It's not too often we have a new insulin making its way on the scene, so we were excited to hear that Novo Nordisk filed two applications with the FDA for a new "ultra long acting" insulin called Degludec, and another for something called DegludecPlus, a combination of degludec and insulin aspart (Novolog), which would be available in an insulin pen in a fixed 70% degludec/30% Novolog ratio. The company is hoping for FDA approval as early as the end of next year.
If you thought 24 hours on Sanofi's Lantus was impressive, wait until you hear these numbers. According to Novo's Chief Medical Officer Alan Moses, degludec has an action profile that can last up to 42 hours, and possibly even longer!
"That was as long as we could do the study," Alan explains. "By 42 hours, patients were ready to get out of bed and stop the study. The longest we've gone is as long as it lasts. In some people, it clearly goes longer than that."
The biggest selling point is that a patient can take degludec at any time of the day. On Lantus and Levemir, you're pretty much stuck to the same limited window of opportunity before your basal insulin runs out and your blood sugar starts climbing. On degludec, with a longer half-life and duration of action, there is even more freedom and flexibility to adjust when the injection is taken.
"We did a study where we forced a separation of injection time," Alan explains. "Some days we had (patients) take degludec first thing in the morning. The next day, at night. The time varied between 8 and 40 hours between injections. When they did that, there was no deterioration of glucose control."
So theoretically, patients could take degludec only once every other day. But that wouldn't work for everyone, and Novo hesitated to seek FDA approval for such an unconventional treatment routine.
Alan clarified that Novo will recommend patients do take degludec at consistent times each day, to keep up consistency of their BG control. But degludec does provide more options for folks to fit their insulin therapy into their day-to-day lifestyle. For instance, changing time zones or a forgetting to take the injection because of a late-night party may no longer wreak havoc on blood sugars.
Another positive outcome found in the study was a lower rate of hypos, especially at night, and fasting blood sugars were more consistent day over day.
"I know full well the importance of maintaining constant basal rates from long-acting insulin," says Alan, whose son has type 1 diabetes. "It's important that levels are consistent from day-to-day. You should adjust your insulin to your lifestyle, rather than lifestyle to your insulin. That's an under-appreciated element unless you have diabetes."
This refers to the fact that in the clinical trials, degludec was found to have a very consistent rate of absorption, which is, as Alan notes, an under-appreciated criteria of insulin. It's easy to believe that every time you take a dose of insulin, it will work the exact same way. Thus, if you have a high or low blood sugar, then YOU must have done something wrong, right? You messed up counting carbs, underestimated your activity, etc.
But Kelly Close, industry consultant, editor of diaTribe, and PWD for 25 years, says that just isn't true and that insulin itself is part of the problem. She sees the research confirming that degludec is much more stable and predictable the previous insulins.
"My diabetes was much harder to manage years back on NPH," Kelly explains. "I didn't actually know that it was because my insulin didn't have a stable profile until I started using a much more stable rapid-acting analog. The insulins we have today are far more stable than those that were used historically, but they aren't perfect. There is still a lot of room to improve."
The degludec / Novolog combination that was filed separately (intended to be marketed as a separate product) also performed very well in clinical trials. Intended mostly for use in people with type 2 diabetes, it will allow patients to take their long-acting and rapid-acting insulin in one injection via an insulin pen. Still, the trial did include patients with type 1, and Alan says they did "remarkably well" when using the combo drug at breakfast and then Novolog injections to cover lunch and dinner.
Degludec vs. Lantus
Why this new insulin, when Novo already makes long-acting Levemir?
According to industry watchers, this is "Novo Nordisk's second attempt to topple (market-leading) Lantus after the 2004 introduction of... Levemir." Novo is coming on strong, telling the press that degludec will become the world's biggest insulin in the next 10 years. But some analysts don't see it. "The differential between degludec and Lantus is going to be minimal," says one.
A lot depends on whether or not current Lantus users will jump ship, and also how the adoption rate of degludec goes with newly diagnosed type 2s.
Typically type 2 PWDs and their doctors have been pretty hesitant about starting insulin at all. When they do decide to start, it's not a stretch to imagine they may choose degludec, but will be enough sign up for this new stuff (which is more expensive, see below) to overtake Sanofi's market leadership in basal insulin? Seems like product marketing alone wouldn't do it; there would have to be an awfully significant push to get people with type 2 diabetes on insulin sooner to begin with, as opposed to oral meds or GLP-1 options like Novo Nordisk's Victoza.
"I think that Novo Nordisk has been playing catch-up because Levemir came out later and wasn't, for many, as long-lasting as Lantus," Kelly says. "Degludec is a much improved insulin to Levemir, which was much improved to NPH but Lantus is one of the greatest diabetes products of all time. It gave patients true innovation when launched, and Sanofi has over 75% of share of the long-acting basal market today. That market should grow when degludec is introduced."
Because the FDA is so unpredictable, the timing of this insulin hitting the market could end up coinciding with the lapse of the patent on Levemir in 2014. Kelly says it's unlikely this was planned, but it could be fortuitous for Novo, if they want to push degludec as the Next Big Thing. Lucky for them, Kelly adds, "Sanofi is not planning on coming out with another insulin by 2015 that I'm aware of."
You may have read the headlines about Novo Nordisk justifying a price jump of up to 30% for this fancy new basal insulin. But is it reasonable to expect that degludec — whenever it's approved — will be more expensive?
Alan couldn't speak to specifics on price, but Kelly speculates that from a healthcare economic perspective, this might not be as bad as it sounds.
"The second a type 2 patient is taking more than one (non-generic) oral medication, their diabetes medicine likely costs more than insulin," Kelly says. "From a healthcare economics perspective, if Novo Nordisk could show it's saving money to move a patient to degludec, the payers may well cover degludec cost, even if it is slightly more expensive than Lantus and Levemir. The payers will certainly support moving people to insulin as long as the patient will take it - that's a big if, but both Sanofi and Novo Nordisk have done a lot to make insulin delivery easier - and to make it easier for doctors to teach. We know that 44% of type 2 patients are not in optimal control, which is defined as a 7% A1c by the ADA. The fact that 44% people are not in good control, and only 27% are on insulin - well, you do the math. Novo Nordisk would be smart to try to expand coverage and move more people toward better control."
We certainly hope so. With more folks being diagnosed with diabetes, and a bigger push to get folks diagnosed early, we sure as hell need better ways to keep folks healthy with affordable and easy-to-use medications. Is degludec the Holy Grail here? No way to tell until people start using it. And how soon that happens, of course, hangs on the speed and efficiency of the FDA...