Diamyd has finished enrolling patients in their 300 person, phase-III European trial. Diamyd is a vaccine like treatment designed to train the body's immune system not to attack itself and is focused on GAD65, which is the most common antibody marker carried by people with type-1 diabetes. Several human trials have already completed, and several more are in process. This trial is newly diagnosed type-1 diabetics, only.
Why is finishing enrollment important? For a couple of reasons:
- Once a trial is fully enrolled, everyone knows when it will end, or at least when they will finish gathering the required data. So in a very real sense, we can see the end of the tunnel now. This trial lasts 15 months, so the last person who enrolls in Nov-2009 will finish with the protocol in Feb-2011.
- Phase-III is the last phase before marketing approval of a new drug, so these guys are now the treatment second closest to general availability. (DiaPep227 Phase-III fully enrolled a few months ago.)
Exsulin Update: Vague Results and Another Phase-II Trial Starting
This news is actually from the Summer, but I haven't blogged about it before, so here it is:
Here is the highlight of the results from their last batch of clinical trials:
In the T1DM study (SPIRIT 1), Arginine-stimulated C-peptide (AUC0-30) significantly increased from baseline in the 600 mg group (p = 0.0058 versus placebo)My translation: the treatment caused people to generate more of their own insulin in response to a meal, when given 600mg. There was a second group that got 300mg, but they did not see any benefit. The full paper includes more detail one what was seen, but it looked pretty small to me.
Of course, the good news, is that this clinical trial only took them a few months to run, so they could easily make improvements to their process, and try it again. And that is what they are going to do:
The new phase-II trial is already recruiting it's 30 participants and they are hoping to have results by Q2 2010. Because INGAP does not stay in a person's system for very long, in this trial they will give smaller doses three times a day (rather than larger doses once a day), and therefore hope to have better effects and fewer side effects. They have also changed the formulation to have less irritation at the injection site. In their previous study, 25% of the people who got the higher dose, dropped out of the trial because of "adverse effects" (often this irritation), so that is a problem they want to address.
Abstract of research of completed phase-II trail:
Clinical Trial record for new phase-II trial:
I want to particularly thank fellow BraveBuddy Ricardo Dolmetsch for providing a lot of of the information that I used to report results from the previous trial and for providing some useful insight. Also thanks to ChildrenWithDiabetes member Ellen for pointing out the second phase-II study.
Phase-II Results from DiaPep227
DiaPep227 entered phase-III trials before I started to track clinical trials, so I've never blogged about their Phase-II results. However, since they're phase-III was the first to be fully enrolled, I thought it might be interesting to look at their previous results. Here is the quote from their abstract:
At 18 months, stimulated C-peptide concentrations had fallen in the placebo group (p = 0.0005) but were maintained in the DiaPep277 group. The need for exogenous insulin was higher in the placebo group than in the DiaPep277 group. Mean HbA1c concentrations were similar in both groups. After extension of the study, patients continuing treatment with DiaPep277 and those switched from placebo to DiaPep277 manifested a trend towards a greater preservation of beta-cell function compared to patients maintained on or switched to placebo. The safety profile of DiaPep277 was similar between the treatment and placebo groups, and no drug-related adverse events occurred.When I look at that summary, the first thing that I notice is that there are no numbers in the results (except a p value, which isn't a result, its a measurement of a result). It talks about C-peptide and A1C numbers, but does not give them. For me that is a big red flag. Vague qualitative statements ("need for exogenous insulin was higher") don't give me confidence. I want to know how much more insulin? And I don't see that data here. Exsulin's abstract in the news item above had the same problem, and reading the whole paper just reinforced by belief that no numbers in the abstract does not bode well for the strength of the results.
The complete paper is pay-per-view, so I'm just working off the abstract.
Abstract of research:
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF news, views, policies or opinions.