Ramblings of an old Doc
Published on February 13, 2013 By DrJBHL In Personal Computing

 

A while back I believe I wrote about this development. Correct, it isn’t Personal Computing, but it is personal for many… too many. Some members of the community have asked me to write about diabetes, especially. So, since this a request, here you go. I tried not to make it too technical/boring.

A little background. Insulin is produced (naturally) in the pancreas. Its main function is to facilitate glucose’s entry into cells where glucose is metabolized for energy. Insulin does other things, as well, but they’re not in the scope of this article.

Two Canadians, Frederick Banting and Charles Best conducted research and found a method for extracting and purifying Insulin from pig pancreases. This was a truly giant step forward for medicine and mankind, because without functional insulin (or an equivalent to stimulate more Insulin secretion) people sicken and die. People of all ages. They truly deserved the Nobel Prize in Medicine for their work.

Up until now, the method of delivery for Insulin was by injection (or pump which is a form of injection). Many find that less than optimal because of the syringe, even though the needle itself is so thin it’s barely felt. There is a risk of infection with injection, also. There are also folks with fears of needles which interferes with their lives and the treatment.

Anyway, a revolutionary oral treatment may be coming fairly soon to market. Oramed Pharmaceutical’s Insulin pill is entering Phase 2 studies.

Some definitions:

  • What are Phase I, Phase II and Phase III studies?
  • The phase 1 study is used to learn the "maximum tolerated dose" of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.

    The phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.

    The phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult. Determining the true benefit of a drug in a clinical trial is difficult.

    What this means is that the pill/medicine has passed its Phase 1 studies. Good news. The pill isn’t at your pharmacy yet. But hopefully, if it does well in phase 2 studies it will be coming.

    Oramed's oral insulin is indicated for the early stages of T2DM, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite.

    What’s even better is that having such a pill instead of an injection will increase the patient’s compliance with treatment early in the disease, hopefully decreasing and possibly eliminating the complications of diabetes type II (“adult” onset diabetes). ORMD-0801 (the drug’s technical designation) has also been proposed as a supplemental treatment in type I (“juvenile” diabetes, the autoimmune variety of the disease). Both types of diabetes can occur at any age.

    Source:

    http://israel21c.org/headlines/groundbreaking-insulin-pill-nearing-market/

    http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml

    http://www.oramed.com/index.php?page=14


    Comments
    on Feb 13, 2013

    Good news indeed.

    on Feb 13, 2013

    This is good news, I hope it becomes available in Australia soon after its US approval.  While my type 2 diabetes is being controlled by Diabex, it may be that I could need Insulin further down the track, and while I have no fear of needles, or giving myself one, the oral dose would appeal to me more... ie, more convenient/easier to administer.

    on Feb 13, 2013

    I do insulin shots 3 times daily. I am very tired of needles and it's kind of a hassle when out. Unless I carry it with me at all times, then unscheduled meals (which are sometimes unavoidable) means I take my base rate after eating, rather than the base rate and a sliding scale 30 minutes before eating.

    Not the best scenario.

    Pills I could easily carry with me when I'm out.

     

    Good news indeed, hopefully to be here soon.

    on Feb 13, 2013

    Jim, there is another option: An insulin pen: https://en.wikipedia.org/wiki/Insulin_pen

    Granted, it's really just a slightly different form of injectable insulin, but it saves carrying syringes and bottles. The cartridges come in R and N and premixed (70/30)... Hopefully the tablets will alleviate a lot of the hassle for you.

    on Feb 13, 2013

    DrJBHL
    Jim, there is another option: An insulin pen: https://en.wikipedia.org/wiki/Insulin_pen

    Granted, it's really just a slightly different form of injectable insulin, but it saves carrying syringes and bottles. The cartridges come in R and N and premixed (70/30)... Hopefully the tablets will alleviate a lot of the hassle for you.

    Yeah, the pen is nice, used it, but it cost's more.