You can read the press release here:
the headline is:
DIAMYD® COMBINATION TRIAL AIMED AT REGENERATING INSULIN-PRODUCING CAPACITY IN ESTABLISHED TYPE 1 DIABETES GETS APPROVAL FROM FDABackground
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.