Galvus FDA application accepted

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    Galvus FDA application accepted


    Galvus® – a revolutionary treatment for type 2 diabetes


    On March 30, Novartis announced that the new drug application for Galvus was accepted for review by the FDA. If approved, Galvus will provide a new once-daily oral treatment option for people with type 2 diabetes. Submission for approval in Europe is on track to be completed later in 2006.
    In clinical studies, Galvus has demonstrated significant reductions in blood sugar, sustained for one year. Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. Galvus was not associated with overall weight gain, a key benefit for people with diabetes who struggle to keep their weight under control. The overall incidence of side effects with Galvus, including hypoglycemia (excessively low blood sugar) and edema (fluid retention), was similar to placebo.
    Galvus, a DPP-4 inhibitor, works through a novel mechanism of action, targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. Galvus affects both pancreatic alpha and beta cells, leading to a reduction in sugar production from the liver, together with an increase in production of insulin needed to keep blood sugar under control.
    About diabetes
    • In most developed nations, diabetes is the fourth leading cause of death.
    • Diabetes currently affects about 195 million people worldwide and is estimated to grow to more than 330 million by 2025.
    • While the disease burden among Western nations is great, it is estimated that, in the developing world, the cases of type 2 diabetes will increase by 170% by 2025.
    • Type 2 diabetes is a progressive disease, where control of blood sugar deteriorates over time.
    • Diabetes can lead to heart and kidney disease, blindness, and vascular or neurological problems, which can result in amputation.
    • More than half of those currently taking medication to manage their diabetes are still not reaching their blood sugar goals.

    For more info on it, look up vildagliptin or LAF237 on pubmed.

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    DPP-4 inhibitors work like this:

    There is a hormone in your body which tells your body to stop producing insulin. Galvus (vildagliptin) inhibits that hormone. This in turn allows your body to produce the proper amount of insulin in response to food.

    It has a tremendous safety profile; even better than metformin (Glucophage XR). It can also be used in conjunction with metformin for added benefit.

    Obviously anyone who knows anything about insulin as it relates to bodybuilding can see how this could benefit those who are interested in it for anabolic purposes.
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    Sounds like great news for diabetics. Contrary to popular belief, I am happy when a good drug comes along..particularly when they are as nuanced as this one. This will help a lot of people.

    Assuming many BBers ahve an already optimized metabolism and insulin response, I can't see where this drug will fit in exactly.
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    Quote Originally Posted by bioman
    Sounds like great news for diabetics. Contrary to popular belief, I am happy when a good drug comes along..particularly when they are as nuanced as this one. This will help a lot of people.

    Assuming many BBers ahve an already optimized metabolism and insulin response, I can't see where this drug will fit in exactly.
    Prolonged insulin response; longer anabolic window. Allows for higher threshold of insulin generation without increase in insulin resistance.
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    Ahhh, now I get it. Good post Null.
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    Let's look at a purely hypothetical example.

    All numbers here are pulled out of my butt; they are just for example.


    Let's say the maximum amount of insulin Bob can generate in an hour is 5IU. His body is fairly insulin sensitive because he's been taking DS's Glucophase and he has plenty of Taurine, Arginine, and Lysine in his diet pre-workout. So let's say his supplementation allows him to effectively pump out an extra IU. That insulin repsonse only lasts for like an hour maybe 2.

    He goes on Galvus. Now his body is able to continue cranking out insulin past the 5IU threshold and even beyond the boosted 6IU. Now his window of insulin production is extended an additional hour and he can crank out 10IU of insulin and bosoted from GXR and those aminos, he can crank out 11 or 12IUs. All the while he doesn't suffer the negative effects of insulin resistance that you get from taking slin directly.

    On top of that Galvus has a very low tendancy to trigger hypoglycemia. So so when blood sugar drops, your body has other mechanisms which decrease insulin output to prevent shock. Thus it is much safer than taking slin in that regard as well.
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    Quote Originally Posted by Nullifidian
    Let's look at a purely hypothetical example.

    All numbers here are pulled out of my butt; they are just for example.


    Let's say the maximum amount of insulin Bob can generate in an hour is 5IU. His body is fairly insulin sensitive because he's been taking DS's Glucophase and he has plenty of Taurine, Arginine, and Lysine in his diet pre-workout. So let's say his supplementation allows him to effectively pump out an extra IU. That insulin repsonse only lasts for like an hour maybe 2.

    He goes on Galvus. Now his body is able to continue cranking out insulin past the 5IU threshold and even beyond the boosted 6IU. Now his window of insulin production is extended an additional hour and he can crank out 10IU of insulin and bosoted from GXR and those aminos, he can crank out 11 or 12IUs. All the while he doesn't suffer the negative effects of insulin resistance that you get from taking slin directly.

    On top of that Galvus has a very low tendancy to trigger hypoglycemia. So so when blood sugar drops, your body has other mechanisms which decrease insulin output to prevent shock. Thus it is much safer than taking slin in that regard as well.
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    I saw this and was wondering how it could benefit us. thanks for the explaination null. I like it.
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    Do you think this stuff will be hard to get?
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    I can imagine that at first it will be hard to get.

    But, if you can imagine an "oral" replacement for insulin injections and the monetary gain possible from such then you can imagine that cheap chinese sources will come along in no time.
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    Any news on this, aka a release date?
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    i can just imagine how huge the pro's will get on this stuff, along with the new myostatin ihibitor's they are supposedly getting their hands on. using 20 iu's of insulin a day has to cause some serious insulin resistance....if they can keep pumping out the insulin while radically increasing their insulin sensitivity...well...we may be looking at a new breed of mass monster
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    not necessarily, insulin does help the pros but only to an certain degree. And even then it probably more to do with the effect it has with other items, test and GH come to mind. I don't see this being that much of an boon for armature BBers as insulin itself is not that useful for us

    I would like to see these myostatin inhibitors that are suppose to be coming, THAT would be fun to get my hands on
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