Bravo Cat Study

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I believe someone on the groups Facebook page has a cat in the study and is having good results with it
 
A couple of questions...

  • Clinical trials often involve a placebo arm of the study. They make no mention of whether there is a placebo arm. Is there the possibility of your cat being randomized to a placebo medication?
  • If there is no placebo arm, how far along are they in the research? In other words, what have the preliminary results told them so far?
  • What kind of insulin are they using? Some oral diabetes meds, such as metformin, burn out the pancreas. Thus, there is no hope for remission. What is the mechanism of action of this insulin and have any cats gone into remission? And if they won't tell you, why won't they tell you?
  • Personally, I'm not entirely comfortable with clinical trials that are run out of a vet's office. Most vets want to have nothing to do with research once they are out of vet school. The same is true of most MDs. The majority of clinical trials are run out of universities. I live in very close proximity to a top tier vet school.. This study is being run out of a feline special practice. How much are the vet's being compensated for enrolling cats in the study?
  • How many clinical trials has the vet been involved in?
  • A vet's office isn't staffed 24/7. If there is a problem with the study medication, how are emergencies handled? Who is responsible for the cost if there is a complication due to the drug?
  • What are the potential side effects? How many cats had negative reactions and/or died in the course of the development of this drug?
 
Sienne and Gabby (GA) said:
A couple of questions...

  • Clinical trials often involve a placebo arm of the study. They make no mention of whether there is a placebo arm. Is there the possibility of your cat being randomized to a placebo medication?
  • If there is no placebo arm, how far along are they in the research? In other words, what have the preliminary results told them so far?
  • What kind of insulin are they using? Some oral diabetes meds, such as metformin, burn out the pancreas. Thus, there is no hope for remission. What is the mechanism of action of this insulin and have any cats gone into remission? And if they won't tell you, why won't they tell you?
  • Personally, I'm not entirely comfortable with clinical trials that are run out of a vet's office. Most vets want to have nothing to do with research once they are out of vet school. The same is true of most MDs. The majority of clinical trials are run out of universities. I live in very close proximity to a top tier vet school.. This study is being run out of a feline special practice. How much are the vet's being compensated for enrolling cats in the study?
  • How many clinical trials has the vet been involved in?
  • A vet's office isn't staffed 24/7. If there is a problem with the study medication, how are emergencies handled? Who is responsible for the cost if there is a complication due to the drug?
  • What are the potential side effects? How many cats had negative reactions and/or died in the course of the development of this drug?
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Hi, I have 20+ years experience in the pharmaceutical industry, and while some of your thoughts have some merit, I just wanted to address a couple of them.

You wouldn’t have a placebo arm to a study when you know that not giving a medication could cause immediate death or complications. As they are asking for diabetic cats for the study it would be unethical to not treat as a cat could easily develop DKA if denied insulin especially as the the placebo would need to be continued for the length of the study and medications do exist to treat the ailment. These kinds of trials are more likely to compare an existing medication to something new.

Many trials run out of wherever the patients are located - doctors offices and hospitals - the results are sometimes compiled by someone in a university but more often than not they will be sponsored by a pharmaceutical company and data analysis etc will be done by the medical professionals running the trial.

It doesn’t really matter how many (if any) trials this vet has done - if he is doing a trial for diabetes, one can pretty safely assume he has an interest in this area of veterinary science. Regardless of what we think of some vets they have multiple years of training and education and would be qualified to run a trial
 
I was just looking at the website again - multiple veterinary practices are involved so more than likely the pharmaceutical company is running the trial. Also, noticed all cats will receive the trial medication which makes me think the research is quite advanced - it may be a human medication that they want to try on cats (as many medications are) or preliminary trials have already been done - I’d go for the human medication theory though as there wouldn’t be enough money in developing something for diabetic animals. Also the website states they will pay for the cost of a veterinary care for the duration of the trial. I’d give it a go if I was in the US.
 
Our vet asked us if we were interested back in June, and we were considering it. Unfortunately Rocket was diagnosed with Acromegaly shortly after, and was no longer eligible. At any rate, if I remember correctly, one drawback for us was that since the medication was not yet approved for cats, theoretically your cat could do well on the medication but not be able to continue once the study is over.
 
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