New life and Retain Trial

Hey everyone I was recently diagnosed in early December of 2010 kinda needed some space to vent and just put life out there. This came just in time for my finals for college at CU Boulder. During finals I ended up screening for the defend 2 trial. During the screening at the Barbara Davis center I was shown other trials they had running at the same time and trials they would hopefully be starting soon. This is where I learned about the Retain trials by the immune tolerance network. It’s an open label dosing trial for alpha-1 antitrypsan (AAT) in early onset t1 patients. I went with this trial because I knew I would be getting the drug and there is a track record of safety (AAT) since the 80’s with no adverse side affects. After deciding on this trial we learned that it was delayed at the Barbara Davis center possible beyond the 90 day from dx deadline so we had to find another center. Unfortunately at the time they were all east coast with all being north in blizzard prone areas (bad for flying) except Emory at Atlanta. Before beginning of second semester of school I flew to Atlanta to go to Emory University to get screened. With my luck this was also the day of the blizzard so the hospital was not even open. Practically snowed in we managed to get a meeting with the lead dr. of the trail who was able to find one assisting trial physician to come in the next day. So basically I ended up screening for the trial in the deserted Emory hospital. After getting screened it was days till we could leave and get back home. I finally learned I was accepted and was to start treatment on 1-31-11, the day before my 20th b-day. I also leaned I would need to be there weekly for infusions for 6 weeks each in two dosing periods and in the begging and end of each of the 2 dosing periods there for and entire week. Needless to say I ended up dropping all my classes at school and enrolling in online classes (not my idea of a good thing). I began the trial and got my first infusion on 1-31-11. at which time I also found out I was the very first patient to start this trial, I guess pretty cool but rather be first in other things but ill take it. Then spent the next week including my birthday in the strange city of Atlanta in a hotel room making the mundane daily pilgrimage to give blood at Emory. I received another dosing on the tail end of that trip. Flew back the next Sunday, got infused again Monday, came home and tomorrow I fly back again to be treated Monday for my 4th infusion. And this cycle repeats until the sixth dose then I stay for a week to give blood daily. Get a 3-week break and start the whole cycle over again. For a grand total of roughly 40 days ill be in Atlanta for this trial during the dosing then of course the after visits I haven’t event wanted to glance at yet. The real kicker to this is the bulk of the days are in the week long blood study periods where I literally spend less than 5 min in the hospital to give a vial of blood which Emory sends off to the main trial lab in a different state. This fact is very frustrating because it makes the trial so much more demanding for as far as I can see it a senseless reason. Overall it just seams like I should be able to give the blood at the Barbara Davis center especially because they should be starting the trial sometime in the near future just not in that first 90-day window I needed.

So that’s where my life is now, about six months ago I pretty much was just in constant party mode. One of the downsides of going to the fine institute of the University of Colorado is its pretty easy to have a really good time partying. This naturally involves a good amount of drinking. The social scene I found myself in is consequently mainly people that go out and party and drink on the weekends and take care of school the rest of the week. While this worked out great then, not so much now. I find myself sitting home alone on the weekends now working as late as I can at my shop because it’s not fun to be that sober person in a room full of drunks. People look a little different from the other side. My life is completely a–backwards of what it used to be not 3 months ago. I feel like im still getting used to the whole thing but at the same time I don’t even feel this is real yet. The words - diabetes and me - don’t connect in my head, it all almost seams like ill just wake up from this really long bad dream.

I’m sorry about your diagnosis, I can imagine it is very hard being a college student and not feeling like you can participate in the whole experience like you are used to. You mention the defend study but it sounds like you did something else. Did you take otelixizumab? My 12 year old did the Defend-2 Study in Dec. BTW, I lived in Boulder back in the 80’s. :slight_smile:

Yea its been a bit frustrating at times to say the least but Boulders an awesome place, was born here and had to move back for school. You are correct though i did not take the otelixzumab i just did the screening for it (mmt, blood work, cgm) i opted for a new trial that came out called the retain trial that is testing alpha-1 antitrypsan (AAT). The drug is actually called aralast np and they use it for people who have a deficiency as it is a naturally occurring amino acid that is believed to have impaired function in people with t1. It is a anti inflammatory and keeps tissues from breaking down ie: the pancreas in our case. So its the same idea as the defend trial as far as stopping the progression of the diesease. The main difference is AAT takes the anti inflammatory pathway at protecting the pancreas and the otelixzumab takes the immune response method of protecting the pancreas. Overall i like the fact that it had been used in humans for around 30 years and that it was open label so i knew i would get the drug. hope all is well with your son and he got the drug.

Good luck on your trial! My daughter is in Defend-2 right now. I couldn’t figure out the traveling for any other studies I saw & we have such a short window to get signed up & get started, this one seemed like a good option for us. You have gone through so many sudden changes that I hope you can sit back and get a little perspective. It’s definitely life-changing to get the T1 diagnosis, but you need to go on with your life plans and maybe get your party on with Diet Coke and an occassional beer? Carb-free beer? Has that been invented? Rolling Rock Light. It tastes like nothing, so it must be ok for diabetics :slight_smile:

Life is going, im in the middle of dosing periods now so a little break from the trial which has been nice. I really think I underestimated how much of my life this would consume. I spent 27 of 50 days in Atlanta during the first dosing schedule which is a long time to be away from home and regular life. The second dosing schedule is also slightly longer so a little more demanding. Also trying to get the blood test done in Colorado was a complete waste of time and only added to the frustration. The people at Emory are great and have done all they can to help but ITN denies every request i have. I can understand that their are concerns with accuracy and how there are concerns with FDA and such. However they said they “cannot change anything just for CONVENIENCE”, yes they used the word convenience. Sorry but i don’t look at saving thousands of dollars and days and days of my life as a convenience. I honestly feel completely disrespected and if my contribution to the community and trial is undervalued by this comment. I cant help but think about that word as a prepare to make plane ticket reservations for 9 weeks in a row and all that Im going to have to give up and all that its costing my family monetarily. Just feels like their is a major disconnect form the patient to the trial heads in my opinion. As far as regular life, still havent had a chance to figure out what thats like cause ive been so busy with said trial. But my a1c is a 4.9 so things look good but I can tell you my stress is higher than its ever been and that’s not good. Just want this to be over so i can finally start learning to live regular life with diabetes.

Also to add though I am a unique situation as far as trials go with traveling and such so dont let my experience discourage you. Still feel I have a great opportunity just wish things could be different.

most of this frustration pertains to the fact that most of the study days were not on the consent form. There was no pk’s in the consent or there was only 2 on the form so there was 28 - 15 days not on, a good bulk of the study, I did not sign on for. This is also the times that really kill me. I dread these weeks. The short weekly ones not so bad. So to say i signed up for its somewhat true. Basically I knew about the traveling weekly visits but it has progressed into much more. Also I was told by the Denver and Atlanta trial heads that accommodation of traveling patients is not unheard of especially since their is a center ITN works with that is in the area I live in. Also if you know about pk’s its a simple vial of blood they take and mail to their lab. There is a list of reasons that make sense in the bureaucracy we live in but none that make sense to me. Their is nothing really stopping the empty labeled blood vials being sent out to the Denver center and overnight mailed when filed by a RN just like they do at Emory but protocol that frankly I could care less for because it affects myself greatly but hey it is what it is. Overall if I want the aat I have do this and I want the aat so that’s what im doing. Also I know the trials are hard for everyone but the dimension of being away, missing a semesters of school (may have in Denver anyway but still frustrating for me), flying weekly and knowing the financial drain does make it considerably more difficult.

But to answer your question yes I am on the study drug, the one huge benefit of this trial vs the defend 2 trial i screened for they were doing in Denver but was blinded which and was messing with t-cells which caused me some concern. So I looked into Retain and signed up. I am excited about the 4.9 a1c but i also had a 7.3 a1c around the time I started or slightly before I started the study drug and that a1c I was told would be high because it was still not 120 days out from dx and i had some mixed meal tolerance test and such. So I really don’t exactly know how much the study drug is helping or its my control or what it its. Also I wonder how much it helps because im on the low dosage (half of what ill be starting on the next dosage cycle) Basically trying really really hard not to get my hopes because it looks so good so I may come off a little cynical. Also confused as to what’s doing what because I don’t feel like im working hard at control but also wasn’t before the trial and had good numbers then too. Also not to say I don’t get lows and some pretty bad ones but its cause I go to long without eating. But I never run highs, I think ive corrected only twice. Sometimes I eat 30-40 cabs with no fast acting insulin if im sitting at around 70 and often eat 20 without thinking about it and will still end up low hours later from my long acting so I think that’s pretty unique for a diabetic. I have a very low overall insulin requirement with 15 of Lantus a day and anywhere from 0 to 8 fast acting depending on what all I eat.

As far as your sister goes you should look into a trial omni that is also studying aralast np brand AAT but there are studying in patients 100 days to 5 years out from dx. I know it was at Barbera Davis in Denver but do not know if its anywhere else but your sister may qualify. I know she was in another trial so their may be conflict but worth a shot. But at least look up the results if anything ( I have heard they are good). If you try to find a doctor who will prescribe aat you might want to go ahead and order a home test kit for aat deficiency because if she does have a deficiency or something she may be able to receive it with less hassle. Hope she can find someway to give it a chance as it is very low risk (from what I know) ,has long term safety record and caused me no side affects. Will try to keep updated

Hey Dudely… I am a Type 1 living here in Atlanta and recently read our blog. Was diagnosed at the age of 6, now 30, and went through college as a diabetic. Also have a good friend that was diagnosed while he was in college, Nate Dever, that just competed and won 1st place in a Natural Bodybuilding contest here in Atlanta… If you’d like to get up while you’re here in ATL… let me know…… or look for me on Facebook (Dan Thrailkill)… hope all is cool… :slight_smile:

Been super busy but thought i would check back in here. Im still in the trial, sticking it out. It has been tough but now that the end is near it is getting much easier. I go in for my last dosing schedule this next week then 3 more follow up visits and im DONE!!!

More importantly are the results i have been experiencing. During the wash out period i noticed my blood sugars were consistently dropping super low and i would be munching sugar tabs all day. So i decided to start dropping my long acting inuslin dose until i got no more massive day time lows. Eventually i found myself taking no long acting and just my short acting to match my carb ratio. Now im even forgoing my short acting for meals with 40 carbs or less. So basically im taking zero insulin right now. This past week i took only 4 units of apidra in a 5 day period total with my bs topping out at 180 and remaining in the 120 -150 area after most meals. Im also waking up with bs of 90-110 without insulin. Im really truly hopeful that this trail has some play in this effects but im also aware that this could also be from a really strong honey moon. Also the trial director said another patient in the trial has also dropped insulin requirements and lowered their a1c. So for now im very hopeful but trying not to get too hopeful. Anyways i basically have been taking minimal short acting insulin with no long acting for 5 weeks now and i feel great! my bs has been undercontrol, the whole time with only a few 200 reading in that period of time. I get my a1c checked next week so that should give me a good idea just how good ive been doing with the significant drop in insulin. will let you all know what happens!