Author: ctourigny

Hamilton, ON, Canada and New York, NY – On October 3, 2023, Allarta Life Science, a Hamilton, Ontario-based regenerative medicine company announced it has received an award from JDRF International (JDRF Canada’s parent organization), that could amount to US$800,000 upon completion of research and development milestones.

Allarta was co-founded in 2019 by McMaster University Chemistry Professor Dr. Harald Stover and STEM leader Maria Antonakos, MBA, and uses polymer science and novel hydrogels to advance cell therapies for type 1 diabetes (T1D).

A large area of cure based T1D research is investigating cell therapy. The goal of cell therapy is to replace beta cells that are destroyed in a person with T1D, thereby allowing them to produce insulin again. This would lessen or eliminate the amount of external insulin required by someone living with T1D (either by injection, pen, or pump) for years or even decades.

One of the primary hurdles to cell therapies becoming a reality for people with T1D is the need for ongoing, systemic immunosuppression medication (similar to an organ transplant like a kidney or liver). To solve this problem, Allarta has developed a hydrogel platform that offers immune protection for transplanted beta cells. Allarta’s competitive advantage lies in its synthetic hydrogels designed to allow good metabolic connection of transplanted cells while protecting them from the hosts’ immune system.

The grant will directly fund Allarta’s ongoing work to increase durability and avoid the need for systemic immune suppression in current islet and beta cell transplantations to cure T1D. Pre-clinical studies will be conducted with porcine islets and stem cell-derived beta cells to determine if they can survive without immunosuppression.

“Protecting transplanted cells from immune rejection without the use of chronic systemic immunosuppression remains one of the primary barriers to the broad application of islet cell therapies to cure type 1 diabetes. Addressing it is a key priority for JDRF so that these therapies can be fully implemented,” said Jaime Giraldo, Ph.D., Associate Director of Research at JDRF International. “Allarta’s approach is well-aligned with our research strategy, and we look forward to working with them on testing the ability of these unique materials to protect implanted insulin-producing cells following transplantation.”

JDRF Canada is very excited to see a Canadian company as the recipient of this industry grant and one at the forefront of cutting-edge stem cell technology as a possible cure for type 1 diabetes. We will report on any results of the pre-clinical studies as they become available.

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About JDRF Canada  
JDRF Canada is the leading charitable organization funding type 1 diabetes (T1D) research in Canada. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, governments, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout Canada and five international affiliates are dedicated to advocacy, community engagement and our shared vision of a world without T1D. For more information, please visit jdrf.ca

Media Contact:  
Ruth Kapelus
National Content and Media Relations Manager, JDRF Canada 
T. 647.789.2322 
E. rkapelus@jdrf.ca 
235 Yorkland Blvd., Suite 1201 Toronto, ON M2J 4Y8 
jdrf.ca 

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Semaglutide, brand names Ozempic®, Rybelsus®, and Wegovy®, is all over the news. It is Health Canada-approved to help people with type 2 diabetes (T2D) manage their blood glucose levels. It also decreases the risk of cardiovascular events and helps with weight loss. According to a recent commentary published in the New England Journal of Medicine [subscription required] by investigators at the State University of New York at Buffalo, it may also help newly diagnosed individuals with type 1 diabetes (T1D) make more insulin.

What Is Semaglutide?

Semaglutide is a peptide similar to naturally occuring glucagon-like peptide (GLP-1). It helps people with T2D in various ways, including by stimulating insulin production. These drugs have been on the market since the early 2000s.

Thanks to decades of JDRF-supported research, we know that most people diagnosed with T1D still have some functioning beta cells. They no longer make the amount of insulin needed by the body to function, but they do exist.

Preserving those beta cells, keeping them healthy and alive and, eventually, increasing their number and function through disease-modifying therapies is one of JDRF’s key priority areas when funding research.

 Study Results

The researchers in this study, who currently receive JDRF funding (via JDRF International in the United States) to investigate the use of semaglutide later in disease to assist with glycemic control, administered the drug to 10 individuals. These individuals were between the ages of 21 and 39 in stage 3, or new-onset T1D. They began treatment with semaglutide within three months of diagnosis with the goal of preserving beta cell function. Nine individuals tested positive for GAD, an antibody which can indicate the presence of autoimmunity for T1D; one tested positive for IA-2, another T1D autoantibody. Over the course of several months, all 10 individuals no longer had to administer insulin at mealtimes and six of the participants no longer needed basal insulin after six months. Additionally, participants saw an increase in C-peptide, which shows that their bodies were making more insulin after being on the therapy.

What Comes Next

These results are exciting, but much more work is needed.

The study raises additional questions for researchers. What effect does using semaglutide to increase insulin production by the remaining beta cells have on these cells? It’s possible that it may add further stress to these cells. Researchers still need to determine what the effect of this stress will be beyond the length of this study. Will the beta cells continue to produce insulin or will insulin production decline as it does typically with T1D? All of this must be investigated in a larger, follow-up study with a control group.

GLP-1s Are a Priority for JDRF

JDRF has been a central player in the discovery and development of GLP-1s for decades,  and funded many studies to better understand this hormone, how it functions, and how it can be used to help people with T1D. JDRF believes semaglutide has tremendous promise to improve glucose control and mitigate heart and kidney complications for individuals in stage 4, or established T1D.

That work continues today. There are several JDRF-funded clinical trials to see how people with established T1D can benefit. This includes research led by Dr. Viral Shah at the Barbara Davis Center at the University of Colorado—and in collaboration with three other leading diabetes centers (Henry Ford Hospital, Iowa Diabetes, and the Oregon Health & Science University)—which is investigating ways semaglutide may benefit people with T1D and obesity who are using artificial pancreas (AP) systems.

There are currently no T1D semaglutide trials active in Canada.

These drugs are also being explored by the JDRF T1D Fund. T1D Fund portfolio company i2O Therapeutics is developing several products leveraging GLP-1s, initially for T2D, including a refillable, implantable GLP-1 device that delivers 6 months’ worth of the hormone, an oral form of long acting GLP-1, as well as a combined oral GLP-1 with Amylin (another important pancreatic hormone).

Additionally, Code Bio, a T1D Fund portfolio company, has explored GLP-1 to target beta cells for targeted drug delivery. 

JDRF Canada will continue to monitor results of GLP-1 studies and report on findings as they become available.

The JDRF Canada Emerging Clinician Research Award (ECRA) is designed to provide crucial support to investigators who plan to pursue a career in type 1 diabetes (T1D)-related clinical investigation. Awards are made in the late stage of training or early career to support the development of the awardee’s independent research program.  

These awards are given to clinicians who have demonstrated superior scholarship and show the promise for future achievement in clinical research, particularly in those areas that require the unique training of a clinical investigator. An important focus of these awards is the development of a patient-oriented research program and the mentorship of the awardee by an experienced clinician-scientist.

Dr. Alanna Weisman is a clinician-scientist and endocrinologist at the Leadership Sinai Centre for Diabetes in Toronto, Ontario and assistant professor in the Department of Medicine at the University of Toronto. She obtained her MD from Queen’s University, Kingston, Canada and her PhD in Clinical Epidemiology and Health Care Research from the University of Toronto.

Dr. Weisman’s research focuses on the use of diabetes technology (such as insulin pumps and continuous/flash glucose monitors) across Canada. Her primary focus is examining the rates of diabetes technology use among people from historically marginalized communities and identifying barriers to use that can be addressed.

Dr. Weisman is also leading studies of the real-world feasibility of recommended glycemic targets in type 1 diabetes and is examining the impact of government-funded insulin pump programs on the uptake of this technology in people with type 1 diabetes.

Dr. Weisman has published more than 40 primary research articles in peer-reviewed journals to date.
The award is $400K over four years and will support Dr. Weisman as a clinician-scientist. Her research will also have implications on JDRF’s Access for All program, which advocates both provincial and federal governments for greater access to diabetes devices and technology and more research funding for T1D.

JDRF had the chance to speak with Dr. Weisman to learn more about her research and how it will potentially impact people living with T1D.

What started your interest in type 1 diabetes? 

 What first sparked my interest was one of my mentors, Dr. Bruce Perkins. Early on when I was training to become an endocrinologist, I worked with Dr. Perkins on some of his research projects in type 1 diabetes and these experiences convinced me that I wanted to pursue a career as an endocrinologist and a researcher. I was drawn specifically to type 1 diabetes through my experiences in clinic seeing patients who live with type 1 diabetes. There were and continue to be many challenges for people living with type 1 diabetes that are unique to those of type 2 diabetes, and I felt there were many areas where we could improve.  

Can you please describe your current field of T1D research?

My research is currently focused on two major areas. The first area relates to the widespread recommendation that adults with type 1 diabetes meet a specific blood glucose target (a Hemoglobin A1c value of 7.0% or lower). I have been analyzing health care data in Ontario for large numbers of adults with type 1 diabetes to determine what are the trends in Hemoglobin A1c over time, and trying to understand the factors that drive this gap we see between what is being recommended and what actually happens in the real world. The second area is focused on understanding how technologies like insulin pumps or continuous glucose monitors are being used in Canada and how this relates to different funding policies for these devices. 

What are some of the existing barriers to diabetes technology in marginalized communities? 

 This has not been studied yet in Canada, and it is important to do so because of our unique health care system. In other countries, some of the barriers have been the costs of these devices, lack of access because of where someone lives or the type of diabetes team they see, or the devices not being recommended in the first place because of preconceived ideas about who would be able to use technologies or not.  

What novel interventions to improve outcomes for people living with diabetes do you foresee emerging from this research?
I believe our research will identify areas for improvement for governments, health care providers, and those living with type 1 diabetes. I hope we may see some policy changes to make technologies easier for all to access. I expect we will develop new tools and strategies for health care providers and patients that we can incorporate into clinics to increase awareness of the benefits of diabetes technologies and make them easier to use.  

On Monday July 11, 2022, Vertex Pharmaceuticals announced they acquired ViaCyte for $320 million in cash to help speed up the development of VX-880, Vertex’s stem cell-derived therapy for people with type 1 diabetes (T1D).

What does this mean for Canadians living with type 1 diabetes?

T1D is an autoimmune disorder where the body destroys the beta cells in the pancreas that produce the insulin hormone. People with T1D must administer external insulin, either through injection, pen or pump in order to survive. One of the pathways to cures for T1D is through beta cell replacement therapies that allow the body to start producing its own insulin again, limiting or ideally entirely removing the need for externally administered insulin.

What does this acquisition mean for type 1 diabetes beta cell replacement research?

Per the joint press release, this deal provides Vertex with access to ViaCyte’s:

• Complementary assets.
• Capabilities and technologies including additional human stem cell lines.
• Intellectual property around stem cell differentiation.
• Good Manufacturing Practice (GMP) manufacturing; and
• Access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.

Advancing beta cell research

This acquisition brings together the two highly innovative companies pursuing cell replacement therapies as a transformative and potentially curative approach for people with T1D.

Vertex and ViaCyte have been working independently to develop cell replacement therapies for people with T1D. This deal will allow them to combine their resources, technologies, and intellectual property, and position Vertex to move cures to market faster.

Both companies currently have in human clinical trials for the stem cell therapies. These require implantation of beta cells into the liver to see if they will encourage the body to start producing its own insulin again.

VX-880 is a “naked” cell therapy that requires the recipient to use immunosuppressive therapy, like other organ or tissue transplants. ViaCyte is testing two stem cell-derived replacement therapies and a CRISPR gene-editing technology for cell replacement that wouldn’t require immunosuppression after implantation.

What is JDRF’s role?

JDRF support has been crucial to getting to this point where both companies have cell replacement therapies in human clinical trials.

JDRF has provided long-time and significant support of ViaCyte through research funding. JDRF support includes the first ever clinical trial to test a stem cell-derived cell replacement therapy for T1D, in 2014.

Vertex’s phase I/II clinical trial of VX-880 was made possible by Dr. Doug Melton’s years of JDRF-funded research and an investment from the T1D fund in Semma Therapeutics—a biotech company founded by Dr. Melton to develop a stem cell-derived islet therapy for T1D—which was acquired by Vertex Pharmaceuticals.

JDRF and all its affiliates have been leaders in stem cell research and have collectively provided funding of over $150 million since 2000, as part of JDRF’s cell therapies program.

Additionally, the T1D Fund has aggressively invested alongside private venture capital firms in the beta cell replacement field.

As part of JDRF’s funding support to cure research, the goal has been to accelerate multiple approaches to cell therapies. Today, 50+ companies and research groups, including Vertex and ViaCyte, are advancing cell replacement development and cures with JDRF support and through the JDRF Beta Cell Replacement Consortium. Vertex’s acquisition of ViaCyte will ideally encourage other companies in this space to evaluate and modify their programs with the goal of finding cures faster.

Both ViaCyte and Vertex have clinical trials currently active in Canada, out of the University of Alberta and McGill respectively.

To learn more about JDRF funded clinical trials actively recruiting in Canada, please click here.

JDRF will continue to monitor the results of VX-880 and report back with updates as they become available.

The American Diabetes Association’s 82nd Scientific Sessions, were held from June 3-7 both in person and virtually. This annual conference brings together researchers and scientists to both present and learn about the latest in type 1 diabetes research and technological advancements. Many of the presenters are funded by JDRF International, JDRF Canada’s affiliate in the United States.

You can view all the oral and poster presentations on the Diabetes journal website.

Updates in cure-based research:

Stem Cell-Derived Beta Cell Therapy

 Vertex, ViaCyte and Sernova  are making exciting progress in the areas of stem cell derived beta cell therapy, and have all received JDRF funding at some point for their research.

Funding cell replacement therapies research is one of JDRF’s most critical undertakings globally, in its efforts to support the most promising cure-based research into type 1 diabetes (T1D). 

Vertex launched its clinical trial of VX-880, a stem cell-derived beta cell therapy in T1D, in combination with immunosuppressive therapy to protect the cells from rejection, in the summer of 2021. To date, three participants have received the therapy, and one is now insulin independent. ViaCyte, in partnership with CRISPR Therapeutics, initiated its first-in-human gene-edited, stem cell replacement therapy, without immunosuppression, called VCTX210.

Sernova provided an update on the phase I/II clinical trial of their Cell Pouch™—an implantable device designed to form a natural environment and allow the survival and function of insulin-producing (islet) cells. The first three individuals to receive the therapy into the Cell Pouch™, with a supplemental marginal dose of islet cells via the portal vein, have been insulin independent for 2 years, 6 months, and 3 months, respectively. JDRF continues to support Sernova to make their Cell Pouch part of the cure portfolio.

There were also presentations on clinical and preclinical data from several investigations on encapsulation and immune-tolerance strategies, including JDRF-funded James Shapiro, M.D., Ph.D. and Andrew R. Pepper, Ph.D., of the University of Alberta, Canada.

Disease-Modifying Therapies

T1D is caused by adaptive immune cells attacking and eventually killing the beta cells in the pancreas that are responsible for producing insulin – but beta cell stress and dysfunction precede the complete loss of cell function, and immune cells are responsible. The prohormone to islet amyloid polypeptide (proIAPP, for short)—as C. Bruce Verchere, Ph.D., and Rebecca Hull-Meichle, Ph.D., discussed in their presentations—is elevated prior to clinical diagnosis, in addition to proinsulin—the precursor to insulin. proIAPP, in turn, causes inflammation and innate immune cell damage.

Dr. Verchere has developed a test to measure two kinds of proIAPP in humans, which will ultimately provide new insight into beta cell function and pave the way for new therapies and biomarkers of beta cell stress. What does this mean? Potential medications or disease modifying therapies could be brought to market that could slow or stop the immune response responsible for killing the beta cells.

Dr. Verchere received a JDRF postdoctoral fellowship beginning in 1992 and Dr. Hull-Meichle received one in 2001-2003.

Dr. Verchere is now leading the JDRF Center of Excellence at the University of British Columbia, where he is working on immune and beta cell therapies, including stem cell-derived therapies, with Dr. Kieffer; James Johnson, Ph.D., who received a JDRF Career Development Award in 2005-2010; Francis Lynn, Ph.D., who was a JDRF postdoc from 2004-2006, advanced postdoc from 2007-2009, and a JDRF Alan Permutt Career Investigator from 2012-2016; and Megan Levings, Ph.D., who has received two JDRF grants since 2015 and has been a mentor to two JDRF postdocs.

Type 1 Diabetes Screening in the General Population

As a result of decades of JDRF-funded research, it is now possible to identify those at highest risk for developing T1D—those who have two or more autoantibodies present in people with type 1 diabetes.

Several JDRF-funded researchers presented on the current state of screening for both genetic risk and/or T1D-related autoantibodies. Chantal Mathieu, M.D., Ph.D., gave a talk about why it’s time to screen for T1D in the general population. She emphasized that T1D is a serious disease and that decreasing the incidence of diabetic ketoacidosis (DKA) a potentially life-threatening complication that is often the first sign of T1D in individuals – is cause to warrant population screening.

Post-screening, healthcare practitioners must be available for follow-up and guidance so families know what to do with autoantibody status, including potentially enrolling in clinical trials of disease-modifying therapies like teplizumab, a drug that may slow the development of T1D before DKA. Screening will help identify populations who can benefit from these therapies.

Screening is now a priority of the JDRF-CIHR Partnership to Defeat Diabetes, as it’s seen as a path to a cure by developing disease-modifying therapies to keep the disease from progressing and, ultimately, prevent it entirely.

Improving Lives

Artificial Pancreas Technologies

There were multiple presentations on the ‘artificial pancreas’, or automated insulin delivery (AID), systems.

Some presentations highlights included the results from the first randomized clinical trial testing of a do-it-yourself, or DIY, open-source, community-built AID technology, using the OpenAPS algorithm plus the DANA or YpsoPump insulin pump and the Dexcom G6 continuous glucose monitor (CGM).

The study included 100 children and adults in New Zealand who used the DIY system compared to those without the algorithm, headed by JDRF International grantees Martin de Bock, Ph.D. (who also gave the presentation), and Dana Lewis, the founder of the DIY artificial pancreas system movement. There was no severe hypoglycemia and no DKA, and more participants achieved time-in-range of ˃70% using the OpenAPS algorithm, especially at night.

As well, there was a presentation on the results from a randomized insulin-only iLet bionic pancreas pivotal trial. These were presented by Steven Russell, M.D., Ph.D., at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in April 2022, but now we have reports from the participants, presented by Jill Weissberg-Benchell, Ph.D., a professor at the Ann & Robert H. Lurie Children’s Hospital of Chicago. The study included adult participants who reported decreased distress, with less burnout due to increased time-in-range and no need to carbohydrate count, and youth who reported positive experiences, including improved A1c, increased independence, and less time managing diabetes.

Diabetic Retinal Disease

Sobha Sivaprasad, M.D., reported on The Restoring Vision Moonshot, an approach to ending diabetic eye disease. The Early Treatment Diabetic Retinopathy Study (ETDRS) Scale was developed in the 1950s but was limited to point-in-time visual perception.

Dr. Sivaprasad is part of 50 global experts who will review the literature on diabetic eye disease in the next year, to develop an evidence-based updated retinopathy staging scale, creating recommendations that will incorporate decades of progress in functional imaging, other biomarkers, and metrics of quality of life. When this scale is completed, it will lead to the development of early preventive therapies to reduce vison-threatening retinopathy progression, and ultimately improve quality of life for people with T1D.

It’s an exciting time in type 1 diabetes research. JDRF will continue to monitor these studies and provide further updates as they become available.

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In collaboration with CIHR, JDRF Canada has recently announced a major funding opportunity in the area of screening for T1D risk. Here, we explain the reason why screening for T1D risk is central to our quest for cures. 

Researchers use the word ‘cures’ deliberately, as there are many pathways to a world free from T1D. One such path is screening and prevention – catching the disease before the onset of clinical symptoms. T1D is an autoimmune disease, where the body attacks the beta cells in the pancreas responsible for producing insulin. The key to protecting beta cells is to discover this autoimmune response early enough to slow it down or halt it entirely. 

Universal screening offers the potential to identify people who are at risk of developing T1D. Canada has one of the fastest growing rates of T1D diagnoses anywhere in the world – and we don’t know why. The more we screen people, the greater the likelihood of unlocking the mechanisms behind the development of the disease. 

JDRF-funded research previously discovered that the presence of two or more specific markers indicative of an autoimmune response to the pancreas – called autoantibodies – indicates that a person is almost 100% likely to develop T1D in their lifetime. Screening also provides the opportunity to educate those at risk about the signs and symptoms of T1D and provide supportive follow-up, preventing the life-threatening complication diabetic ketoacidosis (DKA) at diagnosis. Finally, we know that while first-degree family members of T1D are at an elevated risk of developing T1D, around 85-90% of newly diagnosed cases do not have a direct family connection. 

It’s not just about preventing DKA.  

The prevailing medical wisdom used to be that T1D developed quickly, with a sudden onset of symptoms including thirst, hunger, increased urination, weight loss, and fatigue. Thanks to advances in screening and a better understanding of the human immune system, we now know that T1D does not develop suddenly but in fact the disease process usually starts long before insulin is required. 

Once the immune system begins to attack the insulin-producing cells in the pancreas, we can detect markers in the blood (autoantibodies) that tell us a person is at increased risk. This is because the disease is otherwise asymptomatic or silent earlier on. 

T1D happens in 3 stages: 

Because most people do not have a family history of T1D, symptoms and a diagnosis often come out of the blue. In 25-45% of diagnoses in children in Canada, this unexpected diagnosis comes with DKA, a serious and life-threatening complication that can lead to death if not treated promptly. People with T1D know what to do to minimize the risk of DKA and to seek medical attention if it occurs—but people who have yet to be diagnosed do not. That’s why, unfortunately, a significant percentage of people experience DKA at diagnosis and require hospitalization.  

To avoid this risk, everyone that wants to should have the opportunity to get tested for T1D autoantibodies. If a positive result is found, families could develop a plan for further monitoring with their doctor to avoid serious complications and lower the risk for life-threatening DKA at diagnosis. The hope is that in the future, there may be therapies that allow healthcare professionals to intervene and delay or even prevent T1D onset.  

How to Get Screened 

Currently, only family members of people with T1D can be screened for T1D risk through TrialNet. TrialNet is an international network of leaders in T1D research and clinical care with centers in the United States and internationally. A key goal of JDRF’s global research strategy is to support research that enables introduction of general population screening to identify high-risk individuals for early detection, reduce DKA at diagnosis, and accelerate the evaluation of disease-modifying therapies that could delay or prevent the disease. 

What’s Next for Screening in Canada? 

Now, JDRF Canada is pleased to announce a new funding opportunity in the area of T1D screening in partnership with the CIHR Institute of Nutrition, Metabolism and Diabetes. The goal of the CIHR-JDRF Type 1 Diabetes Screening Research Consortium is to develop a single nationally coordinated research network to explore key research questions about the feasibility and acceptability of a general population T1D screening program in Canada, building on experiences from other countries.  

Most T1D screening studies have up to now focused only on family members. However, as 90% of people diagnosed with T1D do not have any family history, family-based screening does not identify most people at risk. This new funding opportunity looks to address this gap and help us better identify why T1D develops in Canadians, with potential benefits globally. As well, it will help advance research into potential disease-modifying therapies that could be applied at the moment high risk is identified in an individual. 

Stopping T1D before it starts is the ultimate goal, and a universal screening program will be essential to prevent new diagnoses of this disease in the future. 

We strongly encourage you to consult with your or your child’s physician for input as you make decisions about screening for T1D risk. Considering various sources of expert guidance and that from one’s own physician is the best way to make personal health choices. 

A focus of JDRF’s Improving Lives research is to improve glucose control and reduce the burden of self-management by advancing the development of new drugs and devices for people with type 1 diabetes (T1D).

The study: Can adding an approved glucose-lowering drug to treatment with a closed-loop insulin delivery system improve glucose control in T1D?

A JDRF funded collaborative team out of Mount Sinai Hospital and McGill University recently published findings in Nature Medicine about how an add-on treatment to insulin could improve glucose control in adults living with T1D. Empagliflozin is an already approved medication that is used to improve blood glucose levels in people living with type 2 diabetes.

Dr. Bruce Perkins and Dr. Ahmad Haidar, alongside their teams at the Research Institute of the McGill University Health Centre and the Lunenfeld-Tanenbaum Research Institute in Toronto, examined the individual and combined efficacy of the SGLT2 inhibitor empagliflozin – an oral drug that acts on the kidney to rid the body of excess glucose – on the time spent in the glucose target range (3.9-10.0mmol/L) over a 4-week period in people living with T1D. Participants in the study took empagliflozin while using either a closed-loop system or a sensor-augmented insulin pump. The study was placebo-controlled, meaning that some participants did not receive the drug and no participants knew which one they were being administered.

What did the study find?

Empagliflozin improved the time in range whether participants were using the closed-loop system (by 7.2%) or the sensor-augmented insulin pump (11.4%), and also decreased daily insulin doses. Compared with participants who used an insulin pump alone, participants who used a closed loop system plus empagliflozin spent 17.5% more time in range each day (i.e., over 4 hours). As per international consensus guidelines, an increase of the glucose target range of more than 5% is considered clinically meaningful. Since empagliflozin can increase the risk of ketoacidosis in people with T1D, the team also closely monitored daily ketone levels. Although ketone levels were higher in some participants, the researchers observed no episode of diabetic ketoacidosis (a hyperglycemic episode that requires immediate medical attention) with empagliflozin in this study. There were also no episodes of severe hypoglycemia.

What does this mean for people with T1D?

The addition of adjunct therapy to T1D management and especially closed-loop systems holds a lot of promise. Drugs like empagliflozin may also have protective benefits for the heart and the kidneys in people with T1D, and previous studies have shown that the drug can improve HbA1c, weight and blood pressure without increasing hypoglycemia.

What comes next?

Further research is needed with this drug and with other adjunct therapies for people living with T1D –as insulin alone is often not sufficient to help these individuals reach their target blood glucose goals and new therapies offer opportunities to reduce management burden. JDRF will continue to fund the most promising research into drug therapies, and partner with regulators to accelerate approvals, with the aim of driving those that show the greatest promise to market as quickly as possible.