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New Resource: Next Expected Milestone

Discussion in 'Research' started by joshualevy, Mar 28, 2011.

  1. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    I have the first draft of a new on-line resource for tracking research aimed at curing type-1 diabetes. It is not in a "polished" form as yet. I'm releasing it now partly because I think it will be very helpful, and partly so you can give me feedback on it.

    I call it the Next Expected Milestone page. It's permanent home is here:
    But I've included the important part below.

    My goal with this page is to make it easy, for each clinical trial, to see what research milestones are expected to be completed in the next month, season, year, etc. On the one hand, this page can serve as an TLOD ("too long over due") list of research that isn't reporting the expected results. On the other hand, it can tell you what announcements to especially look for in the next few months.

    In the table below, the the important column is the last one. It contains the next expected milestone the researchers should make. So "Jun-2011 III Results !" means that in June of 2011, that trial should release their results, and the ! means they have publicly said they will do this. "April-2012 II Started" means they will start a phase-II trial in April 2012, and so on. Red dates are long over due. Orange dates are slightly over due. and BoldGreen dates are coming up in the next few months. All the columns in the table, and all the abbreviations and acronyms, are described in a section below the table.

    [SIZE="2"]Name          Id/Developer           Notes            Date Last Milestone        Date Next Milestone
    Lisofylline   DiaKine                Inflam           May-2009 I Started         [COLOR="Red"]Dec-2009 I Complete[/COLOR]
    BCG           Faustman               Estab Comm       Jun-2010 I GotData         [COLOR="Red"]Oct-2010 I Results[/COLOR]
    Anakinra      NCT00645840            Inflam (Kineret) Jun-2010 I Completed       [COLOR="Red"]Dec-2010 I Results[/COLOR]
    Exsulin       Exsulin                Beta             Sep-2009 II Started        [COLOR="Red"]Nov-2010 II Complete[/COLOR]
    Atorvastatin  NCT00529191            (Lipitor)        Feb-2010 II Enrolled       [COLOR="DarkOrange"]Feb-2011 GotData[/COLOR]
    Etanercept    NCT00730392            (ENBREL)         Apr-2009 I Results         [COLOR="SeaGreen"]Apr-2011 II Start[/COLOR]
    GAD65*        NCT00723411 - EU                        Nov-2009 III Enrolled      [COLOR="SeaGreen"]Jun-2011 III Results![/COLOR]
    Dendritics    NCT00445913            Estab            Feb-2011 I Enrolled[*]     [COLOR="SeaGreen"]Jun-2011 Results[/COLOR]
    Liraglutide   Hvidovre Univ Hosp     Estab            Jan-2011 II Complete       Jul-2011 II Results
    AAT           Kamada                 Inflam           Mar-2011 I Paperwork       Aug-2011 I Starts
    Anakinra      AIDA                   Inflam (Kineret) Jan-2009 I Starts          Sep-2011 I Complete 
    BHT-3021      NCT00453375            Estab            Nov-2010 I Enrolled        Oct-2011 I Complete?
    Xoma 52       Xoma Corp              Estab Inflam     Jul-2010 II Enrolled       Oct-2011 II Results
    GAD65         NCT00751842 DIAPREVENT                  Nov-2010 III Enrolled     Oct-2011 III Complete 
    DiaPep227*    DIA-AID1 NCT00615264                    Sep-2009 III Enrolled      Dec-2011 III Complete
    Rituximab     Pescovitz at Indiana                    Dec-2009 II Publication?   Dec-2011 III Start?
    Cord Blood    Haller                                  Mar-2009 II Started        Mar-2012 II Complete?
    PROCHYMAL     Osiris                                  Jan-2010 II Enrolled       Apr-2012 II Results
    Pioglitazone  NCT00545857                             Oct-2009 I HalfEnrolled    Jun-2012 I Complete
    GCSF          NCT01102699            Estab            May-2010 I Started         Jun-2012 I Complete 
    IBC-VS01      NCT00057499 Orban                       Jun-2010 I Published       Jun-2012 II Start
    GAD65 [1]     NCT00837759            Estab            Jan-2011 II Enrolled       Oct-2012 II Complete 
    GAD           NCT00529399                             Apr-2010 II Enrolled       Dec-2012 II Complete 
    Sitagliptin   Garg                   Estab            Feb-2011 I Results         Feb-2013 II Start
    GCSF          Haller                                  Apr-2008 I Start           Apr-2013 I Complete
    ATG GCSF      Haller                 Estab            Apr-2010 I Started ?Aug    Apr-2013 I Complete
    AAT           NCT01319331            Estab Inflam     Mar-2011 I Started         Sep-2013 II Complete 
    Abatacept     Orban at Joslin                         Feb-2008 II Started        Sep-2013 Results
    Proleukin Rapamune  NCT00525889      Estab            Nov-2010 I Enrolled        Sep-2013 I Complete?
    NI-0401       NovImmune                               Aug-2010 II Started        Aug-2013 II Results ?
    Rituximab     NCT01280682                             July-2010 II Started       Dec-2013 II Completed
    DiaPep 277    DIA-AID2 NCT01103284                    May-2010 III Started       Mar-2014 III Complete
    AAT*          RETAIN-1 NCT01183468   Inflam           Oct-2010 II FirstDose      Nov-2014 II Complete
    Canakinumab   TrialNet               Inflam           Mar-2011 I Enrolled        Dec-2014 I Complete 
    ATG           START NCT00515099                       Aug-2007 II Started        June-2015 II Results
    Poly Tregs    Gitelman               Estab            Jan-2011 I Started         2016 I Results
    [1] Combo trial including GAD65, lansoprazole, and sitagliptin[/SIZE]
    Understanding The Table

    Each line is a separate clinical trial (so drugs/treatments with more than one trial active may have more than one line).

    The most common name of the drug or treatment. Only one is included. For drugs that have trade names and generic names, I usually use the generic name if there is space for it. A * means this is the leading (farthest along) clinical trial for this drug or treatment in type-1 diabetes, for treatments with many studies going on at the same time.

    Should be an identifying number or trial name, or both. However, I started out putting the name of the researcher here, and I'm only slowly replacing that with the US government's clinical trial number, or a similar number from another governmental organization. Developer is the organization creating the treatment or testing it. Only one is included.

    Here are the notations in this field:

    * Appr: Drug or treatment already approved in the US or EU or both.
    * Beta: Drug or treatment aimed at increasing beta cell mass or efficiency.
    * Comm: A commonly used drug, so widely prescribed or not prescription at all.
    * Estab: A trial on established (non-honeymoon) type-1 diabetics. Generally over 1 year.
    * Inflam: A drug or treatment based on preventing or lowering inflammation.
    * Prev: A trial aimed at preventing type-1, not curing it.
    * Treat: A drug aimed at treating type-1, not curing it.
    * (...): A trade name of the drug in the trial, these drugs are usually "Appr".

    Milestone Columns
    The last two columns in the table are both milestones, and are very similar. Here are the types of milestones listed in these columns:

    * Paperwork: Filed the paperwork required to start a trial. Usually either the clinical trial record, or the IND application, if in the USA.
    * Start: Started trying to enrolling patients in the trial. Recruitment has started.
    * First Dose: The first patient actually enrolled and dosed.
    * Enrolled: Finished enrolling patients in the trial. Trial is full.
    * Complete: The completion date from the clinical trial record.
    * GotData: Finished gathering data.
    * Results: Important results published in some form (paper, symposia, abstract,etc.)
    * Published: Important Results published in a peer reviewed journal.

    Also, these marks are used in both milestone columns:

    * "I", "II", and "III" refers to phases of clinical trials, and trials which the researchers consider phase-IV, are considered phase-II here.
    * A "?" means I need to recheck that date.
    * A "!" means the researcher or organization has publicly listed that date.

    Last Milestone
    This column contains the date and content of this research's last milestone.

    Next Milestone
    This column contains the date and content of this research's next expected milestone.

    Joshua Levy
    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.
    Blog: http://cureresearch4type1diabetes.blogspot.com
    To Get as Email Join here: http://groups.google.com/group/type-1-diabetes-clinical-trials-news
  2. Ali

    Ali Approved members

    Aug 1, 2006
    Looks good but some limited info on some drugs. For instance the lipitor trial notes give me zero information on what the trial is for. Ali
  3. DadCares

    DadCares Approved members

    Apr 19, 2006

    I love your organization of information. It makes it so much easier to track research efforts. How hard would it be to make these additions:

    1. Change "Notes" to "Category"
    2. Add new column "Strategy" or "Notes" - Example entries might include, "IL-17", "IL-21", "autoreactive T-cells", "dendritic cells" etc. - Something brief that distiguishes one autoimmune or inflammation strategy from another.
    Last edited: Mar 29, 2011
  4. ecure

    ecure Approved members

    Nov 13, 2010
    If you filter your list with the researches aim to reverse advanced stage diabetes type 1 and not just improve the glycemia , It would be very short list... could you make a list like that? thank you
  5. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    That's true. You can get more information on all of them here:
    (search for the right trial or use a tag)
    I will put in text to explain this, because it isn't clear right now.

    I felt it was very important that each entry fit on one line (on my blog). I'm right at that limit now. There are many more columns that could be useful, but that I don't have room for. This is my general answer to "DadCares" as well. I would like to put more detail on each entry, also. But I don't have space on the line.

    Joshua Levy
  6. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    You can do this yourself. Just grab all the lines that contain "Estab" on them. That is the note for "Established Diabetes", which is what you are looking for. There are about 12 in that group.

    As I move forward, the ones that are just to improve glysemic control, will be in a separate table, and marked "Treat" (for Treatment). But I'm still working on the separation.

    Joshua Levy
  7. ecure

    ecure Approved members

    Nov 13, 2010
    Estab is not necessary aims to reverse diabetes type 1 at advanced stage.
    I checked the researches with Estab on clinicaltrials.gov and all their descriptions state the objective is to improve gylcemia or something around this. I cannot find one with objective to reverse diabetes t1 at advanced stage on clinicaltrials.gov. except Dr Faustman.
  8. joshualevy

    joshualevy Approved members

    Dec 30, 2008
    I can provide information, but I can not get you to read something that you don't want to read. Here is the official title for the "ATG GCSF" (NCT01106157) trial which I have listed as "Estab".

    Reversing Type 1 Diabetes After it is Established

    You can't get any more blunt than that.
    If you didn't even read the title of the trial, there is nothing I can do about that.

    Interestingly, Dr. Faustman's research does NOT say that she is trying to "reverse diabetes t1 at advanced stage" as you put it. Instead, it says this: "This is the first step in trying to cure established type 1 diabetes." Note it is a "first step," not a complete anything.

    You really need to get your facts straight.

    Joshua Levy
  9. ecure

    ecure Approved members

    Nov 13, 2010

    If you check the exclusion criteria of Dr faustman :
    "?Fasting or stimulated (1 mg glucagon stimulation test) c-peptide > 0.2 pmol/mL"
    It shows clearly the research is for advanced stage diabetes type 1.

    Dr Faustman inclusion criterias are more wide open than the research NCT01106157.
    ?Must have stimulated C-peptide levels ≥ 0.1 pmol/ml (0.3ng/mL) when measured during a mixed meal tolerance test (MMTT), conducted at least 4 months from diagnosis of diabetes, and within 8 weeks of randomization
    ?Must have a diagnosis of T1D of greater than 4 months duration, with an upper limit of 2 years

    UPPER limit criteria.. and c-peptide minimum level...Dr Faustman has exclusion criteria for diabetes at too much onset stage and too high c-peptide level..

    Any other research to add joshua without criteria like NCT01106157.
  10. carbz

    carbz Banned

    Nov 27, 2009
    The only companies focused on completely reversing long term type 1 to my knowledge are :

    Dr Faustman
    LCT (which is not disease reversal but still a valid prospect treatment)
    Sernova corp (same as LCT)
    Cerco Medical (again same as LCT)
  11. Enddiabetes

    Enddiabetes Approved members

    Aug 19, 2010
    Hi Carbz. The ATG/GCSF trial seeks to do that as well. Just started recently. Both are approved drugs used for other purposes. Its referenced by Josh above.

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