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

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; SoliMix Trial Investigators

doi:10.2337/dc21-0393

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

Diabetes Care. 2021 Jun 28;44(10):2361-2370. doi: 10.2337/dc21-0393. Online ahead of print.

Affiliations

¹ Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.
² Department of Endocrinology and Metabolic Diseases, Ankara University Faculty of Medicine, Ankara, Turkey.
³ Instituto de Diabetes Obesidad y Nutrición S.C., Cuernavaca, Morelos, Mexico.
⁴ Dr. Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, IDF Centre of Excellence in Diabetes Care & ICMR Centre for Advanced Research on Diabetes, Chennai, India.
⁵ Hospital Universitario de La Ribera, Alzira, Spain.
⁶ Al Hada Military Hospital, Taif, Saudi Arabia.
⁷ Faculty of Medicine of the University of Belgrade, Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Belgrade, Serbia.
⁸ Sanofi, Buenos Aires, Argentina.
⁹ IviData LIFE SCIENCES, Levallois-Perret, France.
¹⁰ Sanofi, Paris, France.
¹¹ Diabetes Medical Operation Department, Sanofi, Chilly-Mazarin, France.

Abstract

Objective: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs).

Research design and methods: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA_1c ≥7.5% and ≤10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA_1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30.

Results: Both primary efficacy end points were met: after 26 weeks, baseline HbA_1c (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference -0.2% [97.5% CI -0.4, -0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference -1.9 kg [95% CI -2.3, -1.4]) and percentage of participants achieving HbA_1c <7% without weight gain and HbA_1c <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA_1c reduction (P < 0.001). Incidence and rates of American Diabetes Association 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. VIDEO 1: diacare;dc21-0393v4/F1F1f1Infographic available at https://care.diabetesjournals.org/content/dc21-0393-infographic.