American Diabetes Association
Online-Only_Supplementary_Material_Second_peer_review_04Jun21.pdf (334.69 kB)

Advancing Therapy in Suboptimally Controlled Basal Insulin-Treated Type 2 Diabetes: Clinical Outcomes with iGlarLixi versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial

Download (334.69 kB)
Version 2 2021-08-12, 19:12
Version 1 2021-06-24, 21:41
posted on 2021-06-28, 00:33 authored by Julio Rosenstock, Rifat Emral, Leobardo Sauque-Reyna, Viswanathan Mohan, Carlos Trescolí, Saud Al Sifri, Nebojsa Lalic, Agustina Alvarez, Pascaline Picard, Mireille Bonnemaire, Nacima Demil, Rory J. McCrimmon, the SoliMix Trial Investigators

Objective: To directly compare the efficacy and safety of a fixed-ratio combination, iGlarLixi, with a premix insulin analog (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs).

Research Design and Methods: SoliMix, a 26-week, open-label, multicenter study, randomized adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA1c ≥7.5 % and ≤10 %) to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA1c reduction (margin 0.3 %) or superiority in bodyweight change for iGlarLixi versus BIAsp 30.

Results: Both primary efficacy endpoints were met: after 26 weeks, baseline HbA1c (8.6 %) was reduced by 1.3 % with iGlarLixi and 1.1 % with BIAsp 30, meeting non-inferiority (least squares [LS] mean difference [97.5% CI]: -0.2 [-0.4, -0.1] %; p<0.001). iGlarLixi was also superior to BIAsp 30 for bodyweight change (LS mean difference [95% CI] -1.9 [-2.3, -1.4] kg) and percentage of participants achieving HbA1c <7 % without weight gain and HbA1c <7 % without weight gain and without hypoglycemia (all p<0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (p<0.001). Incidence and rates of ADA Level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30.

Conclusions: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy.


Sponsorship for this study was funded by Sanofi, Paris, France. Editorial assistance provided by Fishawack Communications Ltd. was funded by Sanofi.