SoliMix Study Results Unveiled: First Head-to-Head Comparison of iGlarLixi vs. Premixed Insulin in Type 2 Diabetes

SHANGHAI, July 5, 2021 /PRNewswire/ -- Marking the centenary of insulin, the 81st Scientific Sessions of the American Diabetes Association (ADA) provided the scientific community with an opportunity to review and celebrate a century of progress in diabetes treatment, and to reflect on and envision the future development of insulin. Notably, at this ADA meeting, the results of SoliMix -- the world's first head-to-head study initiated by Sanofi comparing a combination formulation of basal insulin and a glucagon-like peptide-1 receptor agonist (iGlarLixi) with premixed insulin -- were announced.

The SoliMix study enrolled patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on basal insulin plus 1–2 oral antidiabetic drugs, and assigned them to either a basal insulin/GLP-1RA fixed-ratio combination (insulin glargine/lixisenatide fixed-ratio combination, iGlarLixi) treatment group or a premixed insulin (biphasic insulin aspart 30, BIAsp 30) treatment group. Subsequently, the researchers conducted a head-to-head comparison of the two primary endpoints and multiple key secondary endpoints. In addition to being presented at the 81st ADA Scientific Sessions, the study results will also be published concurrently inDiabetes CareJournal^1,2。

SoliMixLead author of the study and Director of the Medical City Dallas Diabetes Research Center, Dallas, Texas -Julio Rosenstock Indicates:“Concerns regarding hypoglycemia and weight gain are major barriers to intensifying complex insulin regimens. The SoliMix study demonstrated that, compared with BIAsp 30, iGlarLixi therapy improves glycemic control in patients without weight gain or hypoglycemia. These multiple benefits may help clinicians consider further intensifying basal insulin therapy by switching to once-daily iGlarLixi, rather than switching to twice-daily premixed insulin therapy.”

Another analysis from the SoliMix study further demonstrated that, compared with premixed insulin, iGlarLixi achieved greater improvements in patient-reported outcomes at week 26. These patient-reported outcomes were assessed using scores from the Treatment-Related Impact Measure-Diabetes (TRIM-D) and the patient- and physician-rated Global Treatment Effectiveness Evaluation (GTEE).³, its measurement tool encompasses multiple dimensions, including treatment burden, daily living, diabetes management, adherence, mental health, and treatment efficacy.

Dr. Sandra Silvestri, Global Head of Medical, Sanofi General Medicines, stated: “Currently, approximately 40% of patients worldwide still use premixed insulin to manage T2DM. The SoliMix study provides further insights into the efficacy of iGlarLixi and patient-reported outcomes. The publication of these findings offers a new treatment option for healthcare institutions in countries and regions where premixed insulin therapy is widely utilized.”

Dr. Gu Chengming, Head of Medical Affairs for General Medicines, Greater China, Sanofi, stated: "China has approximately 129.8 million patients with diabetes⁴，ranking first globally. Meanwhile, with the overall advancement of healthcare standards in China, clinical diagnostic and treatment concepts for diabetes are also continuously evolving. Consequently, a substantial unmet need remains in the diabetes field in China. The release of the SoliMix study results also brings new hope to patients with diabetes in China. Sanofi remains steadfast in its commitment to patients in China. Moving forward, we will continue to expand our product portfolio in the diabetes sector in China, delivering more innovative treatment solutions to patients with diabetes in China.”

*iGlarLixi is an injectable antidiabetic medication composed of a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide. iGlarLixi has not yet been approved in China. iGlarLixi is known as "Suliqua" in the European Union.^®”，Suliqua^®Can be used in combination with lifestyle management and metformin, or metformin and an SGLT2 inhibitor, to improve glycemic control in adult patients with T2DM; iGlarLixi is known as "Soliqua in the United States.^®100/33", can be used in combination with lifestyle management to improve glycemic control in adult patients with T2DM; in other approved regions, iGlarLixi is also known as "Soliqua^®”。

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