Category Archives: Diabetes

Eli Lilly is paying $55 million upfront for the rights to KeyBiosciences pipeline of treatments for Type 2 diabetes and other metabolic conditions. The agreement gives Lilly the global rights to phase 2 synthetic peptide dual amylin and calcitonin receptor agonist KBP-042 and other programs.

Lilly is handing over $55 million upfront and committing to an undisclosed amount of milestones for the rights to KBP-042 and follow-up assets. The earlier-stage assets have advanced no further than phase 1. KeyBioscience designed these drugs, which include BP-089 and KBP-056, to have the same broad mechanism of action as KBP-042 but deliver different effects or potency because of changes totheir engineering.

KeyBioscience has high hopes for the mechanism of action.

"We are extremely excited about the promise of this new mechanism, which could potentially improve insulin sensitivity, reduce weight and improve blood glucose control," KeyBioscience chairman Morten Karsdal said in a statement.

The range of improvements targeted by KeyBioscience reflects its assets dual targets. Amylin is the target of AstraZenecas Symlin, a drug research has linked to reductions in insulin-induced weight gain and the regulation of glucose excursions after eating. Calcitonin is less well established as a target of metabolic disease drugs but KeyBioscience has preclinical data to back up its belief in the dual agonist approach.

The novel dual agonist approach could give Lilly an edge over its rivals in the fierce fight for the diabetes market. Lillys competitors are also working on drugs that help diabetics manage multiple aspects of the disease and their comorbidities. Sanofi, for example, penned a deal worth up to 250 million ($281 million) with Exscientia last month to develop bispecific small molecules. These molecules could manage glucose levels while also helping patients to control their weight.

KeyBioscience has similar aspirations for its assets. The biotech was created by Danish CRO Nordic Bioscience to develop a family of metabolic peptides. Since then, it has generated preclinical data and pushed its lead candidate into phase 2 while also working with Enteris BioPharma on oral formulations of its peptide pipeline candidates.

That platform enabled KeyBioscience to attract the interest of Lilly. KBP-042 will slot into Lillys mid-phase diabetes pipeline alongside ultra-rapid insulin prospect LY900014.

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Lilly pays $55M for rights to KeyBioscience's diabetes assets - FierceBiotech

This August, Stephanie and Michael Honig of Honig Vineyard and Winery will host a special party on their property in Rutherford to raise money for a nonprofit diabetes organization called Beyond Type 1.

The party at Honig is just one stop on an epic, 10-week adventure for Team Bike Beyond, a cycling team composed of 20 international riders living with Type 1 diabetes. As they pedal their way from New York City to San Francisco, they will spread the word about Type 1 while showing the world what it means to live Beyond Type 1.

The event at Honig Vineyard and Wineryon Aug. 9 at 6 p.m. will raise money and awareness for Type 1 Diabetes.

Musician Nick Jonas, Juliet de Baubigny, Sarah Lucas and Sam Talbot founded Beyond Type 1 in 2015, and 100 percent of every dollar raised directly supports the most promising global efforts and programs working to educate, advocate and cure Type 1 diabetes.

Type 1, which affects more than 420 million people globally, is an autoimmune disease that can happen to anyone, can present at any age, and is not related to diet or lifestyle. The Honigs oldest daughter, Sophia, who recently turned 10, was diagnosed with Type 1 at the age of 5, changing the family dynamic forever.

No parent should ever be told that their child has a life- threatening, incurable disease. We will continue to do everything in our power until a cure is found, said Stephanie Honig.

Rep. Mike Thompson said, The Honigs have been tireless advocates for Sophia and the millions of other children and families living with Type 1 diabetes. Their efforts are more important than ever as federal funding for medical research comes under attack.

On the afternoon of the event, the Napa County Sheriffs Office, along with county officials, will escort and welcome the 20 bike riders into Napa County.

There are 11 restaurants hosting food stations: Brasswood, Brix Restaurant, Charlie Palmer, The Cliff Familys Bruschetteria, Crisp Kitchen and Juice, Elaine Bell Catering, Heritage Eats, Model Bakery, Mustards Grill, Oakville Grocery and Prabh Indian Kitchen.

Wine will be provided by Honig Vineyard and Winery, Beran, Dutch Henry, Jordan, Luna, St. Supery and Vineyard 29, with cocktails from Charbay. Music for the event will be provided by Groovetronix Productions. Classic Party Rentals is donating all of the party equipment, furnishing and supplies.

Sponsors of this event include Darioush, Trinchero Family Estates, Breakthrough Beverage Group, Chuck Wagner from Caymus Family Wines, David Drucker from Empire Merchants, St Helena Hospital, The Rudd Foundation, American AgCredit, Jelly Belly Candy Company, Jamie Kurtzig and Family, Nomacorc/Vinventions.

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Honig family planning diabetes fundraiser - Napa Valley Register

Innovation in diabetes seems to have reached a plateau, with recently launched drugs focusing on combinations and quick- or extended-action formulations. Sanofi's (NYSE:SNY) recent collaboration with private UK group Exscientia is taking drug discovery in a different direction - identifying bispecific small molecules that could work on multiple novel and known pathways.

The collaborators are taking the view that diabetes is not a standalone disorder, with accompanying conditions such as heart disease or obesity offering an opportunity to target mechanisms that work in conjunction with blood-sugar modulation. "We wanted to think about the next generation of diabetes treatment, not just about new pathways - but not just doing fixed dose combinations, and using a single molecule," Exscientia's chief executive Andrew Hopkins tells EP Vantage.

Finding faster

The deal, valued at a total of 250m ($280m), will see Exscientia identifying potential candidate molecules based on chemical compatibility and biological relevance, with research funding provided by Sanofi. The pharma giant will conduct assays, preclinical experiments and clinical trials upon exercise of a licence option on specific molecules.

Exscientia says its artificial intelligence-driven drug discovery platform allows for candidate generation in roughly a quarter of the time of traditional approaches. That will come in handy for Sanofi, for which 2017 will be the last year at the top of the diabetes heap as its long-acting insulin Lantus succumbs to generic competition.

The French group has sought to remain a player, in-licensing agents from Lexicon and Hanmi, though with the exception of a type 1 diabetes vaccine most of its collaborations have involved candidates in classes with well-established competition.

Thus the Exscientia deal represents a strategic shift of sorts, embracing small molecules and novel approaches to treating the condition, and taking a broader view that diabetes is one of a "cluster of morbidities", Mr Hopkins says.

"This potentially opens up ways of segmenting the market and coming up with medicine for these potential comorbidity options," he says. "It fits into the emergent thinking within both companies."

Obesity and non-alcoholic steatohepatitis are two comorbidities Mr. Hopkins names, but of course cardiovascular and kidney disease, chronic obstructive pulmonary disease and retinopathy are all complications of diabetes.

As for targets, some may be novel and some well-known, he says: "For some of the innovative targets that have come along and potentially have not shown as much efficacy as one would like, bootstrapping them with a validated target is an approach."

Immuno-oncology

Sanofi is the first big pharma name to show interest in Exscientia's work, but it is not the private group's first collaboration. Exscientia already handed over to Sumitomo Dainippon Pharma one bispecific molecule that selectively activates two G protein-coupled receptors from two distinct families in central nervous system disorders.

And it is working with Evotec on bispecific small molecules focusing on cancer-related adenosine targets with a role in immuno-oncology. At the AACR meeting in April, the partners presented early data on an agent that can antagonise adenosine 2A and CD73.

In oncology, Mr Hopkins believes that small molecule bispecifics might offer a cost-effective alternative to, for example, checkpoint inhibition antibodies used in combination with chemotherapies or other treatment approaches, or emerging cell and gene-based therapies.

Exscientia is now owned by its founders and staff, and has funded expansion through its collaborations, which has also allowed it to measure the productivity of the drug discovery platform. Future expansions, of course, are likely to involve outside investors, although Mr Hopkins declines to give details about when strategic decisions will be made.

Being in the sweet spot of immuno-oncology gives Exscientia a good chance of getting investors to listen to its story. A big pharma partner in Sanofi cannot hurt either. Delivering a couple more clinical candidates quickly to validate the speed of its discovery platform will make Exscientia hard for investors to ignore.

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Exscientia Takes Single Molecules To Multiple Pathways In Diabetes - Seeking Alpha

Camp Day2Day is a free camp for youth diagnosed with diabetes or prediabetes sponsored by Baptist Memorial Health Care and the American Diabetes Association. Jim Weber/The Commercial Appeal

Day camper Blayn Dennington withCamp Day2Day checks his blood sugar at the Kroc Center Tuesday afternoon during a break in activities. Camp Day 2Day is a free camp for youth diagnosed with diabetes or prediabetes sponsored by Baptist Memorial Health Care and the American Diabetes Association.(Photo: Jim Weber/The Commercial Appeal)Buy Photo

Like any kidat summer camp, Russell Johnson enjoys theusual offerings of swimming, badminton and touch football, but what will stick with the 12-year-oldmost from the event he's attendingthis week is alesson about how toshopat the supermarket.

"Don't get junk," says the Germantown Middle School student.

Russell was among 32 kids registered forCamp Day2Day, an event for youngsters diagnosed with diabetes or prediabetes, along with those considered at-risk for the disease because of family history and other factors. It'sput on free of charge at The Kroc Center Memphis by Baptist Memorial Health Care and the American Diabetes Association.

The camp's attendance isup45percent from the 22 on hand last year, a reflection, perhaps, of the growing awareness of the perils of diabetes and its grip on the Memphis area.

The city lies within a"diabetes belt" -- a region covering 644 counties in 15 states -- identified by the federal Centers for Disease Control and Prevention. It's an area where at least11 percent of the adult population has been diagnosed with diabetes, an incurable disease characterized by an excess of glucose in the blood, which can lead to nerve damage, blindness, kidney disease, heart trouble and death.

In Shelby County, more than 82,000 residents had been diagnosed with diabetes in 2013, the most recent year for which figures are available, and some 250 people die from it annually.

Camp Day2Day, which attracted kids aged6 through 16,this year includesabout eight youngsterswithType 1 diabetes, traditionally called juvenile diabetes, in which the pancreas produces little or no insulin. Onecamper, Russell, hasType 2 diabetes, the most common form, which occurs when the body develops insulin resistance and can't use the hormone properly.

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Another 5 have been diagnosed with prediabetes, meaning their blood-sugar levels are elevated, but not enough so to be considered diabetic. Most of the remainder were considered at-risk for the disease.

Because Type 2 often stems from obesity or poor eating habits, the camp teaches kids about the importance of a healthful diet and exercise. They learn about portion sizes, counting carbohydrates and, during a field trip to a grocery story, how to choose the right foods.

Russellcan trace his disease largely to family history. His mother had diabetes and died from complications and other factors at age 44, and several other family members have been afflicted.

Russell said he'll benefit most from lessons about how to read nutrition labels and keep his weight in check. Heplans a career in nursing.

"I want to help other people who have diabetes," he said.

Another camper, 12-year-old Andrew Lopez, said the activities such as swimming and footballwill helpprevent his prediabetes from progressing to diabetes.

"Mostof my day I like to spend sitting down reading, watching TV," he said. "Being in this environment helps me be more active."

The camp is modeled on the National Diabetes Prevention Program, which focuses on diet, exercise and behavioral changes. The program, developed by the CDC and implemented by local hospitals and health-care providers, seems to have had an impact locally. Between 2008 and 2013, the number of new cases diagnosed in the county fell nearly 19 percent, from 7,918 to 6,439, according to CDC figures.

Day campers Seraiah Johnson and Mallory Johnson (right) withCamp Day2Day play something akin to basketball at the Kroc Center Tuesday afternoon. Camp Day 2Day is a free camp for youth diagnosed with diabetes or prediabetes sponsored by Baptist Memorial Health Care and the American Diabetes Association.(Photo: Jim Weber/The Commercial Appeal)

Jennifer Reed, diabetes education program manager for the Baptist Medical Group Outpatient Care Center, and Melissa Wilson, community health strategist with the ADA, said they're confident the camp can help the kids either avoid developing full-blown diabetes, or, if they already have the disease,at least manage it so they don't develop the debilitating complications.

"It's a process," Reed said. "We hope they'll walk away with a better understanding."

Reach Tom Charlier atthomas.charlier@commercialappeal.comor 901-529-2572 andon Twitter at @thomasrcharlier.

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Baptist camp helps kids fight diabetes - The Commercial Appeal

When I was pregnant with my fifth baby, I went into the doctors office and found out that I was at risk for gestational diabetes.

I had been preparing for the big event everything from new clothes to a brand new baby carrier but didnt really think about what I had been eating.

As part of everyones prenatal care, about 24 to 28 weeks into your pregnancy, your physician will perform a simple blood test to evaluate how your body reacts to insulin. For almost 10 percent of expectant moms, those results indicate gestational diabetes.

Gestational diabetes poses health risks for the baby, such as high birth weight, jaundice and breathing problems. It can also put you at risk for serious health problems, like high blood pressure and preeclampsia a potentially fatal condition that damages your kidneys and other organs. But, even if you have gestational diabetes, you can minimize your risk with a good diet and exercise plan.

If you have been diagnosed, here are four proven ways to control the negative effects of gestational diabetes:

Leading an active lifestyle is important for everyone, particularly pregnant women. The good news is that it doesnt require a lot of time to benefit from exercise. A simple 10-minute walk around the block or a relaxing yoga session can also help maintain a healthy weight and relieve stress while keeping GD in check.

Doesnt it seem like comfort foods always taste better when you are pregnant? A glass of milk and a doughnut or two or five really satisfy. But many of those foods we crave are loaded with carbohydrates, and that can spike our blood sugar levels. Instead, focus on fresh fruits and vegetables, and whole grains. For example, tart cherries are a delicious addition to your diet.

Tart cherries have been proven to reduce pain and inflammation, Pam Nisevich Bede, RD., a sports nutrition expert, said, adding that cherries reduce arthritic and joint pain and improve heart health.

To avoid spikes in blood sugar levels, try spreading smaller meals throughout the day. Doctors recommend eating three meals and two to three snacks per day. Eating smaller meals more frequently can help you keep your blood sugar levels stable.

By shifting your diet to include low-glycemic foods, you can better control symptoms of gestational diabetes.

Whether you are pregnant or want to be in the near future, its never too late to change your diet, said Ricardo Rueda, MD, PhD. Make an effort to include foods that dont cause sharp rises in your blood sugar and those that have slowly digestible carbs. Doing so lowers your risk of gestational diabetes and, for your baby, it lowers the risk of future obesity.

Fortunately, its easy to incorporate low-glycemic foods into your diet. There are a variety of fresh fruits and vegetables, whole grain cereals and bread, lean cuts of meat, and nonfat dairy products from which to choose.

Pregnancy really is an opportunity to give you and your baby the best start toward healthy futures. By maintaining healthy blood sugar levels with regular exercise, a sensible, balanced diet consisting of frequent meals throughout the day, and talking regularly with your doctor about occurring symptoms, women can still have a happy and healthy pregnancy even with gestational diabetes.

Amy Osmond Cook, Ph.D., is the executive director of the Association of Skilled Nursing Providers, Publisher of 39forlife.com, and CEO of Osmond Marketing. Follow her at @doctorosmond.

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Health & Wellness: 4 most effective ways to control gestational ... - Daily Herald

Courtney Warren arrived at the Amarillo offices of the Juvenile Diabetes Research Foundation two years ago with her sister and 3-year-old nephew, Bray Jones, who had been diagnosed with Type 1 diabetes after a test revealed his blood sugar was six times the normal amount.

Warren remembers how her family struggled to understand Brays diagnosis, and she said learning to live with a Type 1 child was exhausting for the family.

Warren said the family leaned on JDRF at the time. So, when the foundation closed its West Texas Plains branch in October to redirect funds for more research, Warren joined with a group of concerned parents of children with Type 1 diabetes and past JDRF executive board members to develop a group to help fill the gap.

Now Warren is vice president of Type One Area Diabetics Support, or TOADS, which launched in Amarillo last week under the 501(c)(3) umbrella of the Family Care Foundation. One of the new organizations primary goals is to make sure families are supported.

You dont sleep at night, Warren said of having a young family member with Type 1 diabetes.

You have to test your kid every two hours to test their blood sugar, and theres a thing called dead in bed where they have really low blood sugar and then they just basically fall into a coma and pass away.

Its horrible and really scary, she said

TOADS five-goal plan is to provide support, education, Continuous Glucose Monitoring device drives, tactical kits for hospital visits and scholarships for diabetes camps and eventually college.

Warren said she met with a family last week whose son was recently diagnosed with Type 1 diabetes.

Just the fact that they were there, they were scared and we met them that alone is worth it, Warren said. They have someone they can lean on and have a group they can go to.

Warren said she also wants to go into schools and educate children about why they shouldnt see shame in a Type 1 diagnosis.

TOADS is planning its first large fundraiser this fall, Warren said, and theyre hoping to raise $100,000 for local support.

We just want to help the Type 1s and their families because its a scary diagnosis, Warren said.

We dont have a cure yet, and JDRF is the leading research (group) in the world. ... I do believe they will find a cure within my nephews lifetime, but we just want to help people in the meantime.

Until theres a cure, we are here to help you understand it, help you get the device you need and information and education you need.

What is TOADS?

Type One Area Diabetics Support, or TOADS, is a new organization formed to fill the gap left when the West Texas Plains branch of the Juvenile Diabetes Research Foundation closed its doors in October. TOADS offers support, education, device drives, tactical kits and scholarships to type 1 individuals and their families. For more information, visit their Facebook page facebook.com/fcftoads or call 806-567-8005.

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Amarillo group fills gap left by juvenile diabetes foundation's closure ... - Amarillo.com

By Emily Kopp June 7, 2017

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Patients notched a rare win over the pharmaceutical industry Monday when the Nevada Legislature revived a bill requiring insulin makers to disclose the profits they make on the life-sustaining drug. In a handful of other states, bills addressing drug prices have stalled.

Many of the 1.25 million Americans who live with Type 1 diabetes cheered the legislative effort in Nevada as an important first step in their fight against skyrocketing costs of a drug on which their lives depend. The cost of insulin medications has steadily risen over the past decade by nearly 300 percent.

Prominent patient advocacy groups, like the American Diabetes Association, have maintained stony silence while diabetes patients championed the bill and lobbied the legislature during this debate a silence that patients and experts say stems from financial ties.

Normally all of the patient advocacy groups rally around causes and piggyback on each other in a productive way thats what advocacy groups are good at but that hasnt been the case here, said Thom Scher, chief operating officer of Beyond Type 1, which does not accept donations from the pharmaceutical industry. Beyond Type 1 has not issued a formal opinion on the Nevada bill.

Many of the dozens of U.S. diabetes advocacy organizations, large and small, garner significant portions of their funding from insulin manufacturers. The Nevada bill also requires such organizations operating in-state to disclose all contributions they receive from the pharmaceutical industry to discourage that sort of conflict.

In 2016, two of the big three insulin producers Eli Lilly and Sanofi contributed at least $4.7 million to such national patient advocacy groups as the American Diabetes Association, Diabetes Patient Advocacy Coalition (DPAC), JDRF International and the Diabetes Hands Foundation, according to company disclosures. The third major insulin manufacturer, Novo Nordisk, does not disclose its charitable contributions.

The advocacy groups have taken no position on the Nevada legislation. Generally speaking, their advocacy focuses on pressuring insurers to pay the price of insulin, not protesting price rises.

Local diabetes groups, hardly free from conflicts with the pharmaceutical industry, have also stayed on the sidelines.

The Nevada Diabetes Association for Children and Adults officially issued a neutral opinion.

The Nevada Diabetes Association supports regulations on medications. The problem with SB 265 is that it is not just regulating medication but the industry, said Executive Director Sarah Gleich.

The nonprofit does not list its fiscal sponsors on its website or most recent 990 tax form.

We disclose what we have received, and the IRS does not require that we publicly publish from whom, Gleich said. No one is giving out their invitation list to the party.

Gleich said the Nevada Diabetes Association receives table sponsorships and supplies for camp programs from the pharmaceutical industry but nothing that would make a dent on the budget. Auditing non-monetary donations in order to meet the bills transparency requirement would be burdensome, Gleich said.

Membership dues accounted for only about $6,000 of the groups $320,000 in revenue last year, according to its latest tax form.

The American Diabetes Association which operates a Nevada chapter accepted at least $3.9 million from Eli Lilly and Sanofi last year.

The American Diabetes Association believes that no individual in need of lifesaving medications such as insulin should ever go without due to prohibitive costs, Michelle Kirkwood, its director of strategic communications and media relations, said in a statement. She would not say whether the nonprofit supports the bill.

Former American Diabetes Association president Larry Hausner wrote an op-ed in the Nevada Appeal opposing the legislation. Caring for people with diabetes involves more than what they pay for insulin or another medication, Hausner wrote. As a lifelong patient advocate, I know Nevadans expect more out of their elected officials. Hausner, now the president of a consulting and public affairs firm, serves on the board of directors of Research!America, a nonprofit promoting increased federal funding for public health research, alongside Sanofis president of global research & development, Elias Zerhouni.

The Diabetes Hands Foundation expressed neutrality on the bill. This state priority in Nevada is a good step towards a larger conversation about the costs of chronic care conditions like diabetes, said the foundations director of advocacy, Mandy Jones. But its hard to know the particular outcome of this particular bill in the U.S. market.

JDRF International would not comment. DPAC deferred questions to the National Diabetes Volunteer Leadership Council.

Against the backdrop of silence from these patient advocacy groups, a community of diabetes patients on Twitter elevated the bills profile around the hashtag #insulin4all, created by T1International, a group in the United Kingdom that does not accept pharmaceutical donations.

People feel frustrated. At the federal level, were not being seen because theres so much going on politically, said Erin Gilmer, aColorado advocate with Type 1 diabetes. It might have to be a state-by-state movement.

Sen. Yvanna Cancela, who sponsored the bill, said she believed requiring diabetes advocacy groups to reveal their sources of funding was key to understanding their positions and bringing prices down. I believe there should be transparency across the health care system, Cancela said.

Gov. Brian Sandoval said Monday night that he intends to sign the bill, according to a Nevada Independent reporter. If the governor takes no action, the transparency rules become law. The bill, SB539, incorporates provisions of an earlier bill approved by the legislature but vetoed by Sandoval. Sponsors stripped a controversial provision that would have required insulin manufacturers to warn patients 90 days before raising prices, which stoked concerns about drug stockpiling, the Associated Press reported Monday.

The Nevada bill is definitely a step in the right direction, said Elizabeth Rowley, founder and director of T1International. Almost anything requiring more transparency is incredibly important right now, especially at a time when almost all diabetes patient advocacy groups take funding from drug and device companies.

Laura Marston, an advocate in Washington, D.C., with Type 1 diabetes, said that there is plenty of grass-roots support for legislation on insulin prices but that advocacy organizations are not listening to the right people.

There should be more focus on the one thing we need to survive. Without insulin, I die a horrendous death in 12 to 24 hours, Marston said. No grass-roots support? Theres desperation.

KHNs coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

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Daylight On Diabetes Drugs: Nevada Bill Would Track Insulin ... - Kaiser Health News

WASHINGTON, D.C. - U.S. Senators Shelley Moore Capito (R-W.Va.) and Gary Peters (D-Mich.) on Wednesday reintroduced the Preventing Diabetes in Medicare Act, which aims to improve the health of people at risk for diabetes, and save long-term costs for Medicare.

Under current law, Medicare will only cover medical nutrition therapy services for individuals already diagnosed with diabetes or renal disease. This bipartisan legislation would extend Medicare coverage for medical nutrition therapy services for Americans with pre-diabetes and risk factors for developing type-2 diabetes.

With one of the highest rates of adult diabetes in the nation and a considerable pre-diabetes population, West Virginia is no stranger to the costs and challenges associated with this disease, Senator Capito said. The Preventing Diabetes in Medicare Act will help stem the growing rate of diabetes and reduce the one-in-three Medicare dollars being spent on it.

Investing in preventative care for diabetes will save taxpayer dollars by reducing Medicare costs and help at-risk individuals live longer and healthier lives, said Senator Peters. I am proud to reintroduce this commonsense, bipartisan legislation to expand medical nutrition therapy services and help prevent more seniors from developing this chronic and costly condition.

Nearly one in every three Medicare dollars is spent on diabetes, a number that has increased considerably in recent years and will most likely continue to increase without action. The Centers for Disease Control (CDC) estimates approximately 30 million Americans or 9.3 percent of the population have diabetes and approximately 86 million American adults about 30 percent of the population have pre-diabetes.

There is significant evidence to suggest that medical nutrition therapy can prevent the onset of diabetes for at-risk individuals. According to the Agency for Healthcare Research and Quality, $2.5 billion in hospitalization cost related to the treatment of diabetes or complications resulting from diabetes could be saved by providing seniors with appropriate preventive care. Medical nutrition therapy includes an initial nutrition and lifestyle assessment, review of eating habits, one-on-one nutritional counseling and follow-up visits to check on patients progress in managing their diet to prevent or manage their condition.

The Preventing Diabetes in Medicare Act has broad support from major health care groups, including Academy of Nutrition and Dietetics, Spectrum Health, Diabetes Advocacy Alliance, Food is Medicine Coalition, Healthcare Leadership Council, National Association of Nutrition and Aging Services Programs and Michigan Academy of Nutrition and Dietetics.

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WV Senator Capito reintroduces Preventing Diabetes in Medicare Act - The News Center

Researchers say people with diabetes who took SGLT2 inhibitors were twice as likely to develop the rare condition as those who didnt take the drug.

SGLT2 inhibitors, which are some of the newest diabetes drugs on the market, may increase the risk of a serious condition.

A new study concludes that these medications actually double the likelihood of developing diabetic ketoacidosis.

Because diabetes is becoming more prevalent in the United States, the hunt for new and more effective medication is in full flow.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are the most recent additions to the list of available medicines.

SGLT2 inhibitors reduce blood glucose levels by encouraging the kidneys to increase sugar excretion in urine.

These drugs are often given in combination with other diabetes medications, such as metformin and insulin.

The new class of drugs has become relatively popular, but the latest research finds that they could increase the risk of a serious diabetes-related complication.

Read more: First Indy 500 driver with diabetes talks about life, racing

Diabetic ketoacidosis is relatively uncommon but potentially life-threatening.

It occurs when acids called ketones build up in the body, increasing the acidity of the blood, or when the body does not produce enough insulin.

When insulin is absent, glucose cannot enter cells and provide them with the energy they need.

Therefore, the body falls back on its secondary fuel source: fat. Ketones are byproducts of burning fat.

Symptoms of diabetic ketoacidosis include increased thirst, abdominal pain, nausea and vomiting, and confusion. It can also cause swelling in the brain, and, if left unchecked, can be fatal.

Although diabetic ketoacidosis is more likely to occur in people with type 1 diabetes, it does occasionally appear in individuals with type 2 diabetes.

Read more: Resveratrol may be beneficial to people with diabetes

The new study, carried out by Dr. Michael Fralick and a team from Brigham and Womens Hospital in Boston, set out to examine the interaction, if any, between SGLT2 inhibitors and diabetic ketoacidosis.

The teams findings were published today in the New England Journal of Medicine.

Fralick decided to investigate this relationship after one of his patients with type 2 diabetes showed up at the emergency room with symptoms of diabetic ketoacidosis.

As Fralick explains, My best research projects come from my patients. Their experiences drive the questions I investigate.

In April 2013, SGLT2 inhibitors came onto the market.

Clinical trial data showed that they were relatively safe for use by patients with type 2 diabetes.

However, in 2015, the Food and Drug Administration (FDA) issued a warning on this drug type following reports of increased rates of diabetic ketoacidosis.

Read more: List of diabetes medications

The latest study used data from 40,000 patients and compared the outcomes of individuals taking SGLT2 inhibitors with patients taking a DPP4 inhibitor, which are diabetes drugs that help to maintain higher insulin levels by blocking a specific enzyme.

After 180 days, 26 patients taking the DPP4 inhibitor were diagnosed with diabetic ketoacidosis, compared with 55 individuals taking SGLT2 inhibitors, equating to more than double the risk.

However, it is important to note that diabetic ketoacidosis is still a rare consequence of diabetes, with or without SGLT2 inhibitor use.

The importance of these findings lies more in how doctors might approach treating patients with these types of symptoms.

Although the overall numbers of diabetic ketoacidosis cases are low, Fralick believes that the effect may be even larger than the studys data show.

This is a side effect that's usually seen in patients with type 1 diabetes mellitus - not type 2 - so doctors are not 'on the lookout' for it, Fralick explains. That means that the risk of this side effect might actually be even higher than what we found due to misdiagnosis/under recording.

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New Diabetes Drugs May Bring On Ketoacidosis - Healthline

The daily or once-weekly insulin shotnecessary for the control of type 2 diabetescould be replaced by a twice- or even once-a-month shot. A new, longer-lasting injectable formulation has been developed that combines a familiar diabetes-control molecule, glucagon-like peptide-1 (GLP1), with a heat-sensitive elastin-like polypeptide (ELP). Once a solution containing the GLP1ELP combo passes through a standard needle and penetrates the skin, it reacts to body heat, forming a biodegradable gel-like depot that slowly releases the drug as it dissolves.

The novel drug-delivery mechanism was developed by scientists based at Duke University, who assert that it could be used to enhance therapeutic outcomes by eliminating peak-and-valley pharmacokinetics and improving overall safety and tolerability. The scientists, led by Ashutosh Chilkoti, Ph.D., chair of the department of biomedical engineering at Duke, suggest that their work could be broadly applicable; that is, it could improve the pharmacological performance of peptides and protein therapeutics besides GLP1.

Details of the work appeared June 5 in the journal Nature Biomedical Engineering, in an article entitled One-Week Glucose Control via Zero-Order Release Kinetics from an Injectable Depot of Glucagon-Like Peptide-1 Fused to a Thermosensitive Biopolymer. The one week indicated in the title refers to the drug depots performance in mice. Glucose control, the scientists found, was more durable in rhesus monkeys, and even longer glucose control, the scientists suggested, could be achieved in humans, since humans have slower metabolisms than mice or monkeys.

A subcutaneous depot formed after a single injection of GLP1 recombinantly fused to a thermosensitive elastin-like polypeptide results in zero-order release kinetics and circulation times of up to 10 days in mice and 17 days in monkeys, the authors of the article indicated. The optimized pharmacokinetics lead to 10 days of glycaemic control in three different mouse models of diabetes, as well as the reduction of glycosylated haemoglobin levels and weight gain in ob/ob mice treated once weekly for 8 weeks.

Many current treatments for type 2 diabetes use GLP1, a signaling molecule that causes the pancreas to release insulin to control blood sugar. However, this peptide has a short half-life and is cleared from the body quickly.

To make treatments last longer, researchers have previously fused GLP1 with synthetic microspheres and biomolecules like antibodies, making them active for 2 to 3 days in mice and up to a week in humans. Currently, the longest-acting glucose control treatment on the market, dulaglutide, requires a once-weekly injection, while standard insulin therapies often have to be injected twice or more every day. Despite improvements such as these, many treatments don't include a mechanism to control the rate of the peptide's release, and treatment effectiveness can plateau after prolonged use.

The Duke researchers persisted with their ongoing experiments, which focused on thermosensitive delivery biopolymers. By varying the design of their delivery biopolymers at the molecular level, they found a sweet spot that maximized the duration of the drug's delivery from a single injection, noted Dr. Chilkoti. "By doing so, he continued, we managed to triple the duration of this short-acting drug for type 2 diabetes, outperforming other competing designs."

Building upon their previous work with the drug and delivery system, researchers in the Dr. Chilkotis laboratory optimized their solution to regulate glucose levels in mice for 10 days after a single injection, up from the previous standard of 2 to 3 days.

In further tests, the Duke team found that the optimized formulation improved glucose control in rhesus monkeys for more than 14 days after a single injection, while also releasing the drug at a constant rate for the duration of the trial.

"What's exciting about this work was our ability to demonstrate that the drug could last over 2 weeks in nonhuman primates," remarked Kelli Luginbuhl, a Ph.D. student in Dr. Chilkotis laboratory and co-author of the study. "Because our metabolism is slower than monkeys and mice, the treatment should theoretically last even longer in humans, so our hope is that this will be the first biweekly or once-a-month formulation for people with type 2 diabetes."

Despite a variety of treatment options, managing type 2 diabetes still poses a problem. Patients don't always reach their glycemic targets, and adherence to a treatment plan that relies on frequent, meal-specific dosing leaves room for human error. By limiting the number of injections a person will need to control their glucose levels, the researchers hope this new tool will improve treatment options for the disease.

The researchers now plan to study the immune response to repeated injections and test the material with other animal models. They are also considering additional applications for this controlled-release system, such as delivering pain medication.

Dr. Chilkoti also indicated that because the drug is synthesized inside Escherichia coli bacterial cultures instead of mammalian cells, it is cheaper and faster to produce, making it a potential target for use in developing countries once it's commercialized.

According to a report issued last year by Grand View Research, the global insulin market is expected to reach $53.04 billion by 2022. Grand View anticipates that the most lucrative segment will consist of long-acting analogs. The segments high growth rate, estimated at 15.0%/year, is accounted for by fast-selling products such as Lantus by Sanofi Aventis. Moreover, the addition of new products such as Novo Nordisks Tresiba ultra-long-acting analog is expected to further drive segment growth. Tresiba is administered subcutaneously once daily at any time of day. Even longer-lasting formulations, such as those contemplated by Dr. Chilkotis team, may contribute to yet more growth in the segment.

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Month-Long Diabetes Control Possible with New Injection | GEN - Genetic Engineering & Biotechnology News