Novo Enters Phase 1 Test of an Insulin Pill

The quest to find a way to deliver insulin without the pain and inconvenience of needles, pens, and pumps is a long one.

| Dec 24, 2009

Denmark-based Novo Nordisk A/S has begun phase 1 testing of an insulin pill that, if successful, could replace injections as the primary means of blood sugar control for millions of people with type 1 and type 2 diabetes. The company has enrolled 80 volunteer German test subjects in the study and expects to have preliminary results by the first half of 2011. The test group consists of both people with diabetes and people without it.

The quest to find a way to deliver insulin without the pain and inconvenience of needles, pens, and pumps is a long one. Novo's experiment comes almost three years after Pfizer, Inc., withdrew Exubera, an inhaled insulin, from the market after it failed to build a following with patients or healthcare professionals.

Any method that involves administering insulin orally must overcome the ill effects of saliva and digestive juices on insulin's relatively delicate molecular structure. The problem is keeping the hormone intact until it can get far enough into the system to enter the bloodstream. Novo's approach uses a patented drug delivery system called gastrointestinal permeation enhancement technology (GIPET), which helps the gut absorb insulin.

Developed by Novo's Ireland-based R&D partner, Merrion Pharmaceuticals, GIPET works by adding patented absorption enhancers to a heavily coated pill containing insulin. After the pill is ingested, the coating protects it until it can reach the duodenum, the first section of the small intestine, just past the stomach. There, as the pill begins to dissolve, the absorption enhancers quicken the passage of the drug across the duodenal cell membrane and into the bloodstream. 

In 20 clinical studies across a range of drugs, GIPET increased oral drug absorption up to 46 times in some cases. Novo's test will investigate the drug delivery's safety and effectiveness, as well as test subjects' tolerance to insulin delivered in oral form.

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Sources:

Novo Starts First Insulin Pill Test in Bid to Replace Injection

Novo Nordisk starts trial with oral insulin analogue

 

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Categories: Blood Sugar, Diabetes, Diabetes, Insulin, Medications, Novo Nordisk, Type 1 Issues, Type 2 Issues


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Comments

Posted by Anonymous on 25 December 2009

And how long will it be b4 my child can use it ?
Another dam 10 years ? pff

Posted by Anonymous on 25 December 2009

I have to agree with anonymous how many more years do we have to wait for this "pill"to be introduced to the public. Type 1's are always getting the short end of the stick and I am sick and tired of this bull.

Another concern is once this "pill" is introduced will this cancel the potential prospects for a "cure" for type 1 ? Is this just a ploy for phamaceuticals to rake in billions of dollars more??

Lets be honest folks the costs in the treatment for Type 1 & 2 Diabetes is a big big "cash cow" for numerous individuals and companies alike. Such as Pharmaceutical industries who manufacture insulin and other Diabetic supplies such as pumps,sryinges,glucometers, and so much more. The individuals Treating T1 & T2 are Endocrinologists,family physicians, Nurses and so much more. That being said do you still think the cure will be on its way? My answer: No way!

I was diagonsed with Type 1 diabetes 20 years ago. The "twit" that treated me at the time assured me the cure will be available in 5-10 years. Well I have this for 20 years what happend???? Did the reseachers fall asleep or were they paid off by the Pharmaceutical industries to keep their mouths shut.

Insulin was discovered in 1921 which involved injections we are entering 2010 WE ARE STILL USING INJECTIONS. WHAT IS WRONG WITH THIS PICTURE?????? THIS IS NOT NORMAL!!!!

Posted by Jerry1423 on 25 December 2009

I would love to see something like this happen, but I wonder how the amount of insulin is controlled, like it is controlled in a syringe.
They need to hurry up with this because companies like these will have less money for research because more government controls on our health care.

Posted by shosty on 26 December 2009

I don't see how something like this can work. The pump delivers minute, and very precise (to the 10th place or even more precisely), amounts of insulin continuosly, with very precise boluses for food.

The pill would release insulin all at once, I am assuming, rather that in an extended way, and with the absorption issues, precision would be impossible.

Posted by shosty on 26 December 2009

I don't see how something like this can work. The pump delivers minute, and very precise (to the 10th place or even more precisely), amounts of insulin continuosly, with very precise boluses for food.

The pill would release insulin all at once, I am assuming, rather that in an extended way, and with the absorption issues, precision would be impossible.

Posted by Anonymous on 26 December 2009

In response to the second Anonymous posting: I was diagnosed 45 or 46 years ago, and have been waiting the same promised "10 years of a cure".

If one was available now, I don't know that what the years have done to my body would even allow me to qualify. I thoroughly agree that a cure should be available, and wonder about collusion among pharmaceutical companies.

But I also think about how little we know about the complex chemical interactions that take place.

It would be beyond my wildest imagination to live like a "normal" person, it truly would. Just think, pizza without compensating the best that you can; leaving the house without all of the spare parts to back up your pump (it really is amazing that you just get up and go, you have to remember all of the gear "just in case"). But, the pump has radically changed my life, and it will have to do for now.

Maybe by 2020 .....

Posted by Anonymous on 26 December 2009

Here is yet another means for the Pharmaceuticals to continue making billions of dollars off diabetics, the main reason there is yet to be a cure. R&D occurs when they can substitue one means of making money for another. The pain associated with needles or pumping is minor compared to the inevitable long term complications that eventually catches up to Diabetics, including those well controlled.

Posted by Anonymous on 26 December 2009

I have some concerns about any side effects this might have on the human digestive system. Second, the body derived insulin last about 3 hours. How is this drug going to mimic the body's own? What is the molecular structure of this ingested insulin? We definitely need some questions answered before we blindly give this to diabetics. We must be careful of any deceit and any manipulation of the powers that be in getting this approved.

Posted by Anonymous on 27 December 2009

I am sure the ingested insulin will be for basal dose (12 or 24 hour) and we will continue to have to compensate in other ways, injections or pump, for meals. It would eliminate one out of eight injections (5 insulin and 3 symlin) a day for me. Ho-hum.

Posted by Anonymous on 27 December 2009

That would be wonderful to not have to worry if my bolus wasn't enough,or if my basal rate is changing and all those things you have to take care of when you are pumping.Don't get me wrong the pump is a fantastic tool that has changed my life as a diabetic.I hope that this isn't just another discovery that gets thrown out.

Posted by Anonymous on 27 December 2009

Three hurras for the scientists in Novo NordisK!!!!! I, as the parent of a 15-year old DBM1 teen am looking forward to have this wonderful pill in the market as soon as possible to ease the life of those with DBM1 that are insulin-dependent patients. Hope we do not have to wait 10 more years to have it in our hands!!!!!

Posted by Anonymous on 28 December 2009

My, the comments are bitter this morning. You are not 1 of the 80 volunteers so you are probably safe from unanticipated diffculties. For people with disabilities, a series of colour coded pills to control type 1 and type 2 diabetes that requires insulin would be life-changing. It would probably be less expensive than the present pump delivery with bg testing method and less cumbersome. Envision it! For breakfast a black long-lasting insulin pill and a red pill to cove 66 g. of carb. In 2 h. maybe a pink pill to reduce the bg a bit. The CGMS woujld help you out in determining what pill to take as would bg metering. I'm assuming, of course, that the insulin is absorbed as quickly as the insulin infused from a pump.


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