Category Archives: Diabetes

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A new study from the Scripps Whittier Diabetes Institute in La Jollashows that texting could be as good as medication at improving Type 2 Diabetes management.

The study looked at a low-income Hispanic community, known to have a high-rate of diabetes.

Lower income individuals sometimes dont havethe education to know what is the right approach to taking care of diabetes," said Dr. Athena Philis-Tsimikas, who spearheaded the study.

The 63 participants who were randomly assigned to the study group received 354 texts over six months--about two to three short messages a day.

Some of the reminder texts read: "Use small plates! Portions will look larger and you may feel more satisfied after eating."

Another text said, "Time to check your blood sugar. Please text back your results."

Ninety-sixpercent of the study group participants said the text messages helped them to manage their diabetes "a lot" by the time the trial ended.

"I lost weight," said Gloria Favela, a mural artist from Valley Center. "My blood sugars dropped. They were at a really healthy level.

Published at 9:49 PM PDT on Jun 9, 2017 | Updated at 10:08 PM PDT on Jun 9, 2017

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Study Shows Texting Could Help Type 2 Diabetes Management - NBC 7 San Diego

Lexicon Pharmaceuticals has posted upbeat data from another phase 3 trial of its Sanofi-partnered dual SGLT1 and SGLT2 inhibitor sotagliflozin. More patients in the treatment arm hit an established target for glycemic control than did in the control cohort, resulting in Lexicon chalking up its third phase 3 success for the diabetes tablet.

The latest trial enrolled 1,402 patients with type 1 diabetes and randomized them to receive either sotagliflozin or placebo. Going into the study the subjects had A1C levels ranging from 7% to 11%. Diabetes associations recommend that patients reduce their A1Clevels to below 7%. A1C is a marker that gives an average blood glucose level. The phase 3 trial assessed the proportion of participants in the sotagliflozin and placebo arms whose A1C levels fell to below 7% over 24 weeks of treatment.

Lexicon said the trial linked sotagliflozin to a statistically-significant improvement in the proportion of patients who met the A1C target. The finding adds to evidence that sotagliflozin helps patients with Type 1 diabetes to control their glucose levels.

Exactly how positive the data are is unclear. In the top-line release Lexicon said the trial met its primary endpoint but provided no details about what proportion of patients in each arm saw their A1C levels fall to below 7%. That datapoint will go some way to showing whether sotagliflozin can go beyond beating the placebo and establish itself as an effective treatment for type 1 diabetics.

The FDA and other regulators have already approved inhibitors of SGLT2, one of the targets hit by sotagliflozin, for use in type 2 diabetics. AstraZeneca and Bristol-Myers Squibbs Farxiga, Boehringer Ingelheim and Eli Lillys Jardiance and Johnson & Johnsons Invokana all compete for this niche.

Lexicon thinks sotagliflozin can improve on these existing therapies by also hitting SGLT1, which mediates the absorption of glucose in the intestines. SGLT2 plays a similar role in the kidneys.

Sanofi identified sotagliflozin as a way to enter and disrupt the nascent market for SGLT2 inhibitors in 2015, prompting it to pay $300 million upfront and up to $1.4 billion in milestones for the global license to the experimental drug. And with sotagliflozin having now come through three phase 3 trialsthe first two of which assessed the change in A1C from baselineit is nearing the day on which it can start recouping some of its outlay.

We look forward to pursuing regulatory submissions for the treatment of type 1 worldwide, Sanofi SVP Jorge Insuasty said in a statement.

Sanofi plans to pursue approvals of sotagliflozin in type 1 diabetes while developing the drug for use by people with the type 2 form of the condition. The French Big Pharma is running three phase 3 trials to assess the effect of sotagliflozin on the A1C levels of patients with type 2 diabetes. Sanofi expects to complete the trials in 2018 and 2019.

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Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi - FierceBiotech

The 77th Annual American Diabetes Association conference is set to begin today in San Diego. Running through Tuesday, the convention will highlight advances for the metabolic disease and likely bring further attention to ongoing issues that have been plaguing the space particularly, the rising cost of insulin and problems with patient adherence to treatment.

This years conference will include more than 15,000 participants looking to consume the 378 abstracts and 2,152 poster presentations. Much like the ADA conference last year, which was dominated by cardiovascular outcomes data for Eli Lilly & Co.s SGLT-2 inhibitor Jardiance (empagliflozin), some of the most pressing data will be further CV outcomes results.

The show isn't as relevant as it once was due to a dwindling diabetes pipeline, but there are still major pharma companies working diligently in the space. "This show has changed so much over the years because the business has changed so much. Diabetes drugs have really become commodities," said David Kliff long time investor, diabetic and author of industry newsletter the Diabetic Investor in an interview.

Here are several items from the conference that could get your blood sugar up:

Now that Lilly and Boehringer Ingelheim have garnered an updated label from the Food and Drug Administration for Jardiance that includes cardiovascular outcomes data from the EMPA-REG trial, other drugmakers are looking to prove that its a class-wide effect.

"If you look at Jardianceand the EMPA-REG data, which was really revolutionary it didn't really help them sales-wise," said Kliff. "This tells you about the power of the payer, it tells you that a lot of the experts believe it was a class-effect; these drugs are really becoming a commodity in a way."

Johnson & Johnson will be presenting data on Monday from its own cardiovascular outcomes trial for its SGLT-2 inhibitor Invokana (canagliflozin). The first in the class approved by the FDA, Invokana grew the market and has long been the market leader, but having outcomes data in hand has allowed Lilly and Boehringer to gain ground.

The 10,000-patient strong CANVAS clinical trial program will provide further insight into the cardiovascular benefits of one of diabetes youngest classes of drugs. Lilly and Boehringer will also be making six presentations beginning Saturday further discussing EMPA-REG.

J&J isnt the only company presenting cardiovascular outcomes data. Novo Nordisk will be presenting further data from the 7,000-patient DEVOTE study comparing its basal insulin Tresiba (insulin degludec) with long-time market leader Lantus (insulin glargine).

The initial results were announced last November and showed that Tresiba was non-inferior to Lantus although not superior. Although the Novo drug did show superiority on the secondary endpoint of hypoglycemia.

Novo Nordisk is now seeking approval from the FDA to get the info added to the label. Yet, the agency has been fairly strict with diabetes companies and hasnt considered things like hypoglycemia to be major differentiators.

Keep an eye out Monday for more insight on how the struggling Danish drugmaker might seek further differentiation from competitors.

Amgen and competitors Regeneron and Sanofi have been making headlines for two years now for their pricey cholesterol-lowering PCSK9 inhibitors. Those headlines have gotten ugly, as both Repatha (evolocumab) and Praluent (alirocumab) continue to struggle commercially. Those struggles are further compounded by the ongoing legal battle between the companies over patent rights.

Diabetes is an area that PCSK9 inhibitors have only dabbled in. The high-risk patient population has been included minimally in previous clinical trials, but new data to be presented on Sunday will focus on trials specifically geared toward diabetes patients.

Previous clinical data has shown correlations between PCSK9 levels and insulin levels, but the new studies will look at the safety, tolerability and efficacy in the glycemic-related endpoints.

If the PCSK9 inhibitors are successful in this patient population, then this could be the commercial boost that these players need to finally make a dent in the market.

Both Apple and Google have been moving beyond their respective realms of computer hardware and the internet to get into healthcare.

While neither company has yet to enter the realm of clinical trials and drug development, they are about to make a splash on the diabetes landscape. Apple has partnered up with Dexcom to bring constant glucose monitoring to the Apple Watch. This addition could be a major advancement for patient adherence, allowing patients to have easier access to glucose numbers and better monitor their blood sugar.

Meanwhile, Googles sister company Verily teamed up with Sanofi to launch OnDuo, a company meant to combine Verilys software expertise with Sanofis diabetes experience to bring disease management solutions to patients.

Both of these deals are part of a larger trend toward using technology to bring better drug adherence solutions to patients. Technology is bringing to patients tools such as smart pill bottles to help them track doses, and cell phone apps that give them reminders about both taking medications and getting to physician appointments.

One of the many symposia to be presented throughout the long-weekend will deal with the rising cost of insulin. On Saturday, conference goers will be able to hear about how the diabetes staple has risen in price and what it means for the market and patients.

Companies including Novo Nordisk, Lilly and Sanofi have been under fire even facing law suits over how insulin prices have risen in recent years.

Yet, some in the industry argue the pharma companies arent to blame, that they are just complying with market forces while dealing with a complex payment system. "This isn't simple math, it's algebra. There are just tons of variables," said Kliff. "Insulin really doesn't cost too much. People get lost in the cash-paying side of the market, which is small percentage. If you have insurance it costs like nothing. A lot of patients don't understand rebates and net prices and all these other things."

While the industry will continue to point to the third-party payers as the evil doers of pricing, expect that debate to rage on, especially as more biosimilar insulins enter the market and put further pressure on pricing dynamics.

Continue reading here:
ADA preview: 5 things to watch in diabetes - BioPharma Dive

Lexicon Pharmaceuticals $LXRX is now three-for-three in its Phase III program for sotagliflozin, setting up regulatory applications for this Sanofi-partnered therapy as the first pill to help Type 1 diabetics with glycemic control. And it positions the Texas biotech for its late-stage effort aimed at proving it can do the same for Type 2 diabetes.

Investigators tested this add-on drug in 1,402 patients with A1C levels between 7% and 11%, with a 400 mg dose beating a placebo in pushing a significant number of patients below the 7 mark the magic number for glycemic control in diabetes. But well have to wait for a scientific conference to get the details from inTandem3.

The important point for now is that Lexicon appears poised to pursue marketing approval for a novel drug that targets both SGLT-1 and SGLT-2. SGLT-2 drugs like Jardiance, Invokana and Farxiga have already made their mark on the market, blocking glucose absorption in the kidneys. But this therapy adds another target in the intestinal tract.

This may not revolutionize therapy, but in diabetes R&D developing drugs for a mass audience of millions around the globe every incremental step forward marks blockbuster potential.

Sanofi saw the promise and came in to bag the worldwide rights to the drug leaving Lexicon with US co-promotion rights with a $300 million upfront payment and $1.4 billion in potential milestones.

This has been a watershed year for Lexicon. Just a few months ago the biotechcompleted a marathon development program with anFDA approvalof telotristatethyl (which will be sold as Xermelo and was formerly known as LX1032) for carcinoid syndrome, which is linked with severe diarrhea.

Lonnel Coats

These positive results represent an important milestone, further supporting sotagliflozins differentiated profile as a novel, oral anti-diabetic agent with potential to benefit people with type 1 diabetes, said Lonnel Coats, Lexicons president and chief executive officer, in a prepared statement. Sotagliflozin is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase III clinical trials in this population.

News reports for those who discover, develop, and market drugs. Join 16,000+ biopharma pros who read Endpoints News articles by email every day. Free subscription.

Read more from the original source:
Lexicon 3-for-3 in PhIII for a new diabetes pill, racking up a clean sweep under $1.7B Sanofi pact - Endpoints News

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High blood glucose levels can be harmful to the mother and unborn baby, and can raise the babys risk for excessive birth weight, preterm birth, and type 2 diabetes later in life. In contrast, cold temperatures are believed to improve the bodys ability to produce insulin.

Dr. William Holcomb, OB/GYN at SSM Health St. Joseph Hospital says this study is no reason for alarm, they should focus on the more serious risks for developing gestational diabetes which are body weight and family history. There's not much you can do about the ambient temperature, I wouldn't invest a bit of worry in that, what I would focus on is, Do I have a good diet and am I exercising regularly, and am I taking good care of myself.

Its recommended that pregnant women avoid prolonged outdoor activity during hot summer months, remain in an air-conditioned environment, and dress in cool clothing. Other strategies women can follow to protect themselves from gestational diabetes include maintaining a healthy body weight before conception, avoiding excess weight gain during pregnancy, consuming a healthy diet and staying physically active. These strategies are especially important for women who have existing risk factors for gestational diabetes, family history of type 2 diabetes, or have had gestational diabetes in a previous pregnancy. They are encouraged to consult with their physician about their individual risk factors.

To find out more about gestational diabetes, click here.

Link:
SSM Health Medical Minute: Gestational Diabetes is linked to ... - fox2now.com

Wayne State University has received a $3.05 million grant from the National Institute of Health for a five-year trial focused on helping parents and other caretakers assist diabetic adolescents to complete their daily care.

The trial is aimed at African-American young people diagnosed with Type 1 diabetes, because they are considered to be at higher risk for poor diabetes management, according to Wayne State's website.

The five-year trial will study a computer-delivered intervention during doctor visits that reminds and motivates parents to stay involved in their child's care, the university said in a statement. During visits to the clinic, caretakers will be given a tablet on which an avatar will take them through a sort of multimedia course that includes informational video clips, testimonials, motivational content and goal-setting strategies. Test trials have already been conducted and indicate that the intervention is effective.

"Research has shown that maintaining high levels of parental involvement and supervision of daily diabetes care is a critical predictor of youth diabetes management," said Deborah Ellis, Ph.D., professor of family medicine and public health sciences in Wayne State's School of Medicine. "However, physicians do not always have time to discuss parenting behaviors during busy clinic visits."

It will be rolled out in October at the Children's Hospital of Michigan as well as three sites in Chicago, Ellis said. Between 200 and 250 African-American adolescents will be included in this trial.

See the original post here:
WSU gets $3 million NIH grant for improving diabetes care in youth - Crain's Detroit Business

Its become a punchline in the tech industry that every start-up is out to change the world. When it comes to medical technology, however, some of the biggest names in Silicon Valley are poised to do just that.

Apple, Google and Amazon have announced or are reported to be developing cutting-edge technologies for managing diabetes, one of the fastest-growing chronic illnesses, affecting more than 420 million people worldwide.

Experts say were at the dawn of a new era of personal technology for a variety of chronic conditions, including diabetes, heart disease and hypertension.

It really isnt a surprise youd see companies like Apple and Google focusing on this, said Mike Matson, a senior analyst at the investment firm Needham & Co. Theyre always looking for new opportunities for growth and healthcare is a big market.

Managing a chronic condition can depend on easy access to data, he said. If youre a Google or Apple, you know how to manage data.

The latest diabetes-related tech endeavor to be announced is the Alexa Diabetes Challenge, which focuses on finding ways for the Amazon Echo smart speaker and its Alexa digital assistant to assist people with Type 2 diabetes in living healthier lives.

Type 2 is by far the most common form of diabetes, frequently associated with obesity. Roughly 95% of the nearly 30 million Americans with diabetes are Type 2.

The Alexa challenge features a $125,000 grand prize for whoever comes up with the best diabetes app for the Amazon Echo, as well as $25,000 each for up to five finalists. Funding is being provided by the drug company Merck, manufacturer of the Type 2 meds Januvia and Janumet.

Not surprisingly for the tech industry, the contest boasts a very fast pace. It was announced in April. The deadline for submissions was last month. Finalists will be announced in July. Demos of selected apps will be conducted in September and a grand prize winner will be announced in October.

Its thus entirely possible that people with diabetes may be using some of these apps by the end of the year. An Amazon spokeswoman declined to comment.

Theres so much information for diabetes management available, said Sara Holoubek, chief executive of Luminary Labs, a New York consulting firm thats organizing the Alexa Diabetes Challenge on behalf of Merck and Amazon. So why is it still so hard to get that information? Maybe we can change that.

Alexas voice control is the key. Whereas someone newly diagnosed with Type 2 diabetes might not know where to start in researching and managing the disease, being able to ask Alexa basic questions may help get people on the right track.

What can I eat? How much exercise should I get? Holoubek said, citing some of the unknowns that suddenly arise with a diabetes diagnosis. Normally youd ask your endocrinologist or diabetes educator. Alexa could be like having an educator in your home.

But thats just a start. Holoubek said Merck and Amazon envision a networked household that incorporates various smart devices. For example, a person with Type 2 diabetes might weigh himself on a smart scale, which would transmit data to the Echo. The persons blood-glucose monitor would do likewise.

Now imagine if the person asks Alexa if it would be OK to eat some potato chips. Alexa theoretically would be able to calculate the effect this could have on his or her blood sugar. The system would be able to suggest how much activity would be needed to balance things out or, better still, come up with a more healthful snack.

I have Type 1 diabetes the autoimmune form that requires daily insulin injections and managing the disease is a full-time job. I already have some very cool gizmos. I wear a glucose sensor on my torso that sends data to my iPhone, which in turn feeds my blood sugar level to my Pebble smartwatch for easy viewing.

I have an Amazon Echo at home. It would be awesome if I could simply ask Alexa what my blood sugar is if Im puttering around the house without my watch on, or if Im in any danger of my sugar level crashing.

How great would it be if I could ask Alexa how many carbs are in a plate of spaghetti carbonara? Or even have Alexa calculate my insulin dose before a meal?

To be sure, theres much testing to be done and federal approvals to be obtained before such systems are handling anything like that. But the Alexa Diabetes Challenge offers a clear indication that the tech industry is pushing boundaries.

Apple reportedly is busy on this front as well, but, as usual, the company is keeping its cards close to the vest.

According to recent, anonymously sourced reports, Apple is devoting significant resources, and big bucks, to giving its Apple Watch the ability to monitor blood sugar without a sensor being inserted under the skin (such as the one I use).

Others have tried and failed to accomplish this feat, so if Apple can pull it off, this would represent a huge breakthrough in diabetes care.

The company reportedly has dozens of biomedical researchers trying to measure blood sugar using optical sensors, perhaps implanted within the band of the Apple Watch. The sensors would shine a light through the skin that would provide readings in a painless, noninvasive fashion.

CNBC reported last month that Apple Chief Executive Tim Cook was spotted wearing a prototype glucose-tracker with his Apple Watch. As best as I can tell, Cook doesnt have diabetes, so hes apparently been using himself as a guinea pig to see how well his companys technology responds to different foods he eats.

No one at Apple got back to me.

For its part, Googles parent company, Alphabet, announced last year that its life-sciences subsidiary, Verily, was partnering with the French drug company Sanofi on a $500-million joint venture aimed at improving diabetes care. Verily has a separate partnership with the British drugmaker GlaxoSmithKline.

Among the various technologies Verily is pursuing is a smart contact lens that would monitor blood sugar levels. Its being developed in conjunction with the Swiss drug company Novartis.

Like Apple and Amazon, Google clammed up when I got in touch.

Follow this link:
'Alexa, what's my blood sugar level and how much insulin should I take?' - Los Angeles Times

A new class of type 2 diabetes drugs called SGLT2 inhibitors could increase the risk of a rare, life-threatening complication of the disease called ketoacidosis, a new study warns.

SGLT2 inhibitors include prescription medications such as canagliflozin, dapagliflozin and empagliflozin. Brand names are Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.

These drugs first became available in 2013, but in 2015 the U.S. Food and Drug Administration issued a warning about an increased risk for diabetic ketoacidosis when SGLT2 inhibitors are used.

The condition typically occurs in people with type 1 diabetes. And while it is uncommon in people with type 2 diabetes, case reports have shown it can occur with type 2 disease, according to the study authors.

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Some diabetes patients are begging doctors for free samples of life-saving insulin because of costs. Between 2002 and 2013, the price of insulin ...

Ketoacidosis can cause vomiting, abdominal pain, shortness of breath and swelling in the brain. Left untreated, the condition can be fatal, the researchers said.

The new study "essentially confirms what doctors had already suspected," said diabetes expert Dr. Stanislaw Klek, an endocrinologist at NYU Winthrop Hospital in Mineola, N.Y.

"Fortunately, the rate of diabetic ketoacidosis is still very low and should not prevent the usage of this medication class," he added. "It is important to be aware of this potential complication and monitor for symptoms of diabetic ketoacidosis, particularly during periods of illness."

In the new study, researchers at Brigham and Women's Hospital in Boston analyzed data from 40,000 people with type 2 diabetes. They found that those taking SGLT2 inhibitors were twice as likely to develop diabetic ketoacidosis than those taking another class of diabetes drugs called DPP4 inhibitors (drugs such as Januvia and Onglyza).

Still, the risk to any one patient remains very slim, the researchers stressed. They estimated that among patients taking an SGLT2 inhibitor, only about 1 in every 1,000 patients would develop ketoacidosis.

Play Video

A new World Health Organization report says that cases of diabetes have skyrocketed, quadrupling from 108 million worldwide in 1980 to over 420 m...

The findings were published June 8 in theNew England Journal of Medicine.

Even though diabetic ketoacidosis is uncommon, doctors need to closely monitor type 2 diabetes patients for signs and symptoms of the complication, said study author Dr. Michael Fralick. He's from Brigham and Women's division of pharmacoepidemiology and pharmacoeconomics.

"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 said in a hospital news release. "That means that the risk of this side effect might actually be even higher than what we found due to misdiagnosis/under-recording."

Dr. Minisha Sood is an endocrinologist at Lenox Hill Hospital in New York City. Reviewing the findings, she explained that SGLT2 inhibitors "have been a welcome addition to the arsenal of glucose [blood sugar]-lowering medications. They lower blood glucose by increasing the amount of glucose eliminated through the urine."

But the drugs may interfere with levels of a particular hormone, glucagon, which in turn leads to an unhealthy rise in acids called ketones. "When ketone acids build up in the system, this can lead to diabetic ketoacidosis," Sood explained.

She agreed that patients and doctors should be alert to the rare but potential risk for diabetic ketoacidosis, especially in the early weeks after a person starts taking an SLGT2 inhibitor.

But Sood believes the study findings are not reason for patients to immediately switch to another form of diabetes medication.

"SLGT2 inhibitors work extremely well to control diabetes [and they have the added benefit of lowering blood pressure and weight as well] so the benefits definitely outweigh the risks of therapy," she said.

Read this article:
Diabetes drugs linked to higher risk for rare but deadly complication ... - CBS News

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.

Here is the original post:
Honig family planning diabetes fundraiser - Napa Valley Register

One in three adults has pre-diabetes, and one in 10 of those adults dont know they are at risk.

It makes sense that health care providers and their patients with pre-diabetes and diabetes are continuously looking for further education instruction.

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Bell County Diabetes Coalition working on plan - Temple Daily Telegram