Long-term islet transplant recipients show near-normal glucose control

FOR IMMEDIATE RELEASE:

Continuous glucose monitoring demonstrates improved time-in-range, key metabolic data compared to hybrid closed-loop systems

Diabetes Research Institute Foundation

Continuous glucose monitoring (CGM) evaluations in islet transplant recipients who have been insulin independent for an average of 10 years show near-normal glycemic profiles and time-in-range metrics, according to data presented by the Diabetes Research Institute at the University of Miami Miller School of Medicine. The findings, which were accepted as a late-breaking poster at the American Diabetes Association (ADA) 79th Scientific Sessions, June 7 – 11, 2019 in San Francisco, CA, demonstrate that islet transplantation can be a successful long-term cell therapy for select patients with type 1 diabetes.

The DRI team evaluated five of its adult subjects who received intrahepatic (in the liver) islet transplants between 2002 – 2010 and have since remained insulin independent for seven to 16+ years. During their last study follow-up, the subjects completed a 7-day, non-blinded CGM to assess their glycemic profiles. Compared to current recommended CGM goals for adults with type 1 diabetes on a hybrid closed-loop system, all patients demonstrated improved CGM time-in-range, reduction in glucose variability, and prevention of hypoglycemia. A sampling of the results is as follows:

CGM Glucose Range CGM % Time-in-Range recommended goals for hybrid closed-loop system CGM % Time-in-Range in DRI islet transplant subjects with long-term insulin independence
(mg/dL)
70-180 ≥70 96.4
<70 ≤3 0.9
<54 ≤1 0.1

In addition, time in the more stringent glucose range of 70-140 mg/dL was 83.1%, with a mean sensor glucose (SG) value of 116 mg/dL and an average HbA1c of 5.7%. The ADA’s recommended HbA1c goal is <7% for adults with diabetes.

“Using continuous glucose monitoring, we now have the ability to accurately evaluate patients’ glucose profiles and their variability. The CGM data we have obtained from our islet transplant patients clearly demonstrates that islet transplantation can result in glucose levels that are close to those in people who do not have type 1 diabetes, even 10 years or more after undergoing the cell-replacement procedure,” said David Baidal, M.D., assistant professor of medicine and member of the DRI’s Clinical Islet Transplant Program. One of the principal investigators of the study, Dr. Baidal is presenting the results at the ADA conference.

“Although not all subjects remain insulin independent, like the subjects described in this presentation, after an islet transplant a significant number of them continue with excellent graft function for over 10 years that allows them to have near-normal glucose metabolism in the absence of severe hypoglycemia on small doses of insulin,” said Rodolfo Alejandro, M.D., director of the Clinical Cell Transplant Program and also a principal investigator of the study. Dr. Alejandro will be presenting these results at the upcoming 17th World Congress of the International Pancreas & Islet Transplant Association, July 2-5, 2019 in Lyon, France.

“This report confirms the superiority of transplantation of insulin-producing cells compared to insulin therapy, with glucose control results that were even better than the goals of CGM in hybrid closed-loop systems. Hopefully, this will be of assistance in bringing islet transplantation closer to FDA approval, allowing the treatment to be made available to U.S. patients, as has already been the case in several other countries, for many years,” said Camillo Ricordi, M.D., Stacy Joy Goodman Professor of Surgery and director of the Diabetes Research Institute, who was recently named the world’s leading expert in islet transplantation by Expertscape. Dr. Ricordi is well-known for inventing the machine (Ricordi Chamber) that made it possible to isolate large numbers of islet cells from the human pancreas and for performing the first series of successful clinical islet transplants that reversed diabetes after implantation of donor purified islets into the liver of recipients with diabetes.

In type 1 diabetes, the insulin-producing islets cells of the pancreas have been mistakenly destroyed by the immune system, requiring patients to manage their blood sugar levels through a daily regimen of insulin therapy. Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants have been insulin independent for more than a decade, as DRI researchers have published. Currently, islet transplantation remains an experimental procedure limited to a select group of adult patients with type 1 diabetes.

In 2016, the National Institutes of Health-sponsored Clinical Islet Transplantation Consortium reported results from its Food and Drug Administration (FDA)-authorized Phase 3 multi-center trial, of which the DRI was a part, indicating that islet transplantation was effective in preventing severe hypoglycemia (low blood sugar levels), a particularly feared complication in type 1 diabetes that can lead to seizures, loss of consciousness and even death. The study was a significant step toward making islet transplantation an approved treatment for people with type 1 diabetes and reimbursable through health insurance, as it is in several other countries around the world.

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About the Diabetes Research Institute

The Diabetes Research Institute at the University of Miami Miller School of Medicine leads the world in cure-focused research. As one of the largest and most comprehensive research centers dedicated to curing diabetes, the DRI is aggressively working to develop a biological cure by restoring natural insulin production and normalizing blood sugar levels without imposing other risks. Researchers have already shown that transplanted islet cells allow patients to live without the need for insulin therapy. Some study participants have maintained insulin independence for more than 10 years. The DRI is now building upon these promising outcomes through its BioHub strategy, a multidisciplinary, three-pronged approach for addressing the major challenges that stand in the way of a cure: eliminate the need for anti-rejection drugs, reset the immune system to block autoimmunity, and develop an unlimited supply of insulin-producing cells. For more information, please visit DiabetesResearch.org, call 800-321-3437, or Tweet @Diabetes_DRI.

Soliqua®Phase 3 results significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments

Soliqua®Phase 3 results significantly lowered blood sugarlevels compared to GLP-1 receptor agonist treatmentsPatients switched to Soliqua reached anaverage blood sugarbelowthe American Diabetes Association recommendedlevel of 7%FullPhase 3 data presentedtodayat the American Diabetes Association(ADA)79th Scientific Sessions PARIS–June 9, 2019–In a Phase 3 study1evaluating adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments, Soliqua®/Suliqua®2(insulin glargine 100 Units/mL and lixisenatide) met the primary study objectivebydemonstrating astatistically superior reduction of average blood sugar level (HbA1c)after26weeks, compared with continuing GLP-1 RA treatment.The LixiLan-G study included either a daily or once-weekly GLP-1 RA treatmentas comparator. Morepatientswho switched to Soliqua achieved HbA1clevelsbelow 7%, a target recommended by the ADA, compared with those who stayed on previous GLP-1 RA therapy. More patients who switched to Soliqua also achieved the composite endpoint of HbA1cbelow 7% without documented symptomatichypoglycemia(low blood sugar levels).The study showed a safety profile consistent with the established profiles of the treatments studied: the most common classes of adverse event were gastrointestinal events (i.e., nausea, diarrhea and or vomiting) and hypoglycemia.1Blonde L et al, Presentation #149 OR, American Diabetes Association 79th Scientific Sessions, June 9, San Francisco, CA, U.S.2Soliqua®is an injectable prescription medicine that contains two diabetes medicines, insulin glargine and lixisenatide.Soliqua®is marketed in the EU as Suliqua®, where it is indicated in combination with metformin for the treatment of adults with type 2 diabetesmellitus to improve glycemic control when this has not been provided by metformin alone ormetformin combined with another oral glucose lowering medicinal product or with basal insulin. It is marketed in the U.S. as Soliqua®100/33, where it is indicatedas an adjunct to diet and exercise to improve glycemiccontrol in adults with type 2 diabetes mellitus.It is marketedas Soliqua®in other geographies where it is approved

The full Phase 3 data results were presented today for the first time as an oral presentation at the 79thScientific Sessions of theADAin San Francisco.“We are committed to providing people living with diabetes a broad range of options thatcan help support personalized care,”said Rachele Berria, Global Head of Diabetes Medical Affairs at Sanofi. “As the first comparison between Soliqua and both daily and weekly GLP-1 RA treatments, this study provides physicians with new data that they could use when consideringSoliqua as a part of a personalizedtreatment plan.”About the studyThe LixiLan-G study included 514 adults with type 2 diabetes who were inadequately controlled on a GLP-1 RA (either once-daily liraglutide or twice-daily exenatide, or once-weekly exenatide extended release, albiglutide or dulaglutide) and metformin (with or without pioglitazone, with or without a sodium-glucose transport protein 2 inhibitor [SGLT2i]).Participants were randomized to either switch to Soliqua or continue theirprevious GLP-1 RA treatment, while maintaining their other pre-trial anti-diabetic medication. Adherence to allocated treatment was monitored and reinforced throughout the study.The primary objective was to demonstrate superior reduction of HbA1cwith Soliqua versus continuation ofthe previousGLP-1 RA after 26 weeks. Secondary objectivesincludedcomparison of the overall efficacy and safety ofSoliqua to continued GLP-1 RA treatment. After 26 weeks, patients who switched to Soliqua saw a 0.6% greater reduction in HbA1cversus continuing treatment with a GLP-1RA:SoliquaGLP-1 RAMean HbA1cat baseline7.86%7.88%Mean HbA1cat Week 266.7%7.4%Reduction in HbA1c-1.02%-0.38%Least squares mean difference-0.64%95% Confidence interval-0.77to -0.51p-value<0.0001More patients who switched to Soliqua achieved HbA1cbelow the 7%target recommended by the ADAversus those treated with GLP-1RA(difference: 36%, p<0.0001).The study also evaluated compositetargets

of HbA1cbelow 7% without documented symptomatic hypoglycemia(<54mg/dL or ≤70mg/dL, respectively):SoliquaGLP-1 RA% of patientsachieving HbA1c< 7%62%26%% of patients achieving HbA1c<7% with no documented (≤70 mg/dL) symptomatic hypoglycemia43%25%% of patients achieving HbA1c<7% with no documented(<54 mg/dL) symptomatic hypoglycemia57%25%The study showed a safety profile consistent with previous studies:22% of patients who switched to Soliqua experienced gastrointestinal events (nausea, diarrheaor vomiting), compared with 10% of patients who continued previoustreatment with GLP-1 RA. Rates of hypoglycemiawere also consistent with the established safety profiles of thetreatments: 9% of patients who treated with Soliqua experienced at least one event, compared with <1% who remained on previous GLP-1 RA therapy.Participants treated with Soliqua were followed for a further 26 weeks. Data from this extension period will be presented at a later date.About SanofiSanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.Sanofi, Empowering LifeMedia Relations ContactAshleigh KossTel.: +1 908-981-8745Ashleigh.Koss@sanofi.comInvestor Relations ContactGeorge GrofikTel.: +33 (0)1 53 77 45 45ir@sanofi.comSanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actualresults and developments to differ materially fromthose expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or

government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, includingfuture clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements.

Up for the Challenge, Down for the Cause: Grace for the Cure!

Fundraising to End Type 1 Diabetes

Team “Grace for the Cure” is Up for the Challenge and Down for the Cause!

 

 

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Support Team Gracie Sevilla

 

 

Support Team Grace for the Cure!

 

Our team is participating in walks to end type 1 diabetes (T1D). The JDRF One Walk is one of many that we will participate in this year and we seek to also promote and support other reputable organizations, as well.

 

What’s in the World is Going On with Gracie?!

 

In March of 2018, our little Gracie was not her normal self. Her dad noticed her waking up several night in a row, late at night, to use the restroom and asking for something to drink as she was always “very thirsty”. Knowing a little something about Diabetes, her dad feared the worse and began to research and learn what he had been already fearing. He sent a link to his wife, who was fast asleep at the time and she was in denial. As the weekend approached, they knew they had to make an appointment with the doctor. Gracie’s Mom Melodie, was too distraught to call her Husband Tommy that morning, so one of his daughters had to, telling him to get down to the doctor’s office immediately, as it was certain Gracie was now a Type 1 Diabetic and they all needed to be trained to manage this deadly, life-long illness.

 

“It was not because of his sins or his parents’ sins,” Jesus answered. “This happened so the power of God could be seen in him.

John 9:3

 

So many questions were asked and so much was immediately learned; Type 1 Diabetes is not caused by eating too many sweets, a poor diet or being obese, but is rather an Autoimmune Disease whereby the Insulin producing pancreas shuts down for one reason or another, mostly likely the latent effects of having been afflicted with a virus long, or not long ago.

 

 

When you have T1D, your body stops producing insulin—a hormone essential to turning food into energy. Managing the disease is a constant struggle that involves monitoring your blood-sugar level, administering insulin, and carefully balancing these insulin doses with your eating and activity just to stay alive.

 

 

Gracie Sevilla – Type 1 Super Star!

We live by faith in Jesus Christ and lean not upon our own understanding, but rather trust Him in all things. Although sometimes it’s so much easier said then done, ultimately, we trust in Him and love Him so much. This being said, he’s blessed Gracie’s dad as a provider for his family and also with great determination and zeal for good things and causes; we feel ashamed at not knowing the struggles that so many dealt with before this came into our lives and we’re determined to overcome this daily with joy and live lives as normal as possible, using our talents and resources to the glory of God the Father; helping as many as possible and also helping to fund a cure.

Even with insurance this is an exceedingly expensive disease but where God guides, God provides and if we can bring awareness and also give to others in need like we have, awesome!

 

 

 

With T1D there are no days off and there is no cure. But there is hope.

 

 

 

YOU CAN HELP TOO!

Donate Directly to the Team and to Gracie and Her Needs

 

We trust in God and do not rely upon anyone but Him but we know full and well he works through others through prayers and giving from their hearts. Even as He has always supplied our needs abundantly and faithfully, there are those who love Gracie and know the struggle of this disease and want to help and therefore, want to donate to the Team itself, for Type 1 Diabetes extraordinary needs, in addition to or in place of the organizations that we support. For this reason, we have created donation buttons and the means to support, below.

 

 

However, know that if God hears your prayers, we cherish your prayers MOSTLY, but like some want to help Team Grace for the Cure monetarily, for this event and others upcoming, your gift on this site will:

Go directly to her special fund for events and other extraordinary needs; such needs are things like:

  • Attending special camps for Kids with Type 1 Diabetes, where the staff are either Type 1 themselves or highly trained and equipped. Gracie, only recently met another kid with Type 1 Diabetes in July; he, too, had a Dexcom g6 monitoring device, and it’s important for her to feel like she’s not alone, hence, our participation in these events organizing support teams and such;
  • 24 hour Glucose monitoring (Dexcom g6 sensors, for example, cost about $500 each and last only 10 days). Although we’ve been approved and have paid for a Dexcom g6 and have finally gotten insurance to cover it, there are always issues, limited supplies and red tape, forcing a lot of high, out of pocket expenditures;
  • Glucose Pump (something we are considering at the moment);
  • A specially trained Diabetic alert (service) dog that we are strongly considering at the moment. These dogs are specially trained and raised as pups in just a few places across the country and range from $10,000 and up. They can literally alert a glucose level drop or spike 15 minutes before it happens.

Things like this.

 

 

A Puppy for Gracie?

 

Your gift will go toward these things and will also go toward funding self-promoted future events, as we use our talents and resources to fight this disease to the benefit of ALL who suffer, especially the kids, with Gracie’s upcoming website (below). The direct gifts in the future will be tax-deductible:

www.GracieT1dSuperStar.org

You may donate using the Pay Pal buttons below, which will give you the option of paying by credit card or Pay Pal at checkout. If you’d like to increase the donation, simply change the quantity of the item at check out.

We thank you for your time and consideration and support.

 

 

$20 Donation to Help Fund Team: Grace for the Cure

$50 Donation to Help Fund Team: Grace for the Cure

$75 Donation to Help Fund Team: Grace for the Cure

$100 Donation to Help Fund Team: Grace for the Cure

 

 

To give directly to the JDRF, simply click on the link below!

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gracie sevilla t1d superstar

Walk for a Cure for Type 1 (Juvenile) Diabetes: Support Gracie Sevilla’s TEAM GRACE FOR THE CURE!

Type 1 Diabetes Fundraiser – Team Grace for the Cure

 

 

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Sevilla Local Media

Support Team Gracie Sevilla

Support Team Grace for the Cure!

Our team is walking to end type 1 diabetes (T1D).

When you have T1D, your body stops producing insulin—a hormone essential to turning food into energy. Managing the disease is a constant struggle that involves monitoring your blood-sugar level, administering insulin, and carefully balancing these insulin doses with your eating and activity just to stay alive.

With T1D there are no days off and there is no cure. But there is hope.

To Donate to the Event, with your 100% tax-deductible donation going directly to the Juvenile Diabetes Research Foundation (JDRF), please do so here by clicking the logo button at bottom or, if you wish to donate to Gracie’s team – Grace for the Cure – directly, please continue to read on …

or,

Donate Directly to the Team and to Gracie and Her Needs

There are those who want to see their donations go to the Team itself for the event(s) and to Gracie herself, directly. For this reason, we have created this page and the means to support, below.

We cherish your prayers and if you would like to help Team Grace for the Cure for this event and others upcoming, your gift on this site will:

  • Go directly to her for to fund the team for this event and others;
  • As well as for things like special camps for Kids with Type 1 Diabetes;
  • 24 hour Glucose monitoring;
  • Glucose Pump;
  • Even possibly, a specially trained Diabetic alert (service) dog that we are considering;

Things like this.

Your gift will also go toward funding self-promoted future events, as we use our talents and resources to fight this disease to the benefit of all who suffer, especially the kids, with Gracie’s upcoming website:

www.GracieT1dSuperStar.org

You may donate using the Pay Pal buttons below, which will give you the option of paying by credit card or Pay Pal at checkout. If you’d like to increase the donation, simply change the quantity of the item at check out.

We thank you for your time and consideration and support.

 

 

$20 Donation to Help Fund Team: Grace for the Cure

$50 Donation to Help Fund Team: Grace for the Cure

$75 Donation to Help Fund Team: Grace for the Cure

$100 Donation to Help Fund Team: Grace for the Cure