Saturday, November 14, 2015
Research In The News (November)
MK-2640 ("Smart Insulin") Completes Enrollment Collection of a Phase-I Clinical Trial And Then Adds a New Part
MK-2640 is the Merck identifier for what we all know as Smart Insulin. It is the only "self dosing" insulin currently in human trials. The idea behind this drug is that you could inject it (maybe twice a day, maybe once a day, maybe once a week), and then it would release insulin if your BG numbers were high, and not if they were low. It is sort of a chemical artificial pancreas.
Because there is no data from human testing (nor have I seen any animal data), there is no way for me to know if MK-2640 is going to turn into a "lantus killer" (i.e. a great basal insulin), or if it is going to turn into something much closer to an artificial pancreas. For example, something you take once a week and not count carbs or otherwise worry about type-1 diabetes.
The First News
On 29-June-2015 Merck updated the clinical trial record to show that they were no longer recruiting people for this trial. Since this trial collects data for 37 days, that tells me that they finished in August. However, a different part of the record suggests they might have finished collecting data even earlier. Yet another part of the record was updated to show an "Estimated Study Completion Date" of October 2015. So that was all good news, and I was looking forward to them publishing results.
The Second News
Then (in September) they added a third part to what had previously been a two part clinical trial. Part three seems to be a continuation of part two (meaning they are testing in type-1 diabetics and are comparing MK-2640 to regular insulin. They are now recruiting again (presumably for part three), and have pushed out the completion date to early 2016. Part three will add 16 people to the test (from 58 to 74), but the testing looks pretty similar to part two.
A (Very Little) Discussion
Most of this clinical trial involves giving people MK-2640 (different groups of people getting three different doses), and then dripping sugar into them for 9 hours (7 hours in part three) and seeing what happens. The sugar is an IV drip ("intravenous infusion"), not eaten in a meal. In this case "what happens" means things like: side effects, BG levels, how quickly the body "clears" the drug out of the system, etc.
For me, the most important data will be how quickly MK-2640 lowers BG levels when sugar first starts hitting the bloodstream. If it lowers BG levels quickly, that means that it will work for meals (and is more of an AP replacement). However if it is slow to lower BG levels, that implies that it is more of a Basal insulin, and might replace Lantus/Levemir in the market, but not replace pumps/APs.
However, as I am an optimist, I will not forget that IV sugar is much faster acting than carbs eaten in a meal, so even if the results are so-so for IV sugar, I would expect better results from a real meal. Of course, it could turn out exactly the opposite: the slower sugar absorption might result in slower MK-2640 reaction times. I guess we'll have to wait for the first "real world food" tests. I only hope it gets that far.
I interpret adding the new part three section to be all good news. They added that after they had run the first two parts, and I don't think they would do more testing if the first parts did not look good. (A pessimist might say that if part two was not good, they were hoping to save the trial with data from the new part. However, I am an optimist so I think if part two was not good they would have just stopped, and since they pushed ahead, that is good news.)
Similarly, part two followed people for 9 hours, but part three only followed them for 7 hours. Is that good news, because it means that Smart Insulin reacted quickly? Or is it bad news because, Smart Insulin lost effectiveness after that? There is no way to tell, until they publish.
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02269735
MultiPepT1De (Multi Peptide Vaccine) Starts A Phase I Study
This is a follow on study to one of the very first clinical trials I ever followed:
That older trial injected a peptide (part of an insulin molecule) in the hopes that the immune system would learn not to auto-attack. This new study injects a mix of peptides to provide a broader education to the immune system. The basic idea is like injecting peanut proteins to teach the immune system not to be allergic to peanuts.
The study will enroll 24 adults, within four years of diagnosis. There is no information available on number of injections, duration of the study, primary or secondary end points. They are recruiting in London, England. Contact information is: Ms Rhanya Chaabane, Tel: 02071888472 Ext: 81932,
Note: This trial is registered with the United Kingdom's clinical trial registry which contains a lot less information than the United States clinical trial registry. It is also registered with the European Union clinical trial registry, but they don't publish records for phase-I trials at all. Therefore, I have a lot less information about this trial than other trials, which is why they are not getting a blog posting of their own.
Trial web site: http://www.multipeptide.co.uk/
Magazine article: http://www.multipeptide.co.uk/pdf/jdrf_article_on_multipeptide.pdf
Clinicial Trial Record: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=19114
Stop Following Gevokizumab (Xoma 052)
I've decided to stop following the drug Gevokizumab (which started it's research life as Xoma 052). You can see my previous coverage here:
The last news I had related to this drug in type-1 diabetes was that it started a Phase-II clinical trial in 2009. The clinical trial record was updated to "Completed" in 2014, but there is no listing for published results. I have searched for any results, but can find none, so I'm going to assume that the phase-II trial was a failure. (It was run by a commercial company, so there is no reason for them to publish the results, if the trial failed.)
Since that time, Xoma, the company developing Gevokizumab, has published clinical trial results for both type-2 diabetes and Behçet's disease uveitis (both failed their primary end point).
Based on all this, I'm going to remove Gevokizumab (Xoma 052) from the list of possible cures of type-1 diabetes that I follow.
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.