Lilly’s new long acting (basal) insulin, peglispro, has outperformed Sanofi’s Lantus in two clinical trials but questions remain about effects on liver and heart health.
The new insulin achieved unusually strong results in achieving significantly lower HbA1c results than the current market leading insulin Lantus (insulin glargine). In addition, Lilly’s peglispro also scored lower rates of hypoglycemia and achieved weight loss, whereas trial participants on Lantus experienced weight gain.
The trial named IMAGINE-1 was an un-blinded trial, whereby participants knew which medication they were taking and IMAGINE-3 was a blinded trial whereby the medications being taken was not known by participants. Improved HbA1c in patients taking peglispro (also known as BIL) was observed in participants with type 1 diabetes and those with type 2 diabetes.
Lilly is hoping to secure approval for the drug in the US within 18 months. However, clinical trials have shown some disadvantages which will need to considered carefully before approval is met.
Participants taking peglispro were observed to experience small increases in blood pressure and triglyceride levels, indicating possible raised risks of heart disease and microvascular complications such as retinopathy, kidney disease and neuropathy. In addition, the participants who took peglispro experienced statistically significant increases in liver fat and much higher than normal levels of the liver enzyme alanine aminotransferase (ALT).
Raised levels of ALT can indicate increased risks of liver damage and fat accumulation in the liver could potentially result in insulin resistance and liver disease after a number of years. For these reasons, the effects on the liver of the drug will need to be analysed carefully before approval is reached.
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