Diabetic’s Role in Clinical Trial Prompts Health Gains

A shy young woman who had struggled with obesity and had been battling Type 1, or “juvenile” diabetes, since childhood, she joined a clinical trial that was testing whether a new class of drugs usually used to treat Type 2 diabetes would also be effective for treating Type 1 diabetes.

Wallace says her physician recommended she join a UB study after they found themselves at a stalemate with her treatment.

“We were losing,” she says. “We were trying all different options and I felt like I was losing hope that things would ever get better.”

Instead, Wallace’s involvement with UB’s diabetes clinical trial set in motion a virtuous cycle that has led to more improvements than her health.

The treatment she received helped lower her blood sugar and helped her lose weight, which helped her manage the disease better, allowing her to get on with her goal of going to college and ultimately starting a career in her chosen field.

Along the way, the contacts she made with clinicians and the other participants in the study provided a ready-made support group to help her maintain those gains after the study was over.

“It helped me to gain better control of my health overall,” Wallace says.

Because the pancreas is not producing insulin, patients with Type 1 diabetes must take the hormone every day, either by injection or insulin pump, and test their blood-sugar levels every three to four hours, particularly around meal time.

Disruptions in the amount of blood sugar — either too much or too little — can cause immediate side effects, such as fatigue, irritability and seizures, and over time can lead to much more serious complications, including nerve damage, kidney disease and blindness.

Doctors regularly perform hemoglobin A1C blood tests that translate into average blood-sugar levels over the previous three months to help patients manage the disease.

“Basically, your life kind of runs off of these numbers,” Wallace says. “For many years I’ve had hemoglobin A1Cs that have been out of range, and that was due to multiple combinations of different issues going on in my life.”

The daily maintenance routine and constant attention to one’s carbohydrate intake, the fatigue and the mood swings that accompany the disease often put a strain on patients’ social relationships, particularly among children whose peers may not understand the disease or its treatment.

Wallace says she experienced problems with weight gain, which further exacerbated her condition. For years, she wanted to have bariatric surgery to help bring her weight down, but doctors said her A1C levels were too high for consideration.

“My blood sugars were out of range for so long,” she says.

It wasn’t until she met Kathleen E. Bethin, MD, PhD, clinical associate professor of pediatrics in the Division of Endocrinology and Diabetes, that she was able to regain control.

Bethin is not Wallace’s primary care physician and she wasn’t consulted as a specialist on Wallace’s case. They met when Wallace volunteered for the multi-site, industry-sponsored clinical trial of the drug sotagliflozin that Bethin was running at UB.

Nevertheless, the nearly parental affection and regard she has for Wallace is apparent.

“Cathie’s control wasn’t the best,” Bethin says, “and part of the issue was that she was very much afraid of low blood sugars.”

Bethin says she worked closely with Wallace to calm her fears and reinforce the progress she was making.

“Even between visits, she would call us up if she had any concerns.”

Sotagliflozin is a member of a class of drugs that have been approved by the Food and Drug Administration (FDA) for treatment of Type 2 diabetes. It works on two fronts: by blocking absorption of sugar in the kidneys and in the gut.

“It slows down how quickly you absorb sugar, helps excrete more sugar in the urine and also sends a signal back to the brain making you feel fuller, so that you eat less,” Bethin says. “The drug potentially could lower blood sugar without causing too low a blood sugar, and also may help people lose weight.”

Taken in combination with insulin, this class of drugs has been shown to help Type 2 patients stabilize blood-sugar levels before and after meals.

Bethin’s trial was meant to determine whether sotagliflozin could help Type 1 patients. She says all of the test subjects in Buffalo taking the drug had good outcomes compared to the control group, but perhaps no one more so than Wallace, who was able to cut her average A1C in half.

“I think the important thing is she didn’t even know that she could feel better. She didn’t know that she was feeling bad because she was so used to having high blood sugars,” Bethin says. “Once we brought her into the target range, she felt so much better that she felt empowered to keep her blood sugars in a good range.”

In addition to feeling better, Wallace was able to get the bariatric surgery she wanted. Losing weight, in turn, helped her manage her blood sugar better and that gave her the confidence she needed to achieve the goals she had set out for herself, which included a career in human services.

Following the study, she enrolled in college, and recently started a job as a peer health specialist at BestSelf Behavioral Health Inc., a local provider of mental and behavioral health services.

“In the paperwork, you’re identified by your initials and a number,” Wallace says, “but when you’re working with the researchers, I didn’t feel that way.”

“We had an identity — we were Cathie, we were Suzy, we were whoever our name was — and we got a chance to know each other a little bit more and talk about how the medicine allowed for different opportunities to be better.”

Through Bethin’s research program, Wallace says “she’s not only helping me, but other future young diabetics out there to have a better quality of life.”

Results of the study were written up in the New England Journal of Medicine last December. The drugmaker submitted an application in early 2018 for FDA approval of sotagliflozin to treat Type 1 diabetes.