Thursday, February 5, 2009

Diamyd Starts Phase-II Trial Aimed at Established Type-1 Diabetics

Diamyd has announced NIDDK is starting a clinical trial to study a combination of their GAD65 immunesupressive together with two drugs designed to stimulate the body's own beta cell growth and insulin generation.

You can read the press release here:
http://www.diamyd.com/docs/PressClip.aspx?PageID=4&ClipID=486
the headline is:

DIAMYD® COMBINATION TRIAL AIMED AT REGENERATING INSULIN-PRODUCING CAPACITY IN ESTABLISHED TYPE 1 DIABETES GETS APPROVAL FROM FDA

Background
Diamyd's product is an immunesupressive that specifically targets GAD, which is one of the markers for type-1 diabetes. This treatment is currently in two large phase-III trials for honeymoon (recent onset) type-1 diabetics, one in the US and one in the EU. Data from phase-I and phase-II trials, also on honeymooners, show that treated patients use less insulin than untreated patients. Some quite a bit less, and some did not need to use insulin at all for short periods of time. So this is all good news for honeymoon diabetics.

This phase-II human trial takes the same basic treatment and combines it with drugs already approved for type-2 diabetics in an attempt to cure (or improve) non-honeymoon diabetics.

The Study that is Starting Now
They want to enroll 164 people, starting Feburary 2009.
There is no information on how long it will last, or when results will be available.
It is Randomized, Double-Blind, and Placebo Controlled.
One interesting wrinkle is that it is only open to honeymoon diabetics, even thought the treatment is clearly focused on non-honeymooners. I think this is because GAD65 has only been tested on honeymoon diabetics, and is not yet approved for the mass market, so limiting these tests to honeymooners only will speed things along (no extra safety testing for a new population). Anyway the press release makes clear that they are trying to regenerate the body's own ability to make new beta cells (and thus more insulin), and that it is designed for non-honeymooners.

Here is how Diamyd describes it:
This new Phase II study will be the first to combine regenerative agents and Diamyd®. The regenerative agents to be evaluated are lansoprazole and sitagliptin, which are both marketed drugs in the US. The study, to be led by Professor David Harlan at NIDDK, aims to enroll 82 adult patients. "We are excited to start this study to investigate if combining Diamyd® with potentially regenerative stimuli can meaningfully improve treatment of established type 1 diabetes", says Professor Harlan, chief of the Diabetes Branch at NIDDK and professor of medicine at the Uniformed Services University of the Health Sciences.

Notes: NIDDK is part of NIH: the National Institues of Health, part of the federal [USA] government. Also, I think the 82 people listed above is the number who will get the treatment. Another 82 will get placebos, for a total of 164.

You can read more about it at the US Government's Clinical Trials site: http://www.clinicaltrials.gov/ct2/show/NCT00837759

Why is this Important?
In my mind, this clinical trial is very important for two reasons:

First is the tactical reason: Because Diamyd's drug is already undergoing phase-III trials, it could be approved for general use (with a prescription) in 3 or 4 years. The other drugs used in this trial have been generally available for several years. So in just 3 or 4 years we will have results of this phase-II trial and general availability of all the drugs needed. So if this trial is successful, you could actually get the treatment as an "off label" use, if your doctor was willing to write the prescriptions.

Second is the strategic reason: There are several drugs in phase-III and phase-II clinical trials which are targeted at honeymoon type-1 diabetics and which work by stopping the immune attack and "saving" some insulin production. This trial is the first attempt that I know of to take a honeymoon only cure, and make it work on non-honeymooners. But if it works, the same idea could be applied to ToleRx's treatment, Andromedia's treatment, MacroGenic's treatment, Rituximab, Thymoglobulin, Abatacept, etc. That gives us all a lot more chances for a cure using treatments which are already well into the approval process.

Also, one of the controversies in type-1 cure research today is this: does the body naturally regenerate beta cells (and thus insulin production) or not? If the body does, then every honeymoon only cure will become a cure for everyone, if you just wait for the body to regrow it's own beta cells. However if the body does not, then those cures will only work for honeymooners. However, if this clinical trial is successful in finding a path that works with non-honeymooners, then the whole question of regeneration of beta cells is not important: if they naturally regenerate: great. If not, this experiment (if successful) shows how they can be regrown anyway. Type-1 can be cured in either case.

This is big news. This is good news.

20 comments:

danielle said...

Hi Joshua,

Interesting read your blog! I was at at talk last night at Leiden University Medical Center, where it was stated as a fact, that even in people who've had type 1 for 40-60 years, who then donate their body for science, they find 30% beta cells still residing in their pancreas, and further evidence that because the immunosystem slows down when you get older, the beta cells have still got duplication powers. It was also stated that testing in this study and others is done for strategic reasons, because effects are more easily proven in hoenymooners. If you go back to the first statement, we might all be honeymooners and then if the results are positive we might all be in for a good treatment in years to come.

Oh and I agree with what you think is a cure, although I would prefer not to see my doc so often as 4 times a year, even though he is an okay guy..... ;-) But I gladly would, if they could take away all the stabbing....

Take care,
Daniƫlle
type 1 since 1990

Carina said...

Hi Joshua I love the realism to your site. I have had type 1 for 10 yrs this year ( i got it after glandular fever when i was 34) and i must say my honeymoon is over.

I did astound many docs early on as I was using natural therapies when I was first diagnosed and took myself off the needle for 10 and a half months after being on 4 jabs a day.

I think part of the reason it left was i was using the cancer diet and eating lots of raw food. One of the reasons I think it came back was i then got cocky and started to party hard - not good for prolonged healing.

I am open to curing this disease anyway i can but there is something comforting in science - so well done.

Brendan

PinkyLee said...

Our son, 17, was diagnosed with T1 in mid December. His doctor immediately put him on Januvia. Within two weeks we saw his need for insulin drop dramatically and now two months later, he only takes 18 units of Lantus once a day and has normal BG while testing 8 to 10 times per day and eating an unrestricted diet of 3-6,000 calories a day (400-500 carbs). His doctor has tried to get him into clinic trials but he won't be 18 until July. I have been searching everywhere for more information on this treatment. His doctor is not an endocrinologist but a sports' medicine doctor. He said he has been in contact with endocrinologists who are on the cutting edge of diabetes research. Is this study you're talking about anything like this?

PinkyLee said...

Found the Januvia study through your links - thanks so much!

http://www.clinicaltrials.gov/ct2/show/NCT00978796?intr=%22Sitagliptin%22&rank=16

Anonymous said...

My daughter was diagnosed with T1 in December 09,at the age of 12. When we came home from the hospital she was on 15 units of Lantus am & pm, plus Novolog before meals. After a week we started lowering her doses, she needed less and less each day, and after a month we took her off Novolog, and sticked to Lantus once a day, morning only. In mid February she was on 1o units of Lantus. We were told about Diamyd trial,timing was perfect, she was tested, turned out that she was eligible for the study, and she already recevied 2 shots ( of course we still don't know what group is she in, 1,2, or 3 and what is she receiving), but her results are great, she is now on 4 units on Lantus in the morning. And her HA1C went down to 5.2! Her endocrinologist was amazed with the results. I asked him if he ever has this kind of results just with children being in honeymoon, and he answeed that he didn't. I forgot to mention is that my daughter is the first patient for Diamyd study in this hospital. Nobody knows yet if this is just great honeymoon period, or it's honeymoon and Dimayd combined, but we're grateful for every day that she still has great BG readings, with these low doses of Lantus, and waiting for our 3d visit for Diamyd shot.

Anonymous said...

We also contacted a nutritionist who ordered blood work and after going over those results she modified our daughter's diet with having pure protein for breakfast, and then carbs and protein at lunch ( sandwich) and dinner with protein and carbs.She also recommended some natural supplements that our daughter is taking twice a day. We are very pleased with the diet regime, because my husband and I definitely disagree with endocrinologists who kept telling us that she can still eat everything. She wakes up every morning around 100- 130, during the day sometimes it goes up to 140-200, depending what she eats, and then it adjusts back to around 100s. I don't know if your Dr. told you that teens in puberty tend to get higher numbers over night, because of the hormonal changes that usually kick in during sleep. So don't be too worried if your son has higher readings during night, or when he wakes up in the morning.

Anonymous said...

We started with a nutritionist but they had very little knowledge about how an athlete's body (he practices 2-4 hours per day) responds to diabetes so his doctor said he'd handle it. Because of the huge caloric need his doctor put him on an unrestricted diet. He is 75-90 in the morning; drops to 60-70 mid-morning no matter what he eats for breakfast then is usually around 120 right after school and before practice or a game even when he carb loads. After exercise, he's in the 70's or 80's. His high is in the evening and has consistently been below 200 even when he eats huge amounts of carbs in the evening - usually its 140-150 which is normal. For awhile I was waking him up at 2:00 a.m. to make sure his BG wasn't dropping too low but since we've decreased his Lantus we haven't had that problem. I'm eagerly waiting for the results from the University of Colorado where just Januvia was given to see its effects on BG.

Anonymous said...

How many times did your son take Januvia? Is it in form of a vaccine or pill? Did they talk to you about Diamyd?

Anonymous said...

He takes 100 units of Januvia once a day in a pill at the same time he takes 12 units of Lantus. No, they did not talk to us about Diamyd.

He took his BG five times yesterday and it ranged from 98 to 137 while consuming about 520 carbs for the day. I believe that if he could limit carbs (which would mean he would also have to cut his exercise and training program), he would not have to take any Lantus. His doctor is amazed at what is going on and wonders if it's a combination of the drug and the extreme exercise.

Anonymous said...

great, whatever it is, let it work and keep BG in control. Our daughter is in a double blind study, that 's what Diamyd is, so we won't know till fall 2011 if she received the drug or placebo. She plays softball now, which is not such a strenuous activity, during basketball season she had much more exercise than now. She also eats everything, just skips carbs for breakfast,all that with 4 units of Lantus in the morning. Our endo said that he wouldn't stop Lantus totally,since you don't want to overwork those cells that are still functioning. So she is still functioning great with this amount of Lantus. Last night at 9:30 pm , when she came home from practice, she was hungry. BG was 120, I gave her little pasta salad with veggies and cheese, and this morning she woke up with 112. As I said, whatever it is, we're just praying for every x day that we have that is good, and really having hope that soon they'll find the cure, or at least medication that will keep them at this level at which they are now. Good Luck to your son and you!

Anonymous said...

Our son's doctor dropped him down to 6 units of Lantus as of today so we'll see how this works when he goes back the end of this month for his A1C check. Right now we're getting BG readings better than normal. He's under a lot of pressure right now with sports which I'm sure supresses the glucose levels.

Good luck with your daughter! Maybe they are finally on their way to finding a cure for this awful disease and we're the pioneers.

Anonymous said...

This is a question for the Anonymous mom of the newly diagnosed (December 09) daughter in the Diamyd study.

Is she currently on Lantus only? Does she inject any Novilog before eating?

Also, which hospital did you enroll in the Diamyd Study?

What are the potential side effects of Diamyd? Has your daughter had any?

Anonymous said...

Hi, my daughter is still on 4 units of Lantus in the morning, no Novolog at all since early Feb 2010. At that time she was on 12 units of Lantus, and as of then they kept lowering it, after I sent them her latest readings every month, and here we are now on 4 units of Lantus. We are enrolled in the study at Hackensack University Hospital, in New Jersey. Our daughter had 3 shots of the drug or placebo, (we don't know yet of course what group is she in) and had absolutely no side effects. We also signed up for Diaprevent study, and tested our younger daughter for antibodies, just got results that she is negative. We'll take her again next year, and so on.

Anonymous said...

to the anonymous mom that her son is down to 6 units of Lantus, great news, hope he is still doing well, and has good HA1C. You're right, I hope the same, and have lots of faith that soon they'll find a cure, and our children can be spared of complications that this disease can trigger.

Anonymous said...

His last A1c, one month ago on 6-28, dropped from 5.9 to 5.6 with the 6 units of Lantus and no fast-acting insulin. His daily BG numbers are even better than before. He continues on the Januvia. Still trying to get him to gain back his ten pounds but he is just so active! His doctor talked about taking him off Lantus in September if these daily BG and A1c numbers hold up.

Anonymous said...

to the anonymous that her son is on Januvia: how is your son doing? I took my daughter for check up 2 days ago, A1C was 5.7, they didn't change anything, she is still on 4 units of Lantus in AM, and thank God functioning with that excellent throughout 24 hours. Once school started , and she got back in the routine we saw some lows in the morning hours, but nothing that dramataic, no shaking,no symptoms. Doctors and nurses are still asking themselves, so are we, is it Diamyd that 's giving her these great results, but we won't know for couple more years at least. She is scheduled for her last Dimayd shot in early December.

Anonymous said...

On his last checkup, he was a 5.8 and they dropped his Lantus to 4 but put him on Janumet (Januvia & Metformin). We have to go back in 8 weeks to see if he can come off the Lantus totally and just take Janumet twice a day. No lows, no highs - just has to watch how many evening carbs. He went to a football carb-loading evening meal and ate 380 carbs at that meal - went up to 170. Took 2 units of Humalog when he got home and went back to 110 within an hour. Doctor is amazed at the results. Hopefully this will buy him enough time to get through college starting next year and in the meantime some of these clinic results will be published.

Anonymous said...

To mom whose son is on Januvia :
My daughter received her last shot in Diamyd Trial last Thursday. Just got her results faxed over to me, her HA1C is 5.5. Now we wait for the European results to come out sometimes in spring of 2011. US clinical trial results won't be available for another 2 years probably. She will have 3 more visits, as part of the trial, but no more injections, just glucose tolerance test. Hope your son is doing well.

Anonymous said...

It was a year ago last Sunday that he was diagnosed. Last A1c three weeks ago was 6.0 with 4 units of Lantus daily and Janumet pill twice a day. Still eats whatever he wants whenever he wants but if really high nighttime carb consumption (300-400), he may take 2 or 3 units of humalog before he goes to bed. If he doesn't, his GB will be 102-108 in the morning instead of the usual 95-100. HOPEFULLY your daughter and our son are on the cutting edge of diabetes treatment OR maybe they're just one of those lucky diabetics who still have working BETA cells. I read an article on the JDRF site about "Medalists", people who have had T1 for 50 or more years and have no side effects and have had to take very little insulin over the years. Eight of them donated their body to science upon their death and all eight had working BETA cells.

Anonymous said...

Our daughter was also diagnosed a year ago, to be precise Dec. 21st (all of us will never forget that day...). Very thankful for a good year that she had, hoping for many many more like this. Our daughter also eats whatever she wants, even if she went a little high we didn't give her any Novolog at all, and she wakes up in the morning around 100 to 115. Wishing you a nice holiday, and happy new year with more great results for your son.I read the same article, about people that donated their bodies to science, and that all of them still had some beta cell working.