Sanofi gets a nod from FDA

This is an interesting take on the future for Type 2’s. Sanofi diabetes treatment application gets FDA nod - MarketWatch

Keep in mind that this is a “New Drug Application” meaning that they have applied, not that it has been approved. I also have to call into question the whole idea. Seriously? A fixed dose of basal insulin. How many patients need exactly 20 units of basal insulin. If 20 units is too much then it doesn’t work. And if 20 units isn’t enough then you have to take this combination basal/GLP-1 and still take more basal. If so, then what is the point, you still have two prescriptions and two injections. I predict a flop.

Sounds like a desperation move to drag out some more patent protection for glargine perhaps?

I think we might be surprised how many type 2 diabetics just get put on a nice round number like 20 units of glargine, or 40, or 60 and rarely revisit the issue with their doctors—

Well, that reflects the culture at large. Many docs apply a one-size-fits-all rule to patients who in turn never think to even question anythng but just go blithely on their way taking all medical advice as unquestioned holy writ.

In defence of doctors, many older Type 2s do not understand that you have to balance insulin and food and can get themselves into serious trouble through over or underdosing. I’ve seen this happen, sadly.

Of course, but a fixed, unvaryingdose doesn’t solve that problem. It even has the potential to make it worse. Any way you slice and dice it, lack of education renders any strategy unreliable.

I use 20 units of glargine each night or later in the early hours of the morning (when I don’t remember). I will say that I like it, but I am going to split the dose into 10 around midnight and 10 for lunch.

This idea came from me sliding smoothly past breakfast and lunch. And then struggling for hours to get control of things after dinner. I think the long-acting glargine loses effectiveness after 18 hours.

Me too Me too

http://www.fiercepharmamarketing.com/story/another-reason-tresiba-uptake-crucial-novo-xultophys-blockbuster-hopes/2015-09-30

I guess Basal + GLp 1 is the new fade

Not every patient is willing to do much more than this… I’m sure doctors would love it if all their patients were as interested and capable of micromanaging diabetes as successfully as many of us here on this forum do— I think that in the real world often times they consider it a victory to just get non compliant patients to take their meds at all, even when their regimen is made as simple and non burdensome as possible, let alone test their blood sugar regularly and keep logs, etc that assist in treatment decisions.

Also would add that in my opinion the most effective insulin ever developed, afrezza, essentially is used as very- near a fixed dose— of course that’s a different animal than glargine though.

I agree @Sam19 – the majority of patients want it simple, if at all. Not the best, in all likelihood, but better than nothing at all, most likely. Ironically, I think a lot (most?) doctors also don’t quite get it - and want it as simple as possible, too. My ex-endo – despite seemingly being quite educated in diabetes management, once suggested to me that while (in his opinion), I would get no benefit from switching to a standard insulin pump, it might be worthwhile for me to look into something like the V-Go pump. Totally shocked me that he would say something like that! How would a fixed-basal pump help me get better control when I couldn’t do so on standard MDI – and why wouldn’t a standard pump help??

I switched endos, the new endo immediately suggested that a pump would get me the best chance as the control I wanted (though he was, rightfully, concerned about cost and approval problems). And yes, the pump has helped in many ways.

Point is: lots of doctors, as well as patients, prefer simple and unchanging to much more variable management - even if the latter is more precise.

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Brian, my interpretation of the news is that lixisenatide itself is fixed in ratio (between insulin analog and incretin mimetic) but that only the current study is designed for a fixed dose. They might select the cohort for compatibility. Sanofi might even know that only T2Ds within a certain range of endogenous insulin production capability respond well to the combination – hence, the study design.
I did not review the design of the study itself. But the product itself is an injectable and seems compatible with all such means of application. Benefits would seem achievable from separate prescriptions and separate injections of the two constituent products, by the way. This might still be the more cost-effective way to go after approval (if this happens), for those interested.

Since I’d never, ever heard of this thingee, I googled.

I tried browsing the FAQ on the companies web site, www.go-vgo.com/, but I couldn’t find the “What The Cluck Is This Thing Anyway?” question. Well, I suppose that’s to be expected. :blush:

A wider search turned up this ~4 year old perspective piece on DiabetesMine:
V-Go: Dissecting a New Breed of Patch Pump for Type 2s

… Valeritas’ entry into the pump market is something entirely different [from the OmniPod]. For one thing, it doesn’t use electricity. For another thing, it isn’t programmable. And it doesn’t even use infusion sets or cannulas.

Apparently it is powered by a big honkin’ spring. Weird … at least to me. :slightly_smiling: I guess whatever makes your socks go up & down.

Not mine! I see no advantage to me to use something with no variability. The variable basal rate is the most important pump feature for me. I’m sure the V-Go is great for someone who forgets to take their basal and might also forget to carry bolus insulin with them - this would assist with both of those conditions.

Just sow how little my ex-endo knew about me and my needs.

I notice Sanofi loses no opportunity to trash Afrezza, the insulin they helped scuttle, in any press release. This was an application for a new drug. No need for them to mention the inhalable insulin… Given that Afrezza was rolled out to ONE endo in the whole New York metro area, they didn’t fight for Tier 2 coverage, they didn’t market it… Sanofi, at this point, stop mentioning Afrezza in an attempt to give it bad press. You may have been successful at accomplishing your aim. No need to twist the knife.

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Part of the reason that I don’t use sanofi products, the other reason is that they’re generally inferior.

That’s a bit of a blanket statement. While I agree with you that they apparently did not handle Afrezza equitably, I know that a lot of people (myself, included) find Apidra to be a useful product, and many prefer Lantus over Levemir (Tresiba may well be better, but it still is the new player.)

I suppose that if I got the same results from Novolog that I do from Apidra, I’d switch, but that isn’t the case - not for me, not for many. We’ll see what comes down the road, but as it is, I’ll still use at least one Sanofi product.

I don’t think anyone would argue that Apidra isn’t a good insulin. They introduced it in 2004. Since then all they’ve done is sabotage a vastly superior rapid acting insulin that they were contracted to market and add a little bit less water to lantus and relabel it as toujeo. Bravo sanofi. I’m voting with my feet.