By: Patrick Totty
Since my diagnosis as a type 2 in 2003, I’ve participated in three Phase 3 drug studies. I am fortunate to live two miles away from one of the San Francisco Bay Area’s premier endocrinologists, Dr. Richard Bernstein (who has the same name as the famous low-carb advocate based on Long Island, New York). Over the years, Dr. Bernstein has established his office as a go-to testing facility for drugs in late-stage development.
I first started going to him for routine endocrinological exams to determine what to do about my A1c’s. As we got to know each other, Dr. Bernstein realized that I might make a good subject for one of his Phase 3 tests. For one thing, I was always on time for appointments with him, which indicated that I might be good at record keeping. For another, as we discussed various matters—diabetes, books we’ve read, the events of the day—he was able to see that I’d be able to follow and understand whatever instructions that might come with being a test participant.
For the first two Phase 3 trials, I was required to keep a daily log of my fasting numbers, as well as record any adverse effects (which I never suffered). At monthly or bi-monthly intervals, I’d come in to have blood samples drawn and undergo a routine checkup—weight, eye, ears, nose, throat, lungs, reflexes (especially of my neuropathically affected feet), and on occasion a full-blown EKG.
My first study, lasting a year, was for a version of exenatide designed to compete with Byetta. I had to inject myself twice daily, around my morning and evening meals. I am almost certain that what I was injecting was a placebo since neither of exenatide’s sweet side effects occurred with me: lessened feelings of hunger and weight loss. Dang!
The second study involved dapagliflozin, one of a new class of drugs called SGLT2 inhibitors. Unlike longer-established drugs that work on the pancreas or liver, these drugs work by making the kidneys send some glucose into the urinary tract rather than returning it to the bloodstream. The drug’s very minor drawback was having to pee a couple of more times a day than usual. However, it also had a pleasant side effect of leading to a bit of weight loss; 10 lbs.
So at the end of two studies, my experience was a draw: Placebo 1, the Real Thing 1.
The study I am in now has been going on for almost a year, and is expected to last another five. It involves dapagliflozin again, which the FDA approved for the U.S. market in 2013. However, the FDA attached a condition to that approval: The agency would like more data on the drug’s effects on cardiovascular health. I am one of the guinea pigs whose long-term ingestion of the drug (one dark gray tablet every morning) is being monitored to see how it affects my heart.
I told Dr. Bernstein when I began the study at almost age 65 that I was complimented that he and the drug’s maker, AstraZeneca, think I have another six years in me. In any case, I get regular check-ups that specifically focus on my cardio functions, so whatever I think of their optimism about my lifespan has not kept me from taking them up on their offer.
All of these studies have not cost me anything. My experimental medications, as well as my regular metformin in the first two studies, have been provided free of charge. My check-ups, no matter how elaborate or time-consuming have been free. Also, I was paid a stipend at the end of the first two studies, $400 to $500.
I could not have asked for a better situation: helping test new type 2 drugs; being under the care of a great endocrinologist and being able to interact with him; receiving free checkups, and getting a little cash sweetener in the end.
Still, I had my end of the bargain to keep up. Dr. Bernstein and the people sponsoring his tests had several justifiable expectations of me:
Keep honest records. No matter how careful test designers are, they depend on the accuracy of the data they receive from test subjects. If I was asked to record my fasting blood glucose levels every morning, I was expected to record honestly and consistently. However, there was the occasional day when I’d forget. Although there was a temptation to enter a made-up number—who was ever going to know?—I just fessed up in the comments section: “FORGOT TO TEST.” I knew that if the testers could see hundreds of numbers from me, the occasional gap could be filled in by their own sophisticated mathematical models.
If you are on placebo, grin it and bear it. I realized a few weeks into my exenatide test that I was on a placebo. None of the much-touted beneficial side effects of the drug visited me. My weight did not drop, even slightly, and my appetite was as strong as ever. It was a disappointment that certainly sucked most of the life out of any enthusiasm I had for the test. However, implicit in my volunteering to participate was a commitment to see it through so that the test sponsors could get an accurate take on a head-to-head comparison between placebo and the real thing.
Understand that drugs force your body to do things. I wrote about my dapagliflozin trial in another blog and one of the comments a reader made was that taking a drug that forces the kidneys to do something they do not usually do can’t be good. After all, people with diabetes are already taking drugs that make the pancreas or the liver work differently. Why add another burden to the body?
It was a good point, one that every person with diabetes has to consider. One of the things our disease makes us do is find ways to compensate for our bodies’ diabetic malfunctions. There’s no way around it. If we want to lower our blood sugar, in most cases we have to take drugs. Those drugs work around our bodies’ limitations by making them do things they no longer do well or making them do them differently. Either way, there’s a price we pay—let our out-of-kilter bodies continue with uncontrolled high blood sugars or alter their activities in artificial ways to lower those sugars. I vote in favor of the drugs.
Participating in Drug Trials
Depending on where you live and your demographic profile (age, sex, weight, ethnicity, etc.), you might be able to enroll in a drug test trial. Most trials pay a stipend for participation and often provide other drugs and medical services as part of the deal.
The drawback is that most trials by necessity are located in large metro areas, so if you live out in the country or a small town, there are fewer opportunities for participation.
Two organizations whose websites offer information about current and upcoming trials are:
Paid Research Studies: