This posting is a collection of small updates.
Verapamil's Phase-II? Trial Completes Enrollment
Verapamil is a drug which has been used in the US since 1982 for high blood pressure, migraines, and heart problems. It also lowers levels of a protein called TXNIP. The researchers running this trial believe this is important because they believe TXNIP kills beta cells as part of the onset of type-1 diabetes. So giving Verapamil should lower TXNIP which should improve beta cell survival, and stop type-1 diabetes. In addition TXNIP is known to lower inflammation, and that might have an effect on type-1 diabetes as well. TXNIP worked in mice trials.
The news here is that they have completed enrollment. There is good and bad news in that. The good news is we now know that the trial will finish in 2019, since they completed enrollment in Jan 2018 and need to gather data for a year. The bad news is that they only recruited 32 people; they were hoping for 52.
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT02372253
Vitamin D Didn't Impact The Honeymoon In A Phase-I Trial
Vitamin D has been a hot topic for the last few years, and there are several different clinical trials looking at it in three different contexts: Does low Vitamin D help trigger type-1? Does increasing Vitamin D help prevent type-1? And, does increasing Vitamin D to people who have type-1, help treat or cure it? All together, there are 15 completed trials, 6 recruiting, and 2 underway but not recruiting, and one not yet started. That is strong interest.
This trial was a phase-I, honeymoon trial of 36 people. Half got Vitamin D, and half got a placebo. The patients who got Vitamin D did do a little better (used less insulin during their honeymoon), but the effect was not statistically significant.
Press Release: http://www.nationwidechildrens.org/medical-professional-publications/vitamin-d-and-the-honeymoon-period-of-type-1-diabetes?contentid=146302
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT01724190
Diamyd and Vitamin D start a phase-II Trial (DIAGNODE-2)
This clinical trial will test a Diamyd injection and oral Vitamin D in honeymoon type-1 diabetes.
It is recruiting in several European countries: Czechia, Spain, and Sweden. See the clinical trial record for a list of exact sites, there are many in each country.
Clinical Trial Record: https://clinicaltrials.gov/ct2/show/NCT03345004
Discussion
You can read my previous blogging on Diamyd here:
https://cureresearch4type1diabetes.blogspot.com/search/label/Diamyd
Diamyd has been tested for over 10 years. All previous trials (which have completed) have been unsuccessful. There are currently two other Diamyd and Vitamin D trials underway. While I'm always hopeful that these tests will be successful, Diamyd's long history without success does not give me much to hope for with this trial.
How well can you predict the outcome of clinical trials? Not as well as you may think.
One of the guiding quotes of this blog is "Opinions are not important; but what is important is the reasoning behind them, the data and information they are built on, etc. In short: why a person has opinions is more important than the opinions themselves. And that includes my opinions. Especially "my opinions." This is a news article on researcher's ability to predict the outcome of studies in their field. I thought it was interesting reading:
https://www.statnews.com/2018/01/22/clinical-trials-forecasting-outcomes/
A Stock Market Opinion: Diabetes Clinical Trials to Watch
This is a finance/stock analysis of what's important in 2018:
https://www.gurufocus.com/news/622818/three-diabetes-clinical-trials-to-watch-in-2018
From my point of view, they are all type-2 focused (which makes sense from a market share point of view: type-2 is 90% of the market).
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
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.
4 comments:
Extremely useful blog, thx from Hungary:)
From your report on recent diabetes investment, the smart money is betting that no cure will be available in the foreseeable future so the profitable thing to do is to invest in minor advances slightly to improve control in type 2 diabetes, compensating by the failure to accomplish anything significant by the larger market for small improvements among type 2s. This reminds me of the FDA's so-called 'panic bulletin' of 2008, when they sent around a notice of their alarm that for the first time, the number of new drugs seeking patent protection had declined, and that most new drugs developed over the previous decade had just been minor variations of existing treatments, contrived mainly to circumvent patent protections rather than to bring anything new to the patient.
A lot has been written about the stagnation of medicine in recent decades, and we may be seeing the effect in diabetes research of the phenomenon described by the historian of science Derek Price in the 1970s, which is that sciences grow the way bacteria in a dish do, so that after their initial foundation they grow exponentially fast, but then they slow and stagnate as their size reaches equilibrium with the forces preventing further growth. In science, this limit is set by the inability of single minds to span wide expanses of knowledge in a large field of study, so that they cannot simultaneously develop a sufficiently broad and deep awareness of the discipline to triangulate their way to significant new insights. As a result, research proceeds only on the basis of what narrowly specialized individuals can see and understand, so progress grinds to a halt. Type 1 diabetes has seen the development of a lot of trinkets and toys over the last 20 years which many patients find more trouble than they're worth, but nothing curative. The trinkets and toys may themselves be symptoms of the backing up of progress, since the lack of forward motion encourages more concentration of effort on small things.
Oral insulin and oral GLP-1 would be both hugely beneficial for type 1 diabetics, Mr Levy.
I am one and trust me, if I could take pills instead of my ten daily injections my flesh would thank me. It's clear you don't have the disease yourself otherwise those meds would be more on your radar. They aren't cures but steps in the right direction. GLP-1 is extremely good for type 1s, not just type 2s. It cuts your insulin requirements by a large factor and stabilizes sugars tremendously. The day I started taking Victoza, overnight my sugar variance dropped by 50% and my average by two points.
I'm also taking Verapamil for high BP since 2015 but I don't think it's helped my sugars much. I look forward to the study results but am not optimistic.
My c-peptides have risen from undetectable to 0.47 ng / ml by taking GLP-1. It stimulates beta cell neogenesis, this has been proven in vitro and in vivo.
Any research involving GLP agonists should be taken very seriously by those who are interested in reducing the hardship of living with and managing type 1 diabetes. IMO
Well, I do have type 1 diabetes and I would agree with most other sufferers of this disease that it would make absolutely no difference to me whether I could take insulin orally or not. That the problem with diabetes is injections is a misperception imposed on us generally by people who don't have the disease, who don't realize that after a single week of being diabetic, almost everyone regards injections as an utterly trivial nuisance. But because of the misunderstandings of people who don't have the disease, huge amounts of precious research funds have been thrown away trying to develop inhalable insulin as though that would solve anything.
The real problem of diabetes is its complications, and whether inhaled, swallowed, or injected, insulin therapy will never solve that, since the complications arise from the unavoidable mismatch between any insulin delivery system and actual insulin requirements, the persisting autoimmune attack in diabetics which continues against the rest of the body after it destroys the pancreatic beta cells, and genetic influences inherited along with the cluster of genes associated with the propensity to develop type 1 diabetes, which themselves cause or promote various complications.
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