Diabetes, obesity & metabolism · 2025
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.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Kaku Kohei, Shimoda Masashi, Osonoi Takeshi, Iwamoto Masahiro, Kaneto Hideaki
Аннотация
AIMS: The ongoing FAMILIAR trial aims to provide evidence for clinical decision-making and offer a novel treatment paradigm in type 2 diabetes mellitus (T2DM) management. The interim findings of FAMILIAR through Week 24 are reported.
MATERIALS AND METHODS: FAMILIAR is a multicentre, randomised, double-blind study comparing the efficacy and safety of imeglimin versus placebo in adult Japanese patients with T2DM and inadequate glycaemic control despite dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy, plus diet/exercise modifications. Patients entered a 24-week double-blind treatment phase (oral imeglimin 1000 mg or placebo twice daily) followed by an 80-week open-label phase (oral imeglimin 1000 mg twice daily). The primary end-point was change in glycated haemoglobin (HbA1c) level from baseline at Week 24. Safety was also monitored.
RESULTS: Overall, 117 patients were randomised (imeglimin, n = 58; placebo, n = 54; excluded, n = 5). The least squares mean (standard error) changes in HbA1c level (baseline to Week 24) for the imeglimin and placebo groups, respectively, were -0.65% (0.11%) and 0.38% (0.11%) in the overall population (group-difference -1.02% [95% confidence interval -1.33%, -0.72%]; p < 0.001); -0.47% (0.17%) and 0.32% (0.18%) in patients aged <65 years (-0.79% [-1.29%, -0.29%]; p = 0.003); and -0.80% (0.14%) and 0.42% (0.14%) in patients aged ≥65 years (-1.22% [-1.61%, -0.82%]; p < 0.001). One patient in the imeglimin group had mild hypoglycaemia; the safety profile was favourable.
CONCLUSIONS: Imeglimin represents a potential new treatment option for patients with T2DM and inadequate glycaemic control with DPP-4 inhibitors, including those aged ≥65 years.
CLINICAL TRIAL REGISTRATION: jRCTs061210082.
MATERIALS AND METHODS: FAMILIAR is a multicentre, randomised, double-blind study comparing the efficacy and safety of imeglimin versus placebo in adult Japanese patients with T2DM and inadequate glycaemic control despite dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy, plus diet/exercise modifications. Patients entered a 24-week double-blind treatment phase (oral imeglimin 1000 mg or placebo twice daily) followed by an 80-week open-label phase (oral imeglimin 1000 mg twice daily). The primary end-point was change in glycated haemoglobin (HbA1c) level from baseline at Week 24. Safety was also monitored.
RESULTS: Overall, 117 patients were randomised (imeglimin, n = 58; placebo, n = 54; excluded, n = 5). The least squares mean (standard error) changes in HbA1c level (baseline to Week 24) for the imeglimin and placebo groups, respectively, were -0.65% (0.11%) and 0.38% (0.11%) in the overall population (group-difference -1.02% [95% confidence interval -1.33%, -0.72%]; p < 0.001); -0.47% (0.17%) and 0.32% (0.18%) in patients aged <65 years (-0.79% [-1.29%, -0.29%]; p = 0.003); and -0.80% (0.14%) and 0.42% (0.14%) in patients aged ≥65 years (-1.22% [-1.61%, -0.82%]; p < 0.001). One patient in the imeglimin group had mild hypoglycaemia; the safety profile was favourable.
CONCLUSIONS: Imeglimin represents a potential new treatment option for patients with T2DM and inadequate glycaemic control with DPP-4 inhibitors, including those aged ≥65 years.
CLINICAL TRIAL REGISTRATION: jRCTs061210082.