We Are Writing To Inform You...

....that everything you ever thought about your disease is all an illusion and in your head.

Or, to be more accurate.."that you were randomized into the Placebo arm of the Protege study."

Gah.

The rashes.  Probably due to the Picc line.  The nausea, the mild fevers, the anxiety, the insulin needs changing...completely unrelated.  Every day my temp went up! (They checked me every 15 minutes after the infusion, for an hour.)  I guess it was just me hoping for an effect, or maybe I just have a higher body temp at that time of day. (I don't even know if that's a thing.)

It makes sense. then, why I thought the first infusion helped so much but the second one did nothing.  My insulin needs dropped due to standard honeymooning.  It also explains why they had people drop their Lantus from 28 to 6, and I never got anywhere near that benefit.  I thought it was because I started with a lower dose.

But the honeymooning for 2 years?  That was just....normal?  Placebo effect?  Luck?

The silver lining in this cloud of "I left my family for weeks at a time for nothing." is that if the drug turns out to be toxic, I'm good!  No, that's not actually a silver lining, because I do not wish drug toxicity on anyone.  The real silver lining is that now I may be eligible for another study in the future.  That is, assuming they study anybody that's not in the realm of newly diagnosed.

Now I'm even madder that they stopped the studies on the drug.  I have joined the ranks of diabetics who could have been helped by this drug but aren't going to be because drug companies suck.

I wonder what else is an illusion........

RESULTS! RESULTS!

Ok the results are in and published for the Protege study, the one in which I participated. Conclusions? "Further study is warranted." Okee-dokee then. Good to know.

Link to MacroGenics press release:

http://www.macrogenics.com/press_releases-298.html

Link to the article through the MacroGenics website:

http://www.macrogenics.com/publications-141.html

My guess is that I was placed in N=106, which was a 6 day full dose - even though I went up for 2 full 2 week sessions. The first dose gave me a terrible rash (want to see?) and made my hair curly - I loved it! - and lowered my dosage considerably. The second dose just made me insane, which, let's face it, could be a strong placebo effect. Although, I did get somewhat of a rash then, too, but not nearly as bad.

Here's the first rash - after a few days of healing. Yeah, it hurt.

I can't wait to find out what I got. I wonder how long before I know.

Silly pancreas, tricks for are.....NOBODY. STOP.

In the diabetic version of "everything went to hell until I called the doctor" my sugars have been wacky until I had to document them for my last trip to Utah for the study. And then, they decide to behave. Not only behave, but behave BEAUTIFULLY.

91. 87. 109. etc, etc. (The highest I saw during the 3 day diary period was 126. OOOOH SOOOO HIGH!!!!) (Not really).

And so they looked at my sugars and couldn't tell me what to do to adjust, because obviously, I'm doing everything perfectly. And while I am, of course, practically perfect in every way, it made me sigh and laugh at the same time.

I will get the official results in a few days, but the test went as follows: No Lantus, No Novolog. Fasting sugar: 112. Drink given (ah, vanilla Boost, how I long for thee...) 2 hours into the test - 281. Yeah, bad. 281 is the highest sugar I've seen since diagnosis. (6 months ago MMTT 2 hours into it was 245.) It really confirmed to me that my pancreas is dead in the water. One hour later - 219. Huh. Something brought it down. One hour after that - 165, and a half hour later, I was at 134. So it would appear I have some pancreatic function after all. Or I did that day, anyway. This makes me HAPPY. VERY HAPPY. If only we could get that function to kick in a little EARLIER, that would be fabulous. It would also be "non-diabetic" so, you know....


Then I had a "physical exam" which basically consisted of the doctor telling me how much better I looked than when I first began, "so much more color in your face!" and he takes full credit for that, and seriously, he's said this every time he's poked his head in when I've been there (exams aren't standard every time I go). "Doesn't she look better? Do you remember how she looked a year ago?" which kind of translates to "you looked like a steaming pile of dog poo when I met you. I congratulate myself that you no longer do so."

I left, ate lunch and dinner (with appropriate boluses) and my sugars didn't come down at all, and I fell asleep in the 160's. SEE how my pancreas knows when I'm in the office? It's kind of a smart little organ, but instead of focusing its efforts on messing with me, it needs to focus its efforts on producing beta cells, although I'm sure messing with me is far more fun.

So no more study for me. All done. I can't believe I started this 2 years ago. Wait, yes I can. The results will be published in June, and then they will unblind everybody, and they can tell me whether or not I got the drug, and in what dosage. I was not aware of this, but apparently of the 3 "arms" that got the drug (1 placebo "arm") there were 3 different dosages. So that'll be interesting. I wonder if I'd gotten more drug, if I would have gone off insulin as they had 5 of 14 patients did. And yet it was stopped because it was "ineffective". Whatever. It was pulled because it was expensive. Period.

But that way lies craziness. I got what I got, and unless I have a time machine and a way to break into the randomization process of drug studies, I can't change it.

I'll have a new a1c soon, and official C-peptide levels, which will result in another boring numbers post. I'll bet you're all looking forward to that with baited breath. I know I am. (The thing is, I really am. This is my body we're talking about, you know.)

Big Pharma - helping me - but screwing you over.

Got the results from the mixed meal tolerance test in Utah. A1c is 5.8. Awesomeness. C-peptide started out really low, but it went up to 2.7, which is really quite good. Honeymooning 21 months after diagnosis? Also awesomeness. My pancreas still works, baby, and even if it's not doing its job completely, I'll take what I can get.

The big news, though - the day I went up there, was the day the office learned that the drug company is pulling all studies of this drug. END. NADA. NOBODY ELSE GETS IT. I did Protege, which had already stopped enrolling because it was full, but Protege Encore? (same drug/same dosage) OVER. Subcue? (drug give with needles instead of infusion) STOPPED. Everybody was in complete shock, they couldn't figure out why. The official reason is that the efficacy goal wasn't reached.

HOW could this drug not be effective? The office I go to has the largest enrollment, and they've seen incredible results. 3 people off insulin, snacking on Snickers bars. Nobody's Lantus dose is over 12, and they've had many people drastically drop - like from 30 to 6. And yes, most people stay on insulin, but the main goal of the drug was to drop insulin usage and extend the honeymoon - which was totally happening. Maybe other sites were teaching their subjects differently - i.e. saying they didn't need to manage their diabetes, see if the drug does that - I don't know, but saying the drug is ineffective just blows my mind, and everyone else working with it.

It's also supposed to decrease the number of lows, and you want to know how many hypoglycemic events I've had in the last 6 months? TWO. And both times, I know the reason why (more exercise than usual). I am no longer terrified of going low - I mean, I still carry candy, but I hardly ever use it. That right there makes it worth it.

You know, in the beginning, I would Google all the time, trying to find people that were in the study, see what happened to them, and I would find little snippets here and there, 100% positive. I still do that, actually. And I did see on one board somewhere (and I can't find it now, which is driving me crazy) a comment from someone that struck me as paranoid. It was when Eli Lilly bought into the study (it used to just be MacroGenics, and it happened while I was enrolled) and he said something to the effect of "Eli Lilly always buys into Type 1 studies that look promising, says they aren't effective, and then kills them. Just watch. That's what will happen." And spookily enough, here we are. Eli Lilly was in charge, declared it ineffective, and killed all the studies with teplizumab.

It's almost enough to make me a conspiracy theorist. I mean, the dude predicted it. The press release (found here) says it was an independent committee, but hmmm....

(The office also found Eli Lilly much harder to work with. Reimbursements for travel and other payments started taking much longer to get.)

I don't know why a drug company would kill it, though. I mean, most people don't go off insulin. They still need the test strips, the needles, the insulin, the money makers for the drug companies. They just get an additional drug, which you think would be win/win for the drug company. Make diabetes MORE expensive, but with the added benefit of extended honeymoon/fewer lows/increased quality of life for the diabetic. But the whole thing stinks of money somehow - maybe they wouldn't get people to pay for the drug, after all, every doctor I've ever mentioned to that I took this, pauses for a second and says "that has got to be one expensive drug." So possibly they were worried they'd get it approved only to have it sit on the shelf as insurance companies and patients opt not to pay for it.

The whole thing just really really bothers me. I don't like the feeling of not trusting the data. What other drugs were stopped in the past and/or will be stopped in the future? I don't like that nobody else will get this drug, when I would totally recommend it to anybody newly diagnosed. I don't like feeling like the search for a cure has taken HUGE steps backwards, all because of the almighty dollar.

But hey, MY numbers are good. I'M lucky, I guess. But there should be more than just a handful of us.

FINALLY!

Ok, so I finally got the results - C-peptide levels are right around 2.5. Lower than last time, dang it. (used to be 3.5). But still pretty good for a Type I diabetic 16 months after diagnosis. So...good news, I guess. The honeymoon is still going on - even if my body's not doing AS much of the work as it was before.

I'm not sure what my baseline C-peptide was, I do know it went up after the first infusion, my guess is I'm right around baseline. Evidence again that the first infusion did much more for me than the second one. I really think timing is critical on this drug. The sooner you get it, the better.

Also, A1c was 5.9. Awesomeness.

Waiting Now

I just went up to Utah again for another mixed meal tolerance test. This test marks the one year anniversary of my first infusion. It measures C-peptide levels, and will tell me if I'm still making insulin.

So now we wait. Dun-dun- dun. It should only be a few days, and then I will have a new a1c to record, and some new valuable information.

Previously, after each one of these, my sugars have been completely normal after the test, which told me my pancreas handled the Boost drink pretty well. This time, 160's. So, not dangerously high, but not exactly normal either. It makes me think I'm still making some insulin, but not as much as I used to. We will see what we will see.

My fasting sugars haven't been fabulous lately, either. The doc told me to wait a few more days, and if they were still high, to up my Lantus back up to 10. (Sigh....) But I'm not complaining. 10 is still a very low dose, and the control is still very easy.

Upon coming in, the nurse said "Did you SEE Popular Science March 2010?" Um, no? I don't make it a habit to read Popular Science....she said there was an article written by one of the very first patients to ever get the drug - and after NINE YEARS, her body is still making insulin, although now it is starting to go down. NINE YEARS of honeymooning is pretty amazing. So -nine years from now (I guess 8, maybe, since I've had the first year) - they might have a really great artificial pancreas, or a stem cell based cure, or nothing, I don't know. Who can predict, really? But I choose to be hopeful.

Here is the article - really interesting stuff.

Just for the record.

That anxiety I mentioned? (I did mention it briefly, it's OK, you don't have to look through old boring posts.) Turns out, it's a possible side effect of the study drug (teplizumab). Who knew?

It's gotten much, much, better. So that's good.

Oh, and the burning feet? Also a possible side effect. Fabulous. And that hasn't gone away. It's hard to know, though, because nerve damage is also a side effect of diabetes.

(I just had Thanksgiving dinner. It was yummy. I hope I managed to dose accurately.)

I am so putting up Christmas tomorrow.

Sigh.

Last time, 3 days after I got home from the infusions, the lows began. This time, not so much. I'm trying really, really, hard not to be disappointed about this. After all, this drug is new, there are no hard and fast answers. Still. Sigh.

Heading Home

I am sitting at the airport waiting to go home. I can't wait. I am so homesick, but all will be remedied soon.

The infusions went well, the rash did appear, but wasn't nearly as bad as it was last time, and I passed all my labs and got the full dosage of the drug. I kept worrying that I would get an infection right before, or the swine flu while I was there, just that something would happen to interfere with me getting the drug. Nope. Got it all. Whew.

I have more anxiety than I ever used to. More fear, too. I don't really know what to do about that.

My sugars were a little wonky up there. Nothing huge, but it did spike here and there, and my pre meals weren't quite where I liked them. One day I woke up at 148. You see, not horrendous, but not good, either. This added to my fear that I was getting sick, and would fail the CBC they ran (almost) daily. I did pass all my labs, but let's just say I don't want to run an a1c right now. Give me a few weeks at home, in my regular routine, with no restaurant meals and homesickness added to the mix.

This disease, though, it likes to rear its ugly head and remind you its still around and vying for control. I hate it when that happens. It's very discouraging. So now every time I work out I visualize myself beating up diabetes. It makes the workout a little more fun.

I got to the airport today really early (I'm a little anxious to get out of here) and stopped to get lunch. Pulled out my Novolog and bam! Dropped on the tile floor, and thus I have another bottle completely broken. I had just opened it, too. I always travel with extra now, (thanks to 3 month supplies coming mail order - I just make sure I'm home when it's delivered so it doesn't sit in the heat), so I reached in my purse to get my other bottle only to realize that I had put it in the checked luggage. I NEVER do that. I ALWAYS have extra with me. Today, though, have now rendered that "never" and "always" complete lies.

My hands smell like insulin now. It's not a pleasant smell.

So I sat and stared at my lunch wondering what to do now. I had one of those damn spikes post breakfast (191 1.5 hours after - I felt weird, so I checked) and my pre lunch was around 135, so it had come down, but see, not exactly where a pre meal should be. Seriously, what would you have done? With airport waiting time, flying time, etc., it would have been about 4 hours before I had access to my Novolog. I couldn't decide if I should eat, and just issue a correction dose later, go back to ticketing and ask if I could get to my insulin, or what. In the end, I ate a little of the broccoli, tossed the rest of my lunch ( bye bye $10!) and bought a bag of almonds to eat. I figured that was better than not eating at all, but low carb enough that it wouldn't spike me too badly. Right decision? I have no idea. I have candy with me just in case.

Then I stared at all the people who were eating ice cream cones and scones, and I felt a huge surge of envy. Normally, I'm OK with the fact that other people can eat whatever and whenever they want, and I can't, but today it got to me. I blame the homesickness. Or the weather. I always like to blame Utah weather for all my problems.

Anyway, HI EMILY, it was fun to meet you, and I am happy to be going home. Hopefully this newest dose will do its thing. I'll be watching, and beating up diabetes on a regular basis.

It Begins

Tomorrow I leave again for the next set of infusions.

I'll let you in on a secret. I don't want to go.

I don't want to be cold for 2 weeks plus. I don't want the nasty rash. I don't want to feel like crap for the first week. And mostly, MOSTLY, I don't want to leave my family. I miss them already. And frankly, it's a little dull up there.

Morning - labs, infusion, while I read or whatever. Afternoons and evenings, seeing people, shopping, hanging out. It sounds fun. And it is. For the first week.

See, last time, I thought 2 weeks would be doable. And now I know. A weekend away from your family - good. 2 weeks - too long.

My husband says it'll be better - it'll seem shorter since I've done it before. He says it'll go by quickly, and the family and friends I'll catch up with will help me deal. He's nice. A bit delusional, but nice.

Of course, I have a choice, and I'm choosing to go. Because nothing would make me happier than saying "Remeber 2009? That was the year I was diabetic."

In conclusion, obviously I like to start sentences with the word 'and.'

Still honeymooning - I have proof!

So, last week I went up for my second "mixed meal tolerance" test, which is a lovely procedure in which they pull blood, and then give me a Boost drink (vanilla! I asked why they couldn't do chocolate, and they stared at me blankly and could give no real reason. I like to think the next study patient might get chocolate thanks to my efforts).

After my lovely "meal", which I have to drink in 5 minutes (not hard) they pull blood every half hour for the next four hours.

Oh, did I mention I go in fasting, having taken no insulin the night before? It's such a party.

Based on these results, they decide whether or not I am eligible for infusion. They are mainly checking C-Peptide levels, because if there is no C-peptide activity, then there is no insulin production to preserve, thus making their efforts in vain. (Although I do wonder if someone who's been diabetic for years could have some positive reaction to the drug. Maybe that'll be their next study.)

I am happy to report that not only do I still have C-peptide activity, my levels are higher than they were before! 3.5, in fact, which is fairly high, even for non diabetics. That is excellent news.

So my next infusions start towards the end of October. If this dose helps as much as the last one did, well....fingers crossed.....

They ran another a1c, too. 6.4. Not as good as the last one, but I think my last one (5.3!)was so low due to multiple lows as I kept having to figure out my insulin:carb ratio that was constantly changing. Still, 6.4 ain't bad. I'll take it.

Statin, statin, who wants a statin? Do I?

So, I switched PCP's recently. The new dude ran a lipid profile, since the one I had done at diagnosis was hideously bad, but nobody takes that as accurate, since high sugars also bring up your cholesterol. (Seriously, is there anything high sugars do not screw up?)

Anyway, the LDL was high, and he sent me a card with the results along with a prescription for simvastatin, the generic for Zocor. The rest of the numbers were good, btw. Triglycerides, HDL, all that. And it is light years better than what it was in January at diagnosis.

I'm a little torn about this. On the one hand, I know high cholesterol is bad, especially for diabetics. Bad, bad, bad. On the other hand, I've been reading about statins, and they seem to be pretty well tolerated in for short-term use, but long term, the side effects and risks really start to outweigh the benefits.

The thing that really concerns me, however, is that they have recently learned that they seem to lower your blood pressure as well, which has a lot of people saying "Great! 2 risk factors lowered in one drug!" For me, though, it is not uncommon for nurses to take my blood pressure multiple times, saying "hmmm....that's a little low...let me recheck." And I am constantly hearing "Is your blood pressure usually this low? Is this normal for you?" My last BP 2 days ago was 80/50. So yeah, I run low.

Plus, I'm not sure if I can take a statin while on this study, and there's no way I'm jeopardizing my status in the study for this pill. I asked the study nurse, she should be calling me on Monday to tell me whether or not it's OK.

So that leaves me staring at this prescription, wondering whether or not to fill it. What do you think?

Ahem

I went up to Utah for another blood draw (I swear, so ridiculous that I have to go up there) and they ran another a1c. The result was.......(may I have a drum roll, please)?......................................

............................5.3!!!!!

Yeah, I'm pretty excited about that. Woot!Woot!

Getting Drugged - Protege Study

I have sporadic internet access, as I sit here and get blood pulled, and drugs put in, and vital signs taken. I mean, they let me use their internet, but it’s a “pseudo-internet” that blocks all streaming video, which includes Hulu and thus makes it impossible for me to watch continuous Buffy episodes while I wait. Season 3 waits for me at home, and I believe the DVD’s are mocking me from afar.

(They don’t want their employees “wasting time” on Hulu and such. I say it’s a blatant blockage of agency. Empoyees should be allowed to waste time! They should be allowed to get fired! Choice and consequences, baby.)

So, anyway, my morning are spent in the hospital, with my afternoons and evenings free for me to whine at various friends (but I’m TIIRRED) and play “speed Sorry.” (rules invented by moi. It basically includes me moving all the kids pieces super fast so the game goes faster.)
Oh, and a few people have asked, so for the sake of clarification - the placebo in this study is just saline. Since the standard of care for diabetics is self management (in my case, shots), there wouldn’t really be anything else to give me - so it’s either the drug or saline solution. I like to think it’s the drug.

On the plus side, I am now considered “immuno-suppressed”, and with my wacky immune system anyway, I’m sure the swine flu will pass me right on by.

It’s cold here. It’s almost May. Boo.

Thanks for the prayers.

The end.