Novo's Degludec Lowers Nocturnal Hypoglycemia Rates

An experimental insulin from Novo Nordisk A/S reduced the rate of dangerously low night-time blood sugar levels more than Sanofi’s Lantus, a late-stage study showed.

The product, degludec, lowered nocturnal hypoglycemia by 36 percent compared with Lantus, the world’s best-selling insulin, while obtaining equivalent improvement in blood sugar levels over a year, according to a study by Bagsvaerd, Denmark-based Novo that’s being presented today at the American Diabetes Association’s annual meeting in Philadelphia.

The results are further proof that degludec is a better product than Lantus, said Novo Chief Scientific Officer Mads Krogsgaard Thomsen. Paris-based Sanofi says Novo may have designed its trials in a way that favors degludec, an assertion the Danish company contests. The two companies are competing for market share in long-acting insulins amid a global surge in the number of diabetics.

“It’s an amazing set of data,” Thomsen said in a telephone interview. “I have not found any weak spot with degludec. There is no downside.”

Diabetes afflicts 366 million people, killing one every seven seconds, according to estimates by the International Diabetes Federation. The number of people with the disease will increase to 552 million by 2030, caused by an aging population and lifestyle changes in poorer countries, the group says.

Novo’s older product, Levemir, has been trailing Lantus, which last year generated sales of 3.92 billion euros ($4.9 billion). Levemir revenue totaled 7.68 billion kroner ($1.29 billion).

‘Unpredictable, Difficult’

Hypoglycemia can cause unconsciousness, seizures and death, according to the National Institutes of Health.

Night-time hypoglycemia “is a particular challenge for people living with diabetes, as these episodes are often unpredictable and difficult to detect,” Bernard Zinman, lead author of the study and director of the diabetes center at Mount Sinai Hospital in Toronto, said in an e-mailed statement.

Today’s results replicate the findings of two previous studies comparing degludec with insulin glargine, the chemical name for Lantus, Thomsen said. They also show that degludec leads to “significantly” lower rates of severe hypoglycemia compared to Lantus, Novo said.

Both medicines were administered once a day to 1,030 patients with Type 2 diabetes, the most common form of the disease, who hadn’t previously been treated with insulin, according to the statement.

Extended Review

The U.S. Food and Drug Administration extended the review period for degludec by three months after requesting “further data clarification and analyses,” but no additional clinical trials, Novo said yesterday, without being more specific. The FDA is now scheduled to make a decision on the treatment by Oct. 29 instead of July 29, Novo said.

We “have a very robust dataset” for degludec and “we’ve had a very constructive dialogue” with the FDA, Thomsen said.

Novo submitted degludec for approval in the U.S. and Europe in September. It’s also seeking regulatory approval in Japan, Canada, Switzerland and other countries.

Diabetes, caused by a lack of insulin needed to convert blood sugar into energy, can lead to kidney damage, blindness, heart problems and death if left untreated.

Long-acting insulins such as Lantus seek to replicate the steady stream of the hormone that healthy people produce over 24 hours. Degludec has a longer duration of action than Lantus and can be dosed in a more flexible way, according to Novo.

Sanofi’s View

Sanofi has been contesting Novo’s findings on Lantus nocturnal hypoglycemia rates, saying they were influenced by Novo’s trial design.

“Lantus’s scientific records do not support the numbers presented in a comparative way” by Novo Nordisk, Riccardo Perfetti, vice president for medical affairs at Sanofi Diabetes, said in a June 8 telephone interview. The different time of administration of the two insulins might have artificially induced hypoglycemia in Lantus users, he said.

Sanofi’s assertion of a supposedly unfair trial design is “absolutely incorrect,” Thomsen said during the interview.

Degludec is the most immediate threat for Lantus, according to Tim Anderson, an analyst with Sanford C. Bernstein in New York.

“Despite degludec being slightly better, patients and prescribers are generally happy with Lantus and most existing, well-controlled Lantus users are likely to remain on the product,” the analyst wrote in a May 29 note to investors.

“Where Lantus will begin to lose share more quickly is with ‘new patient starts,’ which will lead to market share losses gradually over time,” Anderson wrote.

Novo Nordisk plans to market degludec under the name Tresiba.

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