# First oral drug for type 1 diabetes set to be offered on the NHS as additional therapy to insulin



## Northerner (Jul 12, 2019)

Following approval for use across Europe, the type 2 diabetes drug dapagliflozin has today been recommended for use on the NHS in certain groups of people with type 1 diabetes.

The first of its kind in type 1 diabetes treatments, dapagliflozin is a one-a-day pill which, when used alongside standard insulin therapy, could significantly improve long-term health outcomes for many people with the condition. It’s estimated that up to a third of people with type 1 in England and Wales could be eligible for the drug.

The approval comes from the National Institute for Health and Care Excellence (NICE), who will publish more detailed guidance following standard appeal procedures in August.

Currently, the only treatment for type 1 diabetes is insulin, which has to be injected or infused through a pump. However, it can be very tricky to balance insulin with a number of other factors, such as food, exercise and illness, and sometimes insulin therapy alone does not manage blood glucose effectively.

https://jdrf.org.uk/news/breaking-news-first-oral-drug-for-type-1-diabetes-is-set-to-be-offered-on-the-nhs-as-additional-therapy-to-insulin/


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## everydayupsanddowns (Jul 12, 2019)

“The drug will therefore only be offered as an option to those who find managing blood glucose levels challenging”​
Made me smile!

Though the additional risk of DKA isn’t ideal.

I also wonder why there’s a BMI criteria, and what effect the drug has on weight. Is it associated with weight loss in T2?


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## KookyCat (Jul 12, 2019)

I’d guess the weight loss is because it makes you shed glucose and since everything ends up at glucose in the end you can’t absorb a good proportion of the energy consumed....but why the DKA connection, would they reduce insulin consumption and sub in some dapagliflozin?  I’m confused as to how that would work, because we match insulin to carb on the basis of carb conversion rates to glucose, so you’d have to balance that incredibly carefully.....wouldn’t you?  Enquiring minds need to know


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## nonethewiser (Jul 13, 2019)

Nowt comes without some risk, that is life.

Pity it isn't a pill to replace insulin, how that would be nice.


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## everydayupsanddowns (Jul 13, 2019)

More detail in the NICE press release 
https://www.nice.org.uk/news/articl...lozinfad&utm_medium=social&utm_source=twitter


Including the guideline that it should be at least 0.5u/kg of body weight per day.


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## mikeyB (Jul 14, 2019)

Wouldn’t touch it with a barge pole. And if you are peeing out all the glucose, how do you treat a hypo?

Anyway, it’s hard enough as it is for me to get to the loo in time without additional peeing.


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## Bruce Stephens (Jul 14, 2019)

mikeyB said:


> Wouldn’t touch it with a barge pole. And if you are peeing out all the glucose, how do you treat a hypo?



Presumably you're not peeing out _all_ of the glucose, but I guess it might be harder to treat a hypo.

More significant seems to be (from the NICE note) that it's not that effective:

At present, dapagliflozin with insulin is considered to have only modest benefits based on the evidence from clinical trials. These showed small improvements in blood glucose levels and weight loss, and very small improvements in quality of life. NICE’s independent appraisal committee however highlighted an unmet need for interventions that help people to reach good glycaemic control without complications.​


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## Eddy Edson (Jul 14, 2019)

I don't get these drugs. The data I've seen suggest a mean HbA1c reduction of < 0.5% (ie 5 mmol/mol). I think they're being promoted for T2D mainly on the basis of CV benefits, which look more interesting than their BG management effectiveness, but you get some commentators suggesting you'd get the same benefits from a cheap diuretic ...


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## Robin (Jul 14, 2019)

Well, it’s a good incentive for me to keep my weight and my glucose levels down, then, the punishment being permanent Thrush....


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## KookyCat (Jul 15, 2019)

Still none the wiser about how this really helps, but I’m generally biased with any medication where there is risk that isn’t at least 75% mitigated by potential benefit.  I wouldn’t qualify on any front, but I like to know about these things in case they’re ever needed.


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## Eddy Edson (Jul 15, 2019)

... but fails to get approval for T1D in the US.

https://www.reuters.com/article/ast...da-approval-for-type-1-diabetes-idUSL4N24G19U

(Farxiga = Dapagliflozin)

Good on the FDA for standing up to Big Pharma!

Kidding, sort of, but if you were of a mind to go looking for Big Pharma malarkey, SGLT2 and DPP4 inhibitor drugs might be a good place to dig (anyway, better than statins, from which Big Pharma makes little or no money now).

Eg: This debate https://www.medscape.com/viewarticle/910861#vp_3  between the ACP and ADA over HbA1c targets. The ACP last year came out with controversial new guidelines, recommending a general 7% - 8% range for T2's, based on an analysis of costs, benefits and harms. They say, for most people, once you get HbA1c down to 6.5% you should reduce or stop medication: the costs and harms outweigh the benefits. 

They were criticised for not taking new SGLT2 and DPP4 inhibitor drugs like Farxiga into consideration, particularly for their claimed CV benefits (the ACP said not enough good data yet).  In the debate the ACP guy was skeptical about the cost-benefits claimed for these drugs, implying that he thought the analyses were influenced by the pharma companies.

Check the disclosures.  ACP guy: nothing to declare.  ADA pro-SGLT2/DPP4 guy:

_Buse has reported receiving research support from, owning stock in, and/or being an advisor for Adocia, ADA, AstraZeneca, Dexcom, Elcelyx, Eli Lilly, Fractyl, Intarcia, Lexicon, Metavention, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, NovaTarg, Novo Nordisk, Sanofi, Shenzhen Hightide Biopharmaceutical, VTV Therapeutics, Boehringer Ingelheim, Johnson & Johnson, National Center for Advancing Translational Sciences, National Heart, Lung, and Blood Institute, Patient-Centered Outcomes Research Institute, and Theracos.
_
EDIT: Noting also that AstraZeneca had Farxiga sales of $1.39 billion in 2018, and the drug is generally seen as critical for A-Z's future.


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## silentsquirrel (Jul 15, 2019)

I seem to remember quite a while back alarm bells being sounded about this type of drug being used for T1s, with several scary cases of people being diagnosed with DKA, not recognised early as ketones were very high but bgs were relatively normal?


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## Ljc (Jul 15, 2019)

I can’t see how it would be easy to calculate insulin units to carbs  with this drug, hypo central springs to mind,  thrush ugg.  I too remember reading about DKA not being recognised early due to BGs being near normal,


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## Northerner (Jul 15, 2019)

A better plan would be to give people Libres and educate them more about what the graphs/patterns mean and how to improve them  I've already made improvements in less than two weeks from looking at the impacts of food choices and when to pre-bolus  I've encountered a lot of people over the years who actually trust novorapid to start working almost immediately, rather than an hour after injecting as it often does with me!  

I suppose if being overweight as a T1 brings insulin resistance and high doses then those high doses themselves become less predictable as absorption rates can be affected, so perhaps the addition of another medication that can reduce dose amounts is sensible in some cases, but as I understand it metformin is already employed in such cases


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## Eddy Edson (Jul 15, 2019)

SGLT inhibitors and DKA risks: http://www.diabetesincontrol.com/caution-for-using-sglt-2-inhibitors-in-type-1-diabetes-ada/


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## Matt Cycle (Jul 15, 2019)

Still not sure what the point of this is.  Is it something to do with weight loss as they're only giving it to fat people.  I wouldn't get it anyway but I don't want an increased risk of DKA.


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## silentsquirrel (Jul 15, 2019)

The benefit would need to be huge to outweigh the potential side effects.


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## Bruce Stephens (Jul 15, 2019)

Northerner said:


> A better plan would be to give people Libres and educate them more about what the graphs/patterns mean and how to improve them



I presume they think that for some people, "take this pill once a day and reduce your insulin doses a bit depending on BG" is more practical than using a Libre. (And, coincidentally, about half the price, not including education and other support.)

I imagine having more glucose in your urine is rather good for developing UTIs, so that ought to be included in the cost, but even so, maybe it works out for some subset of insulin users. I'm a bit surprised the number could be as high as 90000, though (which is what, 20% or so of the T1 population in the UK).


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