New York and Montreal, Jan. 22, 2024 – Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, has awarded $9 million to researchers Dr. Alessandro Doria with Joslin Diabetes Center, Dr. Michael Mauer with the University of Minnesota Medical School, and Dr. David Cherney at the University Health Network, University of Toronto, to conduct a pivotal 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. The study will build on the SUGARNSALT research project first led by Dr. Cherney, which is supported by a $1 million commitment from The Kidney Foundation of Canada (KFOC) matched by a $1 million investment by the Canadian Institutes of Health Research (CIHR) through the Team Grant: Diabetes Mechanisms and Translational Solutions competition, launched in 2022.
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.
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, most of whom have worked together successfully on a previous clinical trial. All recognized the opportunity to enhance the impact of the trial by joining together. 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 and which could support regulatory consideration in that population.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), developer of sotagliflozin, will provide the study medication for the trial.
“There are new, highly effective therapies for kidney disease in people with type 2 diabetes and people without any kind of diabetes, but there hasn’t been a new drug approved for kidney disease in type 1 diabetes in decades. Therapy development for kidney disease in type 1 diabetes is a high priority for Breakthrough T1D, and SUGARNSALT is a phenomenal opportunity to rigorously test the efficacy and safety of sotagliflozin, a drug with demonstrated kidney and heart benefits in type 2 diabetes,” said Jonathan Rosen, Ph.D., director of research at Breakthrough T1D.
“Scientific advancement through collaboration increases opportunity and fosters innovation and progress,” said Elizabeth Myles, National Executive Director of The Kidney Foundation of Canada. “The Kidney Foundation of Canada is proud to be one of the founding partners on this significant investment to support innovative strategies to treat diabetic kidney disease. This new leveraged investment will bring this important work one step closer to treatment improvements for the patients we serve. We look forward to continuing to work with CIHR, as well as Breakthrough T1D on this novel trial and to support this now multi-national project to achieve its goals.”
“Over the past 15 years, we have built a unique network of clinical investigators in the U.S. and Canada, who share the goal of finding new treatments to prevent or slow down kidney function decline in type 1 diabetes. I am thrilled to continue to work with such an amazing group of researchers in this new clinical trial,” said Dr. Alessandro Doria.
“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. Michael Mauer. “I am acutely aware of the severe consequences and suffering associated with this very serious diabetic complication. I am excited by the very real possibility that this study, through its superb investigator team, will result in a very large step forward in the treatment of this important disorder.”
“While major advances have been made for the treatment of kidney and heart complications in people with type 2 diabetes over the last five years, treatment has remained unchanged in people living with type 1 diabetes for more than 20 years,” said Dr. David Cherney. “As a result, the risk of complications remains unacceptably high. SUGARNSALT represents an unprecedented opportunity to determine if SGLT inhibition can reduce the risk of kidney disease progression in people with type 1 diabetes at the highest risk of future kidney failure.”
The trial will be conducted at sites across the U.S. and Canada, and enrollment is expected to begin in May 2024.
About Breakthrough T1D
JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, Breakthrough T1D has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally and globally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).
About Type 1 Diabetes (T1D)
T1D is an autoimmune condition that causes the pancreas to make very little or no insulin. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death if left untreated. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.
About The Kidney Foundation of Canada
The Kidney Foundation of Canada was founded in 1964 with the overarching goal of raising funds for research. To this day, research remains a key foundational priority, and The Foundation is the foremost Canadian charity supporting kidney research. Since 1973 The Kidney Foundation research program has invested continuously to support kidney-related disease research in Canada. The Foundation prides itself on a stringent, high-quality research program which supports all areas of kidney research including projects focused on increasing education and advocacy efforts, population health and prevention studies, research on kidney donation and transplant, as well as projects developing novel treatments, concentrating on overall wellness, and finding a cure for kidney disease. The Foundation continues to be committed to excellence and is strategically focused on addressing patient and community driven priority areas with the goal of leading to an improvement in long term health and wellness for those with kidney disease and post kidney transplant. To help support life-changing research for the kidney community, go to www.kidney.ca.
The Kidney Foundation of Canada
Wendy Kudeba
Wendy.kudeba@kidney.ca
289-329-0757
