By highlandcitygirl Latest Reply 2010-06-11 19:10:51 -0500
Started 2010-06-04 13:24:01 -0500

my doctor has asked me to become involved in a " double blind" study. i am thinking about doing it, because while i'm on it , the meds and all my testing supplies would be provided. has anybody heard of this med. or been in a study ? the drug company is Takeda Global Research and Development Center, Inc.

6 replies

imsuzie2 2010-06-06 05:51:44 -0500 Report

I was once involved in a study of a cholesterol drug, (FINAL PHASE) and before I got to the part of actually taking the drug or placebo, I was dropped because my numbers did not get to the bad level they required. Told my doc I thought we should discuss changing my cholesterol med, but by the time I saw him, within a month of being dropped, my numbers got bad! LOL

I was contacted by a medical group that runs diabetes and cholesterol studies (or at least those are the studies they call me for) and I told them before I would consider it, I wanted all the info to take to my primary to get his ok. I got it. I would not do a clinical trial without my docs ok…but in your case…what Gabby and KD say would stop me cold. It seems they have your health in mind more than your doctor. I think a very fair question to ask your doctor (before you tell him no) is "how much money or "consideration" do you get for supplying patients for the study"?

GabbyPA 2010-06-04 17:05:08 -0500 Report

Here is my take on trials. Ones that are run by drug companies, I will not take part in. Ones that are being done by a University or Medical institute I will consider.

Here's why.
I was part of one run by the University of Miami in the 1980's. There were drugs involved, but they had already been tested and there were no "special interests" in getting good grades on a specific drug. In fact, metformin was one of the drugs being tested. I did that for several years and I enjoyed it.

I went to see if I would qualify for one about a year ago and it was run by a drug company. The paperwork is totally different and the things they gather are not only applied to that study, but they want to keep your info, your blood, your test results and apply them in other places. The paper work was crazy. I started getting really nervous when they wanted to keep my blood for undisclosed tests.

Now on top of that, KD's concerns are worrisome as well. So I would research that medicine and talk to your doctor about any concerns you would have.

kdroberts 2010-06-04 19:43:10 -0500 Report

I'll also add that the drug in question had already been put forward for FDA approval a couple of years back and 'denied' because of a lack of information, specifically on the cardiovascular effects. Takeda is behind where it wanted to be with this drug and has spent a huge amount of money on it already buy there are now 2 existing competitors on the market. They want to show it works and is safe.

kdroberts 2010-06-04 14:10:40 -0500 Report

Personally I would avoid it. I'm not against drug trials but this drug is part of a class that has not been proven safe long term yet. Januvia and Onglyza are the currently available ones in the same class but there is a big cloud over their safety. They block an enzyme that along with being involved with blood sugar is a component of the immune system and plays a large role in protecting against certain cancers. The cancer side of them has not been studied and the affect on the rest of the body hasn't been studied very well either.

Shipe 2010-06-05 15:40:18 -0500 Report

I am on Januvia , short time, can't see any difference in my #,s .Iam going to discuse the drug with my Dr. to see if it,s worth the risk.

highlandcitygirl 2010-06-11 19:10:51 -0500 Report

well, i guess i'm not going to do it, just got out of the hospital after 3 days , had ischemic colitis. i am not going to take the chance with something untried and something else going wrong ! thanks to all who replied.

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