Durability and Safety of Imeglimin as an Add‐On to DPP ‐4 Inhibitors in Japanese Type 2 Diabetes: The 104‐Week FAMILIAR Trial
Primary result · HbA1c change from baselineResult — go to the resultChange vs baseline −0.55 %Authors' conclusion
Imeglimin added to DPP-4 inhibitors appeared to improve glycemic control for 104 weeks, without clear attenuation. The combination was well-tolerated with a low risk of hypoglycemia even in elderly patients.
Study context
- Population
- Japanese patients with T2D with inadequate glycemic control despite DPP-4i monotherapy81 completed 104 weeks
- Participants
- 117 patients
- Comparison
- Imeglimin vs placebo added to DPP-4i, followed by imeglimin for all
- Primary endpoint
- HbA1c change from baseline
- Follow-up
- Week 104
Methodological detailsmulticenter, placebo-controlled, 24-week double-blind phase, 80-week open-label extension
- Multicenter
- Placebo-controlled
- 24-week double-blind phase
- 80-week open-label extension
Primary result
As reported in the abstract
Change vs baseline
−0.55 %
P < 0.001 vs. baseline
Change by group
Early-start
−0.55
%
Further findings
%
- HbA1c change from baseline · week 24 — Early-start
- −0.65
- HbA1c change, elderly (≥65 years) — Early-start
- −0.58
Meal tolerance tests (MTT): glucose AUC, insulin sensitivity, insulin secretion
- Early-start: sustained improvements in glucose AUC and insulin sensitivity without unnecessary insulin secretion over time
Safety
- Hypoglycemic events, elderly (≥65 years) — Early-start
- 0 events
Original publication
Durability and Safety of Imeglimin as an Add‐On to DPP ‐4 Inhibitors in Japanese Type 2 Diabetes: The 104‐Week FAMILIAR Trial. Diabetes Obes Metab. Published 19 July 2026. doi:10.
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