Basal insulin peglispro: Phase III data
Top-line data from the 78-week, open-label, international Phase III IMAGINE-1 trial in 455 Type I diabetics showed that once-daily subcutaneous basal insulin peglispro met the primary endpoint of non-inferiority to Lantus insulin glargine in reducing HbA1c from baseline to week 26. Eli Lilly also analyzed superiority for HbA1c lowering upon meeting the primary endpoint and basal insulin peglispro led to a significantly greater reduction on the endpoint vs. Lantus. Basal insulin peglispro also met the secondary endpoints of reducing the rate of nocturnal hypoglycemia and of a greater proportion of patients achieving an HbA1c of <7% vs. Lantus. The rates of total hypoglycemia and severe hypoglycemia were significantly greater in patients receiving basal insulin peglispro vs. Lantus.
Basal insulin peglispro also significantly increased triglycerides vs. Lantus. There were no significant differences between treatment groups in HDL-C or LDL-C levels. Furthermore, a significantly greater proportion of patients receiving basal insulin peglispro had an increase in alanine aminotransferase (ALT) levels to >3 times the upper limit of normal vs. Lantus. There were no cases of severe treatment-induced liver injury (Hy's law). In a subset of patients whose liver fat was measured using MRI, patients receiving basal insulin peglispro had a significant increase in liver fat vs. Lantus. All patients also received Lilly's Humalog insulin lispro. ...