐4 inhibitor therapy in Japanese patients with type 2 diabetes mellitus: An interim analysis of the randomised, double‐blind FAMILIAR trial
Primary result · Change in HbA1c from baseline (overall population)Result — go to the resultGroup-difference −1.02 % 95% CI −1.33% to −0.72%Authors' conclusion
Imeglimin represents a potential new treatment option for patients with T2DM and inadequate glycaemic control with DPP-4 inhibitors, including those aged ≥65 years.
Study context
- Population
- Adult Japanese patients with T2D and inadequate glycaemic control despite DPP-4i monotherapy plus diet/exercise modificationsrandomised
- Participants
- 117 patients
- Comparison
- Imeglimin vs placebo added to DPP-4i monotherapy
- Imegliminn = 58
- Placebon = 54reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, placebo-controlled, prespecified interim analysis, 24-week double-blind phase followed by 80-week open-label imeglimin phase (ongoing)
- Multicentre
- Double-blind
- Placebo-controlled
- Prespecified interim analysis
- 24-week double-blind phase followed by 80-week open-label imeglimin phase (ongoing)
Primary result
As reported in the abstract
Change in HbA1c from baseline (overall population)
Group-difference
−1.02 %
95% CI −1.33% to −0.72%
P < 0.001
Change by group
Imeglimin
−0.65
least squares mean · SE 0.11% · %
Placebo
0.38
least squares mean · SE 0.11% · %
Imegliminvs Placebo
group-difference −1.02 % (95% CI −1.33% to −0.72%); P < 0.001
Further findings
Least squares mean, %
| Outcome | Imeglimin | Placebo | Group-difference (%) (95% CI) | P value | |
|---|---|---|---|---|---|
| Change in HbA1c, patients aged <65 years · Week 24Interim analysis | −0.47 (SE 0.17%) | 0.32 (SE 0.18%) | −0.79 (−1.29% to −0.29%) | P = 0.003 | |
| Change in HbA1c, patients aged ≥65 years · Week 24Interim analysis | −0.80 (SE 0.14%) | 0.42 (SE 0.14%) | −1.22 (−1.61% to −0.82%) | P < 0.001 | |
| −2−101Difference, % (linear scale) |
Safety
- Hypoglycaemia and safety profile — Imeglimin
- 1 events
Hypoglycaemia and safety profile
- Mild hypoglycaemia in 1 imeglimin patient; safety profile favourable
Original publication
Efficacy and safety of imeglimin add‐on to DPP ‐4 inhibitor therapy in Japanese patients with type 2 diabetes mellitus: An interim analysis of the randomised, double‐blind FAMILIAR trial. Diabetes Obes Metab. Published 21 March 2025. doi:10.
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