Fenofibrate (also spelled Phenofibrate) is commonly prescribed for high cholesterol and high triglycerides. In 2017, it was the 70th most commonly prescribed medication in the United States with more than eleven million prescriptions. However, it is not approved for use in children under 18. It is also sometimes prescribed for diabetic retinopathy (eye damage from long term diabetes), and (off label) for gout.
However, it also showed some promise in NOD mice (an animal model for T1D), and so one person took it "off label" when they were diagnosed with T1D as a 19 year old. They did not need to inject insulin for years after that, a huge result. Still later, some researchers started a Phase-IIΔ trial. These are my previous blog posts on Fenofibrate:
I had high hopes for this research. I try not to become emotionally attached to specific research, because it clouds my judgement and because most research fails. However, having one person go years without having to inject insulin was so good, and so unusual, that I was hopeful. Unfortunately, this research did not pan out.
Results From the Phase-IIΔ trial
Here is the conclusion from the result's abstract:
Contrary to the beneficial effects of fenofibrate found in preclinical studies, this longitudinal, randomized, placebo-controlled trial does not support the use of fenofibrate for preserving beta cell function in individuals with newly diagnosed type 1 diabetes.
Since my initial excitement was based on a person who did not need to inject insulin after taking Fenofibrate, it makes sense to look at the insulin use and compare the people who got the drug (in red below) with the people who got the placebo (in blue). You'll notice that the people who got the drug used a little more insulin. This is the exact opposite of success, although the difference was not statistically significant. Bottom line: it did not work.
This study used the same dose (160mg/day) that the successful "off label" used. And that person stopped taking insulin after 19 days, so this study lasted much longer than needed to see the effect. Also, the "off label" use started 7 days after T1D diagnosis, while this study started, on average, 22 or 24 days after diagnosis, with a standard deviation of 10 or 11 days. The number of people who were "in remission" of T1D during their honeymoon was higher in the placebo group than in the treated group. I put "in remission" in quotes because it is not what most people would consider remission. They still used a little insulin, just not very much. The researchers used a formal, technical definition of remission called the ADDRESS-2 definition, which is quite different than what you or I would call remission.
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
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