JDRF awards $9 million for phase 3 Type 1 diabetes kidney disease clinical trial co-led by U of M Medical School professor

MINNEAPOLIS/ST. PAUL (1/26/2024) — Michael Mauer, MD, professor emeritus at the University of Minnesota Medical School, and research teams at the Joslin Diabetes Center, Harvard University and the University of Toronto were awarded $9 million from JDRF — the leading global Type 1 (T1D) diabetes research and advocacy organization. The award will be used to conduct a clinical trial that will test sotagliflozin — a dual sodium-glucose cotransporter (SGLT)1 and SGLT2 inhibitor — in the treatment of kidney complications in people with T1D.

Kidney disease remains a life-threatening complication for those living with diabetes. Almost half of kidney failure cases are caused by diabetes, and an estimated one out of three people with T1D develop significant kidney disease. In recent years, SGLT inhibitors have proven to be very effective in improving kidney outcomes in people with Type 2 diabetes, but there remains a lack of research on their effectiveness for those with T1D and established diabetic kidney disease.

With few approved therapies for people with T1D who have developed kidney disease and the substantial risk of kidney disease progression despite current treatments available for such patients, this study is an important step toward fulfilling an unmet clinical need and allowing these individuals to live longer and healthier lives.

“I have been involved in basic and clinical research in kidney disease in persons with T1D at the University of Minnesota for more than four decades,” said Dr. Mauer. “I am acutely aware of the severe consequences and suffering associated with this very serious diabetic complication. I am excited by the real possibility that this study, through its superb investigator team, will result in a large step forward in the treatment of this important disorder.”

The study will build on the SUGARNSALT research project, which is supported by a $1 million commitment from The Kidney Foundation of Canada, matched by a $1 million investment by the Canadian Institutes of Health Research through the Team Grant: Diabetes Mechanisms and Translational Solutions competition, launched in 2022.

SUGARNSALT is one of the largest T1D-focused kidney disease studies in the world, and it is the only phase 3 clinical trial targeting major kidney disease outcomes. This trial represents the collaboration of highly experienced clinical researchers and academic centers in the United States and Canada. This trial will add to the SUGARNSALT project by testing the safety and effectiveness of an SGLT inhibitor in slowing the further loss of kidney function in people with T1D and kidney disease. A top line goal of the study is to provide data demonstrating a positive benefit of sotagliflozin for people with T1D who are suffering from diabetic kidney disease, which could support regulatory consideration in that population.

The trial will be conducted at 16 sites across the U.S. and Canada. Enrollment is expected to begin in May 2024.

Drs. Mauer, Alessandro Doria with Joslin Diabetes Center and David Cherney at the University Health Network, University of Toronto are the principal investigators for the clinical trial. 

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