This trial is giving two drugs (both of which are already in use) to people with type-1 diabetes in their honeymoon phase. The hope is that it will preserve some beta cell function. This study is not yet recruiting patients. They hope to recruit 54 patients and finish in April 2014. Sitagliptin is the generic name for Januvia, and Lansoprozole is the generic name for Prevacid.
A Little Discussion: I still don't understand why this is supposed to preserve beta cells.
When I blogged about the Sitagliptin only clinical trial, I said that I didn't understand why it might help type-1 diabetics; and I still don't. With this trial, I don't understand why adding a antacid like Lansoprozole would help type-1 diabetics, either. On the other hand, Januvia is available now for type-2 diabetes with a prescription, and Prevacid is available "over the counter" and as a generic. So if this pans out, you will be able to get this as an "off label" use without waiting for further FDA approvals.
For me, a far more interesting trial, which I have blogged about before, is being run by the NIH, and which uses Diamyd plus Sitagliptin and Lansoprozole. That one I understand: Diamyd stops the autoimmune attack by retraining it, and the other two drugs reverse beta cell damage or develop new beta cells. You can read about that study here:
and I think they have upped the enrollment to 7 since I wrote that blog entry. On the other hand, if this Sitagliptin and Lansoprozole only study lays a scientific foundation for more studies where they pair it with something to stop the autoimmune attack, that would be valuable.
News article: http://www.argusleader.com/article/20100811/NEWS/8110318/1001
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01155284
Other Phase-II trial of Sitagliptin: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials#SitagliptinbyGarg
Blogging on Sitagliptin: http://cureresearch4type1diabetes.blogspot.com/search/label/Sitagliptin
Wikipedia for Sitagliptin: http://en.wikipedia.org/wiki/Sitagliptin
Wikipedia for Lansoprazole: http://en.wikipedia.org/wiki/Lansoprazole
Delay in Trucco's Phase-I Trial
Trucco's clinical trial is one of the first ones that I ever followed in my "status" web page. That was years before I started my blog. I've never blogged on it, because there has never been news. Basically, they remove dentric cells, which are part of the immune system, treat those cells, and then put them back in the patient (the same patient where they came from). This trial only enrolls people who have had diabetes for more than five years, so honeymooners are excluded. It is a safety only study: they are not measuring any BG, A1C, insuline usage or C-peptide numbers. If it turns out safe, then they plan to start a honeymooner only study to see if it improves any of those things.
Now, finally, there is news. In June 2010, Trucco's group updated their clinical trials record as follows:
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||June 2011 (previously had been mid-2010)|
|Estimated Primary Completion Date:||December 2010 (previously had been mid-2009)|
Web status page: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials#TruccoatChildren%E2%80%99sHospitalofPittsburgh
Year old newspaper article: http://durangoherald.com/sections/Features/Health/2009/08/24/Experiment_seeks_way_to_head_off_Type_1_diabetes_found_in_children/
Scientific Overview: http://www.mcgowan.pitt.edu/news/images/Trucco_PediatricDiabetes_2008.pdf
(Includes a nice diagram on page 8, even if the rest is highly technical.)
One Possible Cure, but not yet in Clinical Trials.
Some researchers in India are working with a "release as needed" injected insulin. This is broadly similar to SmartInsulin. A single injection of this new insulin, called Supramolecular Insulin Assembly II (SIA-II) resulted in good blood glucose levels (which they call "physiologic glucose levels") for over 100 days in animals. I'm very much looking forward to what this does in people. But remember: drugs generally take 10+ years to go through human trials, and less than half of the drugs successful in animals ever go on to human trials. (Since this is an Insulin it might be slightly faster than 10 years, but not much.)
News report: http://www.dnaindia.com/india/report_india-develops-single-shot-insulin-for-diabetics_1409481
Another benefit of this drug, is that it puts pressure on the SmartInsulin developers. In turn the SmartInsulin developers put pressure on the SIA-II developers. I'm a firm believer that competition pushes both groups of developers to move faster, so I'm all for it. It sounds to me like both SmartInsulin and SIA-II are close to starting human trials, but SmartInsulin is closer.
Discussion: What is a Cure? Is this a Cure?
This drug (and also Smart Insulin) can start off an interesting parlor conversation about what is a cure? Are treatments like SmartInsulin or SIA-II cures? Obviously, each of us must make up their own mind about what is and is not a cure. But in my mind, a treatment that required one injection every 3 months, and no blood glucose checks, no dietary limitations (no counting carbs), with no long term side effects and a normal life expectancy. Personally, I would call that a cure, even though it requires an injection every 3 months, and even though you would have type-1 "on the inside". It would be a functional cure. Your opinion may differ.
News from Cerco Medical
I don't really cover Cerco Medical, because they have not yet started human trials for their "islet sheet", which is an encapsulated beta cell cure generally similar to LCT's Diabcell. However I know people are interested in it, and this is the most specific news I've heard about when they are hoping to start a clinical trial:
His [Scott R. King, president of Cerco Medical] company is planning to begin human testing in 2012 or 2013.This comes from a newspaper article, which is mostly about Artificial Pancreas work in Oregon: http://www.oregonlive.com/health/index.ssf/2010/08/putting_blood-sugar_control_on.html
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.