Soliqua 100/33

Soliqua 100/33 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on a basal insulin (less than 60 units daily) or on lixisenatide. The drug is supplied as a single pen and single product strength, containing 100 units of glargine and 50 mcg of lixisenatide per mL. The maximum insulin glargine dose in Soliqua is 60 units, and the lixisenatide dose ranges from 5-20 mcg.

In clinical trials, Soliqua 100/33 demonstrated a greater extent of HbA1c reduction. The LS mean change in HbA1c from baseline was -1.63% for Soliqua 100/33 compared to -0.85% for insulin glargine, with an LS mean treatment difference of -0.78% (p-value < 0.0001). Additionally, 74% of patients on Soliqua 100/33 achieved an HbA1c below 7%. Body weight change from baseline varied, with a reported change of -2.3 kg. The trial design was randomized, open-label, multi-center, multi-national, with 3 arms, parallel-group, and active controlled, involving 469 participants over 30 weeks.

Safety findings included serious adverse reactions in 4.7% of patients and discontinuation due to adverse reactions in 2.8%. Hypoglycemia (< 70 mg/dL with symptoms) was reported in 27% of patients. There were 3 reported deaths. Allergic reaction events related to the investigational product were 0%.