INDIANAPOLIS (dpa-AFX) - In newly released Phase III trial data, Eli Lilly and Company's (LLY) basal insulin peglispro or BIL demonstrated statistically significantly lower hemoglobin A1c or HbA1c compared to insulin glargine at 26 and 52 weeks in people with type 1 diabetes.
BIL has a hepato-preferential activity profile derived from its reduced effect in peripheral tissue, making it more similar to endogenous insulin compared to other exogenous insulins with a conventional activity profile.
In IMAGINE-1 and IMAGINE-3, BIL demonstrated superiority in HbA1c compared to insulin glargine. Significantly more patients taking BIL met the ADA's recommended HbA1c target of less than 7 percent and experienced lower rates of nocturnal hypoglycemia compared to those taking insulin glargine.
In both trials - in which patients were taking both mealtime and basal insulin - there was a statistically significant increase in the rate of total hypoglycemia for patients taking BIL compared with those taking insulin glargine due to a higher rate of daytime hypoglycemic events.
In both trials, patients treated with BIL experienced mean weight loss compared to weight gain in patients who took insulin glargine.
In both trials, patients taking BIL had an increase in triglycerides compared to insulin glargine. In IMAGINE-3, patients taking BIL had an increase in LDL cholesterol, a decrease in HDL cholesterol and increases in systolic and diastolic blood pressure compared to insulin glargine. The rate of major adverse cardiac events MACE+ (cardiovascular death, non-fatal stroke, non-fatal MI and hospitalization due to unstable angina) was lower for patients taking BIL compared with those taking insulin glargine in IMAGINE-3. There were no MACE+ events in IMAGINE-1.
Additionally, in both studies, patients taking BIL had an increase in the liver enzyme ALT (alanine aminotransferase). Four weeks after BIL was discontinued these levels decreased toward baseline. Liver fat was measured by MRI in a subset of patients in both studies and was higher in patients treated with BIL compared to insulin glargine.
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