The capsules are being tested at Hadassah Medical Center in Jerusalem on 10 patients with type 2 diabetes.
Phase 2 is where potential drugs are tested to see if they're safe and they work (efficacy). The capsules will need to complete a phase III trial before they can be sold to people with diabetes.
The main challenge to taking insulin by mouth is that the insulin protein is broken down in the stomach before it has a chance to be used by the body. Oramed claims to have solved this problem and the challenge of getting the insulin through the walls of the intestine.
Prof. Hanoch Bar-On, a leading Diabetologist on the Oramed team, states that the route of the insulin from the swallowed capsule “imitates nature” in that it passes to the liver and then to the bloodstream. Injected insulin goes straight to the bloodstream.
I've been unable to get any information on dosing (figured out in phase 1B) or the duration of insulin delivered by the Oramed capsule. I hope to get this after phase 2A is completed. It took Oramed about seven weeks to complete phase 1B, so this information may be available sometime after mid-June.
Oramed is planning to get approval first in the US and then Europe.
In addition to their oral insulin capsule, Oramed is also working to develop an insulin suppository. This product is in Phase 1 trials at present.
Update: I exchanged some e-mails with Oramed. They told me that the phase 2a trials are 'expected to last a few months'. Also that while the trials are on people with type 2 diabetes the product may be usable by people with type 1. I'll post again once I have more news.
I've had type 1 diabetes for a long time and I've spent much of that time hoping for, and thinking about, a possible cure for diabetes. But I'm also very interested in the research that JDRF is doing on an artificial pancreas.
I can understand how a closed loop between a continuous glucose monitoring system and an insulin pump could work to control my basal (background insulin) rate. But I really didn't see how it might also be possible to effectively give boluses (larger doses for meals or BG correction) with such a system.
Yesterday I stumbled across a short paper in Diabetes Care, Detection of a Meal using CGM. The authors describe a Meal Detection Algorithm that allows them to detect a meal about 30 minutes after the person has started eating!
It's not perfect - but we already know that's true for most of diabetes care. Uf this brings the Artificial Pancreas a little closer and make diabetes treatment a little easier, I'll take it.
Insulin is not a cure. But automatic insulin delivery is a step in the right direction.
Update: There will be a workshop with updates from the artificial pancreas project in late July 2008.
Researchers have been able to get liver and pancreatic cells in diabetic mice to produce insulin by using a naturally occurring protein. According to the article I read, by injecting a protein called Pdx1 into the abdomens of mice, insulin production is restarted in the mice. Pdx1 has a structure that allows it to pass into the pancreatic cells, enter their nucleus and cause insulin production to start.
According to Dr. Li-Jun Yang, founder of Transgeneron Therapeutics, "What is remarkable is that the protein also promotes regeneration of insulin-producing cells in the pancreas, allowing the diabetic mice to become normal."
It all sounds like it has possibility. I'd just caution readers not to get too excited.
This is research and I'd guess it's many years away from any kind of application for people with type 1 diabetes.
Diabetes365 day 14 October 21, 2007 - Uisce Beatha
On an average day I take about 30 units of insulin. That's 1-3rd of a CC, or about 1/8th of a teaspoon. If you're a baker you know that's half the amount of nutmeg that you'd put in one apple pie.
It's a really small amount of liquid but for me it's essential to life. I think of the Irish for whiskey - uisce beatha or the water of life.
Because I have Type 1 diabetes, insulin is my water of life. If I wasn't able to take this small amount of precious fluid every day, I'd get extremely sick and die within a few weeks.
Because I have a broken pancreas I physically carry insulin with me every day of my life.
To control my type 1 diabetes, I use an insulin pump instead of taking injections.
Before each meal I use the pump to take additional insulin to cover the carbohydrates that are in the meal. The rest of the day (the whole 24 hours), the insulin pump delivers a small background dose (basal) of insulin.
And that's what normally happens for me. But this morning I was woken abruptly at 2:50 AM by a loud beeping and buzzing.
My insulin pump was displaying the error message No Delivery, which meant that it wasn't delivering insulin to me.
So I:
Get out of bed to capture this photo.
Get rid of the error message on the pump.
Take additional insulin to cover my blood glucose level (around 220 mg/dL).
Drink lots of water.
30 minutes later I'm back in bed asleep. Unlike my diabetes, which never sleeps.
You probably have seen the news on this from other blogs. The first I read about it today was on Scott Strumello's blog this morning.
Exubera is the inhaled insulin that Pfizer has been has been working hard to get people with diabetes to use. And I've always believed this would be a hard sell. There's not enough information about the long term consequences of inhaling this very new drug. And the inhaler itself has been commonly referred to as a bong, almost from the day it was released. This is one case where getting a true design team in to think about making something acceptable for most users would have helped a lot.
Anyway, there's a lot of news out there about this cancellation and I wanted to point out some of them. The Wall Street Journal Health Blog has several interesting posts:
Despite what I thought about the delivery mechanism, I did like the idea of a novel form of diabetes treatment. We're treating diabetes in the same way that Banting and Best did in the 1920s. Insulin is now purer and our dosing is more accurate, but otherwise not much has changed (except for Symlin/Byetta).
I do hope that this doesn't discourage drug makers from looking at other ways to help us treat and manage our diabetes. It would be a terrible shame if this decision by Pfizer had that kind of an effect.
I couldn't resist this. Apparently B&O has a division called Medicom. They've designed a new inhaled insulin delivery device called the Insulair
This is clearly meant to steal the huge market share of the Exubera insulin bong. Personally I think the issues with the Exubera was the silly marketing name. Why not just come out and call it the exuberant bong. I can see the name designers say "We can use the slogan - Get a hit from your insulin!". Hah
B&O is well known for their product design, I can't help thinking this one might actually stand a chance. Though from a Google search it's not clear whether this is just a design concept like the Charmr or a real product that's not yet available.
Diabetes365 day 5 Oct. 12th 2007 - Diabetes Detritus
Diabetes is a high maintenance disease - it takes a lot to replace a working pancreas. For today's picture I took most of the stuff out that I either carry with me, or have as backup in my office.
As you can see, there's a lot of stuff there.
When I was a child I was into all sorts of gadgets. Now I get to live with these on a daily basis.
The standard cry when we're leaving the house to go anywhere is "do you have your kit" or "Dad can't find his kit". And everyone knows it's the Eagle Creek black bag that has all my stuff. We don't leave home without it.
All of this technology is needed to replace my non-working pancreas. I'm thrilled that it exists and that I have the health insurance coverage to afford it. But I'd trade it in for a real pancreas any day of the week.
Unfortunately currently there isn't a cure for diabetes. But I do my best to support the research for a cure.
For now, I'm trying to take diabetes365 photos at slightly later times in my diabetes day. At some stage, I'll switch to a different approach to documenting what it's like to live with diabetes 24 by 7 by 365.
I have a small scales at home that I use mostly for breakfast. Most packaged food now has nutrition labels which lets me see the carbohydrate content for a specific weight. By adding the carbs for all the foods together and using an insulin to carbohydrate ratio (I:C) I can figure out how much insulin I need to take. The I:C value is different for everyone with diabetes, it can even vary for the same person at different times of the day.
I've been using Symlin for about a year. It's a drug that's I inject shortly before meals. It slows down the release of food from my stomach and makes me feel full. Both contribute to better blood sugar control, though it can cause terrible low blood sugar reactions.
Insulin (and Symlin) are not cures for diabetes. They just allow people with diabetes to control their blood sugars.
Today is D-Blog day, an opportunity for the diabetic bloggers to try and get the word out about diabetes and trying to live with it (or perhaps to live despite it).
If you've heard about diabetes, you've certainly heard about insulin. That wonderful hormone that's produced by your pancreas and that does an excellent job of regulating your blood sugar - that is if you don't have diabetes.
If you do have Type 1 diabetes, then your pancreas is dead, it's a stiff, it has passed on! OK, I'm going overboard a bit but your pancreas doesn't produce insulin anymore.
No problem, you say, you can just get it and inject it. If only it was that simple.
Insulin is not a cure.
In the 1920's Banting and Best first 'discovered' insulin. Shortly afterwards companies starting making insulin using chopped up cow and pig pancreases. Sounds kind of gross, huh?
Guess what... Things haven't really changed all that much since then.
Insulin manufacturing is a bit better. And insulin delivery devices are much better. We've gone from testing urine to testing blood to determine how much insulin we need. Neither of these options was available in the 1920's.
But for the most part, not a lot has changed since then.
For most people going on insulin is really a long-term sentence. Sentenced to a life of:
Daily blood sugar testing.
Daily worrying about long-term complications.
Daily calculation of the amount of food you're eating.
Daily concerns about exercise, sickness, emotional swings.
Despite all of this, most folks that I know who have diabetes are remarkably upbeat, and have accomplished all the 'normal' things that others do with their lives.
My question is: why does it have to be so hard?
This is not a trivial disease. According to estimates at least 1,000,000 people in America alone have Type 1 diabetes.
If each of these are testing their blood sugar 4 times daily, then this amounts to 4 million test strips a day at an approximate cost of $2 million every day, or three quarters of a Billion dollars every year spent in America just to test our blood sugars.
Now add the cost of syringes, insulin, alcohol swabs, pump supplies, glucagon, ambulance rides, eye treatment, kidney treatment, amputations, etc., etc.
Have I got your attention yet?
If we got serious about working on a real cure for diabetes, not an improved form of treatment, imagine the cost savings. Imagine what all those wonderful people would do when released from the burden of caring for their diabetes.
What are we waiting for?
So here's my call to action.
Why not write to your legislator and ask them if they support increased National Institutes for Health spending on research towards a diabetes cure? That might get the ball rolling.
Diabetes: technology, devices, software, and other stuff.
About Me
Name: Bernard Farrell
Location: Massachusetts, United States
I was born in Ireland and now live in the US.
I have had Type 1 diabetes for over 35 years. I struggle with my blood sugar, the same as most people with diabetes.
I wear a Cozmo 1800 insulin pump and a Dexcom SEVEN CGM to track my blood glucose levels. I also take Symlin to help control my post-meal blood sugars.
I'm blessed by God, and every day brings the possibility of a cure.
