Oral Insulin as a New Horizon

Recently, a friend of a friend was talking to me about oral insulin and how it might be used in a person with type 1 diabetes mellitus. I wrote him a lengthy letter back and thought many of the comments were good to put here as well.

To start, I want to say that there are many opinions out there. What I think is just another opinion, but I also give information and answer questions with facts and references.


Oral insulin (insulin in a pill) is a target for several pharmaceutical companies focused on diabetes medication. Basically, insulin is a small protein that acts as a hormone to regulate sugar metabolism. Generally, diabetics that need insulin will take a shot (ouch!). Insulin doesn't come in a pill form because just like most proteins, the stomach acid breaks insulin down before it can get into the bloodstream to do its job. The idea behind oral insulin is that there may be a way to package insulin in a pill to protect from being destroyed and help save all those diabetics from having to take shots or wear insulin pumps. Will it work?

Oramed sure thinks so...
Oramed (http://oramed.com) is led by Miriam Kidron, Ph.D of Israel. The company was founded in 2006, so it's relatively young, but Dr. Kidron was been a Researcher in the Diabetes Unit at Hadassah University Hospital in Jerusalem, Israel, since 1990. She's been a busy biochemist! (Forbes blurb on Dr. Kidron)

It may not seem important, but I always check the history of groups in diabetes care. Many times, I have seen very small groups come up with "ground-breaking" ideas that just don't end up working or have the support to continue. They are still worth learning about in my opinion... and even supporting! But, if you're looking for a proven treatment, they may not be the best place to go, in my opinion.

Oramed makes and studies the oral insulin ORMD-0801 (drug info from their site). They finished Phase II (clinicaltrials.gov results) on 12 people with Type 1 Diabetes Mellitus (T1DM, the type that is dependent on insulin shots). You can also read about the results in the open access journal PLoSOne (Glucose-Reducing Effect of ORMD-0801).

Novo Nordisk is a separate and much larger pharma company (I won't go into detail on Novo because it is so massive) also working on several oral insulin variations. OI338GT (NN1953) is top of their pipeline at the moment I believe. They finished a Phase I trial in 83 healthy people last October and they're looking to move up in the game for T1DM and type 2 diabetes mellitus (T2DM, the type frequently associated with heredity and obesity) as well.

This is my interpretation - oral insulin may be useful to a smaller subset of T1DM patients that have uncontrollable or brittle diabetes. It may help with rapid unexpected high blood sugars that some people encounter. But it seems much more likely that oral insulin will be useful for T2DM. For T2DM, oral insulin may be able to regulate when basal insulin production is low, but only because the patient has functioning cells and complete endocrine system (even though it may be diminished or may have trouble responding). It also would be difficult to only use oral insulin in T1DM because the frequency and precision needed to hit target blood sugar ranges. It would also become very difficult if that's all you wanted to take. You would most likely need other forms of insulin when you eat or have high blood sugar.


And on that note, there are many types of insulin and delivery systems for insulins that have varying time range of activity. Go to the bottom of this wiki page on anti-diabetic medications and you'll see there are many insulins. Tresiba lasts up to 40 hours (fairly new). Levemir is somewhere near 30 hours active time. And Lantus has been a standard in T1DM care with a near peakless activity for 18-24 hours (nearly perfect for once a day!). So there doesn't seem to be a huge market for oral insulin with T1DM in my opinion.

I don't know if oral insulin will be the future of insulin therapy for T1DM, but I do think that even with continued successes, it will take well over a decade to perfect. In the meanwhile, insulin pump therapy and multiple daily injections are the most widely known and accepted routes to diabetes care and maintenance.

There is also a lot of work being done on vaccines and antibody therapy that if you use at the beginning of diagnosis can limit the severity of T1DM and prolong the "honeymoon stage". I am not an expert on this topic, but I would strongly suggest your relatives look into it with their endocrinologist. If they are able to slow the progression of T1DM in your neice, even for a few years, it would be incredible. I would have paid so so so much money if I could have postponed full-fledged T1DM for an extra 5-10 years. Here is a book chapter I've started reading into recently (Antibody-Based and and Cellular Therapies of Type 1 Diabetes).

There are maybe 5-6 major insulin pumps out there (a few more in much smaller markets). I have used the Medtronic Paradigm since 2009. I'm always happy to share my experience. Insulin pumps are incredibly precise, but many people avoid using them in the first years after diagnosis because of cost, burden to carry and because the severity of T1DM is typically lower during the "honeymoon" period.

I have had several people tell me that once they have trouble managing blood sugars, they will start an insulin pump therapy, but not before. Of course, it is standard protocol for endocrinologists to offer an insulin pump. I personally know the doctors can be very pushy about this topic. I just wanted to point out that many T1DM patients live very well with the much lower cost multiple daily shots with insulin pens.

In fact, I think it's good to go on a "pump vacation" periodically. You never know when your pump may break and you will have to rely on shots until it is replaced. Always be prepared!