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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

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posted on 28.06.2021, 00:33 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.


Funding

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

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