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 [post]

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 (+1 others)
2021 unpublished
<p><b>Objective: </b>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).</p> <p><b>Research Design and Methods: </b>SoliMix, a 26-week, open-label, multicenter study, randomized adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA<sub>1c</sub> ≥7.5 % and ≤10 %) to
more » ... y iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA<sub>1c</sub> reduction (margin 0.3 %) or superiority in bodyweight change for iGlarLixi versus BIAsp 30.</p> <p><b>Results: </b>Both primary efficacy endpoints were met: after 26 weeks, baseline HbA<sub>1c</sub> (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 HbA<sub>1c</sub> <7 % without weight gain and HbA<sub>1c</sub> <7 % without weight gain and without hypoglycemia (all p<0.001). iGlarLixi was also superior versus BIAsp 30 for HbA<sub>1c</sub> reduction (p<0.001). Incidence and rates of ADA Level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30.</p> <p><b>Conclusions: </b>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.</p> <b><br> </b> <p> </p>
doi:10.2337/figshare.14754426.v1 fatcat:5s6fcwqv65aatiry2rbs37je5i