Diabetes Self-Management Blog

Editor’s note: The research described in this post aims to halt or reverse Type 1 diabetes very early in its course and does not directly apply to people who have had the disease longer than a few months. Given that limited funding is available for any kind of diabetes research, do you think this is the right place to focus research dollars? If not, what would you like diabetes researchers to focus on? And how should Type 2 diabetes research fit in? Leave a comment below!


As a medical writer who frequently covers diabetes research, I’ve never sensed so much excitement in the air about the prospect of a significant breakthrough for Type 1 diabetes. Right now, a number of approaches are being tested very early in the course of Type 1 diabetes to see if they can slow, halt, or even reverse the destruction of the insulin-producing pancreatic beta cells by the T cells of the immune system. While none of these approaches is designed to reverse long-term Type 1 diabetes, the success of any treatment could lead to valuable knowledge that may one day lead to a cure. Here are some of the more promising ongoing clinical trials I’ve come across.

The New Kids on the Block

Many researchers believe — and I agree — that it’s important to test as many potential therapies as possible, because no one really knows which agents or combinations of agents will ultimately be most effective. The following are a couple of relatively new therapies being tested for recent-onset Type 1 diabetes.

Prochymal. A Phase II trial is currently recruiting participants to test the effects of a cell-based therapy called Prochymal. The active ingredient in Prochymal is a preparation of adult stem cells collected from the bone marrow of healthy volunteers. Researchers are studying whether, after migrating to the pancreas, these cells can halt the immune attack on the beta cells so that they can remain functional and possibly even regenerate. Participants in the trial must be 18–30 years old and have been diagnosed with Type 1 diabetes between two and 16 weeks before being screened for eligibility. They will receive three intravenous infusions of either Prochymal or a placebo (inactive agent) 30 days apart. The researchers will then compare the treatment and placebo groups using a number of measurements, including C-peptide response (a measure of pancreatic function), insulin required, HbA1c level, episodes of hypoglycemia, and blood level of certain diabetes-associated autoantibodies (proteins created during an immune-system attack on part of the body, such as the pancreatic beta cells).

START. The Phase II START study is recruiting volunteers to test the potential benefits of a drug called thymoglobulin, which traditionally has been used to prevent the rejection of transplanted organs. Thymoglobulin is thought to work in at least two ways: by eliminating destructive T cells from circulation, and by altering the way the remaining T cells work. Participants must be 12–35 years old and have been diagnosed with Type 1 diabetes no more than 12 weeks before entering the study. They will receive an escalating four-day regimen of thymoglobulin injections or four daily injections of saline solution. The treatment and placebo groups will be compared based on C-peptide response.

The Front-Runners

The two most promising trials, in my opinion, are the ones testing a class of treatments called anti-CD3 monoclonal antibodies. Both of the substances used in these studies have already been tested in humans with Type 1 diabetes and have shown promising results.

Protégé. The Protégé trial is designed to determine whether a drug called teplizumab can protect the beta cells of people with newly diagnosed Type 1 diabetes. Teplizumab is intended to destroy the T cells that are attacking pancreatic beta cells, allowing a different type of T cell — regulatory T cells — to repopulate the immune system so that it tolerates the beta cells. A study reported in the journal Diabetes in 2005 showed that giving the drug to people with recent-onset diabetes improved their beta cell function, lowered their HbA1c levels, and reduced their insulin requirements.

This Phase III trial is recruiting people 8–35 years old who have been diagnosed with diabetes no more than 12 weeks before starting treatment in the study. Participants will receive daily intravenous infusions of the drug or placebo for 14 consecutive days, which will be repeated after six months. Researchers will determine whether participants who received the drug require less insulin, have a lower HbA1c level, or have a better C-peptide response than those who received the placebo.

DEFEND-1. A trial called DEFEND-1 is testing the effects of another anti-CD3 monoclonal antibody called otelixizumab. A study reported in The New England Journal of Medicine in 2002 showed that this treatment slowed the loss of insulin production and improved blood glucose control during the first year of diabetes in the majority of patients. DEFEND-1 is recruiting people 18–35 years old who have been diagnosed with Type 1 diabetes no more than 90 days before the start of the study treatment. Participants will receive an eight-day series of otelixizumab or placebo intravenous infusions. Researchers will record the effect of the drug on C-peptide response, insulin requirements, HbA1c level, and incidence of especially high or low blood glucose levels.

Should You Volunteer?

The best motive for volunteering for a clinical trial is the altruistic one — furthering the cause of diabetes research. In addition, the potential benefits for participants who end up in the treatment group of a promising drug are obvious: diabetes that is easier to control, lower HbA1c values, and a lower risk of diabetic complications down the road. However, there are benefits even for those who end up in the placebo group — namely, excellent monitoring and diabetes care by a team of health-care providers.

The major downside to trial participation is the risk of side effects. In most cases, the potential side effects of the drug being studied are well known and well monitored. However, it is important to find out about the risks of the drug you may be taking.

To search for clinical trials, log on to www.clinicaltrials.gov. Meanwhile, the Juvenile Diabetes Research Foundation is working to design a user-friendly registry that will make it easier to find clinical trials that you might qualify for.

Robert S. Dinsmoor is a contributing editor to Diabetes Self-Management magazine and a medical writer based in South Hamilton, Massachusetts.

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Comments
  1. I am the mother of a 46-year old male who has type II diabetes which he acquired after losing 40 pounds within a one-year period. He has gotten his A1c down to 6.8 and was told by his doctor that if he got it down to 5 or below, he would have his medication lowered or some discontinued.

    I volunteered to donate my stem cells to help him if that could be done. I am 71 years of age and would be more than happy to do so. Is there any other way he can be helped at this time. I was told that he is not that bad off that the performance of a stem cell implantation would not be done.

    Would appreciate a response to this dilema.

    Sincerely,

    A worried mother - Marie Spadafore

    Posted by Marie T Spadafore |
  2. OK-
    Don’t want to sound like a whiner, but after more than 45 yrs of waiting for the “cure” that was “right around the corner” I think I’m allowed my my gripe.

    Why is it that pharma-studies (especially those involving stem cells) always want someone who has “just been diagnosed” when someone like me who has endured with Type 1 diabetes for well over four decades is continually rejected from studies?

    Despite the fact that I am relatively complication free and willing to sign any decree or waiver of liability necessary for study participation, I am regularly excluded from participation in trials that might possibly provide a breakthrough in treatment.

    At this point I feel like I’m being relegated to the “scrap bin” as some sort of write-off, where I can eventually hope to be placed on a waiting list for a kidney/pancreas transplant once I’m at deaths door should one be available!

    If someone would care to actually provide informed response to this inquiry with a factual explanation I’d greatly appreciate it.

    Posted by James D.Taylor |
  3. I have Type 2 Diabetes! I should also be included in any RESEARCH that is provided! Not just Type 1!!!!!!!!!!!!!!!!! Thanks Judy

    Posted by Judy in Kentucky |
  4. James, I agree with you. for the past 33 years I have worked hard to take care of myself with Type 1 diabetes. I am basically complication free. I want to know what studies can “healthy” type 1 diabetics participate in? Don’t diabetes studies need some healthy long term type 1 diabetics?

    Why do studies only include those who have been diabetic for less than 3 months or those who are death’s door? There are many of us who have done all of the right things for decades and prove the point everyday that contentious adherence to a “diabetic lifestyle” really does work!

    Posted by Kathy McGrath |
  5. I have been hearing for most of the 57 yrs. I have been shooting insulin about the soon to-be cure. My resent A1c was 5.7.
    If you could cure any diabetic’s gender, age group, or lengrt of timw w/desesae, you would do so. You would not be asking what group we prefer. Cure any one segment, and the remainder will quickly follow.
    Ladies and gentleman, does,”Send money”, not sound familiar to one and all.
    I have been reading and hearing this for will over 50 years. So far, diabetics have a better glucose testing system, smaller syringes, but used more frequently, better insulins, and possible better overall control. The insulin pump is easier but not much better. The Continuous Glucose Monitor (CGM)will be an outstanding improvement for instead of 4-8 testing moments in a day your glucose is monitored every 5 mins. 24/7.
    An alarm sounds at the start of highs and lows (your setting)which gives u time to correct & avoid. Insurance companies, and especially Medicre don’t cover expense. This is where your money should be spent.

    Posted by muirland |
  6. Interested in avoiding dangerous highs and lows, this tech. is available, but we must get Insurance to cover expense of the Continous Glucose Monitor (CGM), as they already do with the insulin pump.
    The CGM CAN DO FAR, FAR, MORE GOOD, AS YOUR ENDO. WILL AFFIRM.

    Posted by muirland |
  7. Medical waivers are not worth the paper they are written on. People sign these for whatever reason they are admitted to the hospital, always.
    WHY??
    Their legal staff has shown there are 18% fewer civil cases with this signed document.
    When you start a civil suit this waiver is immediately dismissed because your forced to sign in order to be admitted. This makes waiver non-binding.
    Been there.

    Posted by muirland |
  8. Some of these comments seem to NOT realize that after a period of Type 1 diabetes your Beta Cells are GONE. These trials are aimed at arresting the destruction of remaining beta Cells shortly after diagnosis. Good luck to these trials. We long-term Type 1’s will have to wait for some way to restore our Beta Cells.

    Posted by BillR |
  9. I have type 1 and use a Medtronic pump.

    I am interested in buying, at my expense, a Continuous Glucose Monitor and would like feed back from users.

    Can I reduce some finger sticks?

    Is it accurate?

    Any information would be grateful.

    Thank you.

    Posted by Ben B |
  10. I have had Type I Diabetes for 35 years. My A1c is not as low as those mentioned here and I have suffered from some diabetes-related complications. However, unlike many of those who have written, I am happy to see advances made in diabetes treatment (ANY treatment). If these advances mean someone else doesn’t have to go through what each of us has gone through, shouldn’t we all be happy for those who will benefit? I know I am! Just the thought of a young person going from the devastating diagnosis of Type I Diabetes to being told there may be a cure (a CURE, really, not strictly treatment, but a cure? wow, to my knowledge DM and a cure for anyone have never been linked together before now).

    So, how about a little more appreciation and a little less selfishness.

    Posted by Friz |
  11. In response to the latest article on clinical trials,i thought that patients with type 1 diabetes, who have had the disease for a long period of time, would benefit more, and possibly save
    themselves from the horrible effects of the disease. I would gladly volunter for any trial
    but i have had diabetes for 29 years. Where do i fit in?

    Posted by Lisa Young |
  12. I read these posts and feel lucky. I am 33 yrs old and have had IDDM type 1 for 18 years. Just last week I got my 4th pump from medtronic and this one came with the CGM System. Mine luckily was covered 100% by insurance. It has not decreased my finger sticks in fact just the opposite I now check my sugar 5-8 times a day. But I am checking at the right times now and can see the trends that my body has. As far as accuracy, it is ok but has been at times 20% off of the finger stick number all depends on how much insulin is running through your system at the time.

    Ben hope that helps some I’ll let you all know how it goes if you want.

    Posted by Jason M |
  13. For the person whining that type 2 diabetics should be involved in type 1 studies, get over it. Far and away the money and research is being poured into Type II now that fat aunt sally and rich old Joe have it. You have far more going on in type II because of who has it, leave the blameless type 1 diabetics alone.

    Posted by Clint |

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