Posted on 05/09/2010 10:40:42 AM PDT by bert
I am posting my thoughts on my participation in a drug trial for a new drug to treat type II diabetes. I have been diagnosed for 6 years but it has been in the last year that my A1C and blood glucose number have crept up to 7.1 and fasting level of >140
My primary care doctor suggested me as a possible participant because my numbers have recently crept above 140 and 7.1. He is a family practice doctor and a member of a medical group with a specialized team that provides care for diabetes patients. The team consists of several nurses and lab techs working under a physician. Additionally, there is a clinical research team that allows group physicians to participate in various research projects in addition to their normal practice. All the above are combined in the trial involving me as a participant.
The details of the study can be found on the following link
http://clinicaltrials.gov/ct2/show/NCT01071850?term=diabetes&rcv_d=14
After a week of taking placebos in the prescribed manner, making the blood sugar meter pricks at the correct time twice daily, I was accepted as a suitable test subject. The initial meeting included a 22 page agreement with several signatures and admonitions and detailed description of the drug trial process.
Each morning I take the provided medication consisting of one small tan tablets, 6 larger tan tablets and one orange capsule. I make a blood finger prick with an Activa meter. In the evening, two hours after eating I take another sugar check and two orange capsules. On the morning I visit the clinic, I provide a first morning urine sample and take the pills at the site. The visit is after fasting, nothing but coffee till they are finished with their work.
Participants in the double blind trial will take drugs in the prescribed manner not knowing what they are taking
• A Placebo will be given to 1/6 of participants
• The tried and true, well known diabetes drug metformin will be given to 1/6 of the group
• Specific but different amounts of the trial drug will be given to 4/6 of participants
I am provided with a printout of all the finger prick data and have plotted it in excel. It is obvious that both the morning fasting level and the evening levels are trending down. That indicates to me that I am not on straight placebo.
Of interest might be the definition of diabetes mellitus. When you review the internet sites there is some difference of the point at which it is diagnosed.
My interpretation of what I have read and what I have been told/ instructed follows
There are 5 numbers involved with the diagnosis. The diagnosis is made purely on test values.
The first is A1C level. A positive diagnosis is for A1 C > 7.0.
There are 4 blood sugar test values of interest. Normal is defined as >70 to <110. A value of 140 is apparently the final diagnosis. Fasting Blood Sugar > 140 on two occasions is the certain diagnosis for Type II. I have been unable to get a firm handle on the gray area between 110 and 140. The number of 126 was used by my doctor and the diabetes specialists as the level at which diagnosis for diabetes mellitus is made.
However, as long as the A1C value is lower than 7.0 there is not much concern, no medication, no fussing with a meter, watch the diet, lose weight, be sure to exercise .
As a matter of passing, 126 is 14 points less than 140. That is, it is an arbitrary 10% points lower than the 140 line at which you are definitely diabetic. At 126 concern begins. Some call it pre diabetes. Others say there is no such condition, you either have it or you don’t at 126.
In modern medicine, numbers are everything. Determining and interpreting members and their variance from established norms is the name of the game. Blood tests are a primary, perhaps the primary source of numbers. On each of my visits, numerous blood samples are taken and will be split into 22 test samples.
This post is being written in the Clinic room known as the PK unit. PK is Pharma Kinetics. It is a regular examining room except it has two recliners, a TV set, a large collection of books and magazines, lots of crayons and and coloring books, a deck of cards and a wifi connection. The PK procedure consists of taking this morning’s pills and then submitting blood samples at two hour intervals for a total of 4 samples over 6 hours. The procedure tracks the drug level in the blood over time. There were also two urine samples, one at the beginning and one at the end.
I think this post might be of interest to the diabetic ping list and will be followed up with comments.
Later read. Thanks for the post.
By the way, the lowest number I have recorded is 108 after hiking 5 miles in the rain. The highest was my personal test after drinking a mug of very sweet coca and was 262. There are only a few tests >200 or < 110.
I am told that as my body adjusts to the lower blood sugar level induced my some medication, it will accept the lower level as normal and energy level will normalize.
Additionally, I have lost approximately 9 pounds in 6 weeks. The weight loss might be attribute to the drugs, but I have also been exercising and watching sweets.
I have experienced none of the possible side effects noted in the trial literature.
I hope this is not boring the group
I checked my blood pressure before and after reading your post and the reading remains low. ;-)
There seems to be a number of FReepers with diabetes or having relatives with diabetes. How your trial progresses should be interesting.
I was diagnosed with A1C of 7.3 in September. Down to 6.3 in January and 6.1 2 weeks ago. Lost 20 pounds watching sweets & some exercise. Other than that I’m totally confused by what I’m supposed to do, not do, carbs, sugars, etc. TOTALLY confused! AGH!!
Did I mention I’m now starving all the time? Lots of fun for sure,....
Please just in terms of "a normal days pay" or perhaps "twice my regular hourly rate"... Something along those line.
I have always wondered. Some years ago,, my brother got an 'exprimental' treatment - which cured him. Before he took the treatment, he was told there would be no cost if he chose to 'participate'. One month after he got home, he got socked with a 12K bill - which the center refused to detail.
Was wondering what your experiance turned out to be...
thx
They pay me $40 per visit plus breakfast
If you have changed your behavior, i.e. more exercise, how can they possibly judge the effect of the drugs? Wouldn’t all test subjects follow exactly the same life style they had been living for the study to have any value??
Diabetes cannot be cured. It can only be controlled.
Thank you very much for the quick rely.
Breakfast after the blood draw, no doubt.
Amy I assume no other talk of billing for treatment?
Yes, they were quite clear that I would incur no charges.
You used the word treatment. I am not being treated in what would be a normal situation. The trial is conducted on behalf of the drug company by a section of the medical group of which my personal doctor is a member.
Prior to the trial, I was not on any diabetes drug or regimen other than lose weight, diet ( not overly strict in my case ) and exercise.
When the trial is over, I will still have no diabetes drugs unless my doctor thinks it is necessary. That remains to be seen.
......If you have changed your behavior, i.e. more exercise, how can they possibly judge the effect.....
That is a question I asked them myself. The fact is, my behavior did change. Winter this year was longer and worse than normal here. I did not get out and exercise as “normal” for winter. I am older also, just turned 68 and it is hard to judge the effect of just plain getting older. I told them it was my intention to be more aggressive in my exercise and stop eating candy and deserts. I told them I would cut down on portions and try to lose some weight.
That is I was going to modify the behavior of the last 4 months to a more normal state.
That was said to not only be ok but good. I was advised the medication might cause additional weight loss but it would be monitored and unless I shrank away to nothing, would be ok.
So the answer is it apparently is not a matter for concern in the trial
AH
Thank you for the added data.
I guess they are wanting to confirm no nasty side effects. Good luck to you!
They have had two previous trials where they learned there are no nasty side effects.
There are side effects constipation, insomnia, nausea were the worst I remember.
I just completed a one year test of a different diabetes drug called Taspoglutide. It amounts to a shot in the stomach fat, much like an insulin shot, once per week and a brown capsul once per day. They’re also giving me free Metformin, 2g/day. And of course the $40 per visit to “help with parking expenses.” Hell, parking’s free, but it sure helps with the gas!
I can’t even remember when I was first diagnosed but it’s been ten or twelve years. I remember going to a dental surgeon for some work and when he took my blood pressure it was 450 over 350. He got quite excited. “Calm down Doc! I didn’t do it on purpose!”
That led to the diagnosis. I take a hand full of pills every day, now, and it was pretty much under control for a while. Just after I turned 65 I started having the same problem you did. My ‘magic number’ was 150. “If it goes over 150,” they said, “cells are dieing.” My feet were numb by then, and the circulation in my legs is very bad. I can’t walk more than a block without sitting down, and I have no stamina at all. So when my a1c reading went over 7.0, they asked if I wanted to join the research group.
A friend of mine’s wife was a GP (Guinni Pig) for the drug Byetta. Taspoglutide is similar to that. She lost 30 pounds during the testing. I lost 20 pounds in the first two months and I still believe it was because of the nausia. Who wants to eat when you’re pretty sure you’re just going to chuck it all up again? It looks good going in, but....
I have a hiatal hernia, and so I am sensitive to excess stomach acid. When I started the Taspoglutide, I could hear stomach acid sloshing when I rolled over at night! I spoke to the research Doc and while he denied that the drug would do that, he prescribed an acid blocker anyway. 90% of the nausia went away and so did the weight loss. I’m still holding pretty steady at 15 pounds less than before.
Sure way to lose weight is to eat something that makes you sick to your stomach, I guess.
We’ve set up an exercise room in the basement, and during the winter we work out while watching Glen Beck. It’s all I can do to stay on the treadmill from the beginning to his first break. Not enough blood getting to my legs. The exercise still wasn’t enough to prepare me for Spring chores. But like you say, it’s hard to tell whether it’s the diabetes or just plain old age. I just learned that my thyroid has gone hyper on me, and could be the source of some of the symptoms I’ve been blaming on the diabetes.
But you are right about the “interesting experience”. I never realized how interesting the workings of the human body could be. It’s all interconnected, and the individual parts communicate with chemistry. I’m told that even white blood cells can be seen stopping at nerve ‘nexis’ for a moment in capilaries. Why the Hell do you suppose they do that?
When you eat something, the gut creates a chemical signal informing the entire body that food is on the way and that the cells can eat all they want. But the chemical only lasts a few seconds. What Taspoglutide does is simulate that chemical for longer periods, making the cells take in the excess sugars from the blood longer.
Seems to be working so far. My numbers have dropped from >150 to an average of 115 to 120. I guess I can live with that!
Of course we change our behavior after being with any condition. I have learned, with help of the Geckle Institute at GBMC (Greater Baltimore Medical Center)about carb counting. I have been struggling with hyper-tension for about 20-25 years. I’m 54. Since I was a kid doctors told me my blood sugar was a little high. In 1999, I was diagnosed with type 2 diabetes. That’s when the glucose bar was lowered to 142. (I think).
Anyway, Since then, my prescription of 8MG Avandia (once daily) helped the precription of 300 MG Cartia (once daily)to keep both my glucose level and blood pressure in better control. I test between 100 and 110 glucose fasting with the prescription meds. Still working on the blood pressure but at least it’s not as erratic as it was. That was knews to my doc. On the next visit he did some research and found that others have reported the same effects.
“...Some years ago,, my brother got an ‘exprimental’ treatment - which cured him...”
Diabetes cannot be cured. It can only be controlled.
++++++++++++++++++++++++++++++++++++++++++++++++++++
Yes, there is a certain segment who lose weight, control the diet and exercise who have gotten off the meds. HOWEVER, you are not cured, you’ve just managed/controlled your condition. You may very well be put back on meds as you get older as your body begins to age.
Someday, there will be a solution to this, but once you’ve crossed a certain threshold, you can only control.
FYI. I’ve had diabetes for 4 years now....A1C is about 5.6
Were you on medication before the trials? Or were you diet controlling your blood sugar?
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