- The best news is a cure, or a measurable improvement in BG, A1C, or insulin used.
- The bigger the drop (in BG, A1C, or insulin used) and the more people helped, the better.
- Results for non-honeymoon diabetics are better than the same results for honeymooners.
- Results from later phase trials are better than results from earlier phase trials.
The "Big 5"
LCT finishes a phase-I trial, and shows some results
This news had it all: shows improvements for type-1 diabetics, works for people who have had diabetes for a long time, and marks the end of a clinical trial, with data we can see. Insulin usage dropped 24%, and almost everyone's A1C number went down. One person was cured (used no insulin at all) for a period of months.
Hope for next year: The start of a bigger trial and to see longer term data from this trial. Publication in a peer reviewed journal would be nice, too!
More data here: http://cureresearch4type1diabetes.blogspot.com/search/label/LCT
and here: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#LivingCellTechnologiesDiabecell
Burt Publishes 3+ year follow up data for their phase-I trials
This is the most amazing results seen yet: more than half of the patients where completely and permanently cured (low BG, A1C, and no more insulin needed). Some for over 3 years! Safety concerns linger, and it was honeymoon only.
Hope for next year: Start a phase-II trial for this, or better understand the safety issues.
More data is here: http://cureresearch4type1diabetes.blogspot.com/search/label/Burt
and here: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#UniversityofSaoPauloBurt
Diamyd starts two large phase-III trials
These guys are the closest to mass marketing a type-1 cure for some people. Their treatment shows improvements (lower BG, A1C and insulin usage) for many people, and might cure some people. It has only been tested on honeymooners, but once it is approved for general use, anyone will be able to try it. Their phase-II trails suggested that Diamyd use doubled the amount of surviving insulin producing beta cells. This means they require less insulin, and are very likely to have far fewer complicatoins in later life.
Hope for next year: See some intermediate results from this phase-III trial, or test it on non-honeymooners, or both!
More data is here: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#DiamydDiamydTorGAD65
and here: http://diamyd.blogspot.com/
ToleRx starts a phase-III trial
These guys are also making steady progress on a treatment that may cure some people and improve the health of many more. It has been shown to lower BG, A1C, and insulin requirements, but has only been tested on honeymooners. People treated in phase-II trails required significantly less insulin even after 18 months, compared with untreated people. (Although they did not have a big milestone this year, MicroGenics is testing a similar CD3 based cure, and is only a half step behind ToleRx.)
Hope for next year: Maybe finish this phase-III trial, or test it on non-honeymooners, or both!
More data is here: http://cureresearch4type1diabetes.blogspot.com/search/label/tolerx
and here: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#TolerrxTRX4orChAglyCD3
Gitelman and Osiris both started phase-II trails.
These are different immunology based cures, which are both at very similar point in their development. They are both being tested on honeymoon diabetics. Gitelman's research is based on previous phase-I research aimed a curing type-1 diabetes. The Osiris treatment has been tested in the past on several other immunological diseases, but this is the first time it has been tested as a cure for type-1 diabetes.
Hope for next year: probably nothing, but in 2010 good results from both!
More data is here: http://cureresearch4type1diabetes.blogspot.com/search/label/Gitelman http://cureresearch4type1diabetes.blogspot.com/search/label/Osiris
and here: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#NIAID/ITNGitelmanThymoglobulin/ATG http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#OsirisTherapeuticsPROCHYMAL
While the above paragraphs describe some specific research milestones of 2008, there are also more general good news out there. For example, I've been covering human trials aimed at curing type-1 diabetes for several years now, and every year I do it, there are more and more trials to keep track of. This year, for example, is the first year that there has been more than 1 phase-III clinical trial active. There were three of them at the end of the year. Will they all pan out? Probably not, but more trials means a bigger chance of one success. And we only need one success.
I'm also very intrigued by the new findings this year, about the importance of inflammation as a possible causative factor in type-1 diabetes. Although none of this research has yet led to clinical trials, it is clearly something new and different. As it is only a year old as a research direction, there is still lots of time for it to grow into something useful. Watch these guys: