Triple Therapy in T1D: JDRF Researchers Launch a Clinical Trial

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Since its discovery nearly 100 years ago, insulin has been the only effective treatment for type 1 diabetes (T1D). Improvements in insulin delivery—from the first human insulin in the 1970s to the introduction of insulin pumps and continuous glucose monitoring (CGM)—have been beneficial, but an overwhelming majority of people with T1D—83% of youth and 79% of adults—still do not have their blood sugar well controlled. That gives rise to complications, including heart, kidney and eye disease, and makes the burden of T1D considerable.

But there are drugs that could, potentially, help diminish the risk of blood-sugar swings. One is called GLP-1, which works, amongst other mechanisms, by increasing insulin release from the pancreas. It is approved only for type 2 diabetes. Another is an SGLT inhibitor, which is responsible for glucose (re)absorption in the kidneys and intestine.

Clinical trials with insulin—GLP-1 plus insulin or SGLT plus insulin—have shown improved blood-sugar control, but they do not get a majority of adults down to 7% or lower with HbA1c. So what if you combine the treatments: insulin + GLP-1 + SGLT?

That’s what Paresh Dandona, M.D., Ph.D., at SUNY, and John Petrie, M.D., Ph.D., at the University of Glasgow, wanted to test. Both are global leaders in the treatment of T1D.

They now have a clinical trial, funded by JDRF, to explore the combination of insulin, an SGLT inhibitor called dapagliflozin (Farxiga®, marketed in Europe as Forxiga®) and approved for use in adults with T1D in Europe and the GLP-1 receptor semaglutide (Ozempic®) in adults with T1D. If successful, this trial could demonstrate that this combination reduced HbA1c to less than 7% in trial participants, possibly reduced the unpredictable fluctuations in blood-sugar levels and helped achieve other benefits such as body weight and blood pressure reductions. Taken together, these outcomes could provide a greater sense of security to people with T1D.

The clinical trial is recruiting at the State University of New York at Buffalo, and will involve 114 participants. If you are interested in participating, please call Jeanne Hejna at 716-535-1850 or jeannehe@buffalo.edu.