Sanofi diabetes drug shows successful results: study

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About 9.3 percent of the American population had diabetes in 2012, according to the American Diabetes Association, which means 29.1 million Americans are afflicted with this disease. Additionally, 90 percent of diabetes cases worldwide are of the type 2 variety.

Good news has come to light recently, however, as Sanofi's LixiLan diabetes drug has succeeded in achieving its goals during a second late-stage Phase III study, and is therefore ready for regulatory submission later this year, according to Reuters.

The drug, which is a single-injection combination of Sanofi's Latus and Danish drug manufacturer Zealand Pharma's Lyxumia, is targeted to patients with type 2 diabetes. According to CNN Money, Lantus is the world-wide most prescribed basal insulin, while Lyxumia (Lixisenatide) is a prandial GLP-1 receptor agonist.

CNN Money further reports that in the clinical trial, LixiLan was successful in meeting the primary study endpoint of demonstrating a statistically superior decrease in HbA1c, which is the average blood glucose over the previous 3 months, versus insulin glargine 100 units/mL. Results showed that LixiLan had a safety profile such as those of insulin glargine 100 units/mL and lixisenatide.

According to CNN Money, LixiLan was tested on 1/170 patients whose type 2 diabetes was not adequately controlled on metformin or metformin combined with another oral anti-diabetic agent. Results showed that in the course of 30 weeks, there was a significant reduction of HbA1c.

Zealand released a statement saying, "The LixiLan-L Phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin. The fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 Units/mL."

Zealand added that "Full results will be communicated in a future scientific forum."

CNN Money reports that Britt Meelby Jensen, President and CEO of Zealand said, "With positive results now demonstrated in two pivotal Phase III trials, the planned regulatory submissions of LixiLan by Sanofi before year-end in the US and next year in Europe remain on track. It is our belief that the LixiLan fixed-ratio combination of our invented medicine, lixisenatide, with insulin glargine has the potential to offer patients with Type 2 diabetes a new valuable type of treatment - for use both after failure of oral medication, and when basal insulin alone does not provide sufficient blood sugar control."

Jensen also said, "The revenue prospects from LixiLan are important for Zealand to help support the advance and accelerated value creation of our proprietary pipeline."