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news.Eli Lilly has presented positive data from the Phase III clinical trial program of its basal insulin peglispro (BIL) in reducing HbA1c in people with type 2 diabetes.
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The company said that the trials compared BIL and insulin glargine in three common type 2 patients including those not previously using insulin (IMAGINE-2), those using basal insulin with mealtime insulin (IMAGINE-4) and those currently using a basal insulin (IMAGINE-5).
The IMAGINE-2 is a phase III, randomized, 52-week, double-blind, treat-to-target study of BIL in insulin-naïve patients with type 2 diabetes while IMAGINE-4 is a phase III, randomized, 26-week, double-blind, treat-to-target study aimed to compare BIL to insulin glargine in combination with mealtime insulin in patients with type 2 diabetes.
The IMAGINE-5 is a phase III, 52-week, open-label, randomized, treat-to-target study intended to evaluate BIL in patients with type 2 diabetes already taking a basal insulin whereas IMAGINE-6 is a phase III, 26-week, open-label, treat-to-target, randomized study designed to determine if BIL was non-inferior to NPH insulin in reducing HbA1c when added to pre-study oral agents.
Currently in phase III clinical trials, the BIL is being studied as a once-daily basal insulin treatment for type 1 and type 2 diabetes.
Lilly Diabetes medical affairs vice-president David Kendall said: "BIL is mechanistically different from current basal insulins. It has a hepato-preferential action, driven by its reduced effect on peripheral tissues.
"What we’ve seen from the Phase III trials are unprecedented results in the basal insulin space: superior glycemic control with less nocturnal hypoglycemia and reduced weight gain, all of which are important to physicians and patients."
As part of the clinical trial program, approximately 3,900 of more than 6,000 patients have been treated with BIL to date.
Comprising seven IMAGINE trials in patients with type 1 and type 2 diabetes, the Phase III core clinical trial program completed five trials against insulin glargine and revealed superior HbA1c.
The company said that BIL has consistently reduced HbA1c levels in all three type 2 diabetes trials from baseline to the primary endpoint compared to insulin glargine.
According to the data from IMAGINE-2, IMAGINE-4 and IMAGINE-5, BIL-treated patients met the ADA’s recommended HbA1c target of less than 7% and have nocturnal hypoglycemia compared to those on insulin glargine.