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.
Intensive blood sugar control - dangerous in type 2 diabetes?
You may have seen the news about changes in the ACCORD Trial. This is a clinical study of adults with type 2 diabetes who are at a higher risk for cardiovascular disease.
Some of the people in the trial were following an intensive approach to managing their blood sugar. The aim was to keep their A1C results below 6%. Others in the trial were following a 'standard treatment' with a target A1C between 7% and 7.9%. This second range is much closer to what most people with type 2 diabetes achieve.
Over 10,00 people were taking part in the trial. Over about a four year period 257 people in the intensive group died, compared to 203 people in the standard treatment group. This was equivalent to 3 additional deaths per 1,000 participants per year. And both of these death rates were lower than similar populations in other studies.
About half of the additional deaths were due to cardiovascular disease, the rest were from other issues such as cancer. But it's not clear why these happened.
Because of safety concerns about this increase, the NHLBI who sponsors the trial has decided to stop using the intensive treatment approach and have all participants use the standard one with it's less demanding A1C goals.
If you want more information about the trial and what has changed, the NHLBI has an excellent FAQ page.
And remember, if you have type 1 diabetes, these findings don't apply to you. You should still aim for the best blood glucose control you can safely achieve.
Update: Kelly Close of Close Concerns has a good blog post about this trial, it's also worth reading.
The ACCORD Trial has its own web site, which gives more details about what the study was attempting to find out. From this page you can see that 5,128 people were in the intensive blood glucose control group and 5,123 people were in the standard blood glucose control group.
If you'd like to see other coverage of this situation across the diabetes internet, the diabetes search engine returns a lot of interesting hits for "ACCORD trial".
Technology review has an interesting article about a new compound that may soon be tested as a treatment for Type 2 diabetes.
The drug is being developed by Sirtris Pharmaceuticals. It's essentially a super strong version of resveratrol, which is normally found in plants and is contained in red wine.
The drug activates an enzyme called SIRT1 possibly producing an effect in the body that's similar to reducing caloric intake substantially.
Tests on mice with the new compound found the drug "improved insulin sensitivity and blood glucose levels in three rodent models: diet-induced obese mice, genetically obese mice, and a rat model of type 2 diabetes." According to the article clinical testing may start in 2008.
I've recently started drinking an occasional glass of red wine because of the possible health benefits. Maybe in about five years I can just pop a pill instead! Though I think I'll likely stick with the red wine.
My aging Minimed 512 is due for replacement in September. This time, I'm planning to evaluate up to three models before deciding on the right one for me.
And tomorrow, I'm going to be fitted with a Cozmo 1800 insulin pump for a trial run. I'll be wearing it for a week or two with saline and testing it out.
What I've already heard about the Cozmo from friends is that it's a little bulky but very easy to customize.
I've also asked for the software that goes with it. And I'll blog about my impressions with both.
Because I don't see the software as an add-on for the insulin pump. It's an integral part. After all, what use would your iPod shuffle be if you didn't have iTunes? Probably you could use it as a door stop. Otherwise it wouldn't be worth all that much.
I'll post tomorrow about how the 'training' and first priming goes for me.
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.
