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Category Archives: Diabetes
J&J diabetes drug shows heart benefit in large safety study – Reuters
Posted: June 13, 2017 at 10:41 am
Johnson & Johnson's type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting on Monday.
The medicine also led to a reduced risk of hospitalization for heart failure and protection against kidney function decline. But the risk of amputations, particularly of toes or feet, was double versus placebo in the studies of 10,142 patients with type 2 diabetes.
On the study's main goal Invokana, known chemically as canagliflozin, reduced the combined risk of heart-related death, nonfatal heart attack and nonfatal stroke by a statistically significant 14 percent compared with placebo.
"What we actually got here was not just evidence of safety but evidence of benefit," said lead investigator Bruce Neal, professor of medicine at the University of New South Wales Sydney.
"It's a really positive result. This (heart disease) is the main thing that people with diabetes die from," said Neal, who presented the data at the American Diabetes Association meeting in San Diego.
The study was required to prove Invokana did not cause heart complications. The expectation bar was raised, however, after rival drug Jardiance from Eli Lilly and Co and Boehringer Ingelheim in 2015 demonstrated heart protective qualities in a similar large trial. Reduction of heart-related death is now included in the Jardiance label.
"We look forward to working with the FDA and regulators around the world with respect to getting this in the label," James List, head of cardiovascular and metabolism for J&J's Janssen unit, said of the new data.
Two-thirds of patients had confirmed heart disease and the rest were deemed at high risk. They were followed for an average of about four years.
The number of amputations was small but about double that of the placebo group. A warning of increased amputation risk was added to Invokana's prescribing label after it was discovered by safety monitors during an interim analysis of the study.
"Care is warranted in the use of canagliflozin in patients at risk for amputation," a New England Journal of Medicine article on the study said.
Invokana is the market leader among a newer class of type 2 diabetes treatments called SGLT-2 inhibitors, along with Jardiance and AstraZeneca Plc's Farxiga. They work by removing blood sugar through the urine.
Results from a large Farxiga heart safety trial are expected in 2019.
"I think we're going to see much greater use of canagliflozin and the class in type 2 diabetes," Neal said.
Invokana and related combination treatment Invokamet had sales $284 million in the first quarter, J&J reported.
(Reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)
WASHINGTON The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.
Merck & Co said it paused enrolments in two late-stage studies testing its immunotherapy drug, Keytruda, for multiple myeloma, in combination with other therapies, as the U.S. drugmaker looks to better understand more reports of death in the Keytruda groups.
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Cancer Drug Gleevec Might Slow Type-1 Diabetes – NBCNews.com
Posted: June 13, 2017 at 10:41 am
A mans finger is pricked to test cholesterol and blood sugar on August 13, 2009 in Newark, New Jersey. Rick Gershon / Getty Images
Tests done in 67 adults with type-1 diabetes showed the drug appeared to boost their body's own production of insulin, Dr. Stephen Gitelman of the University of California San Francisco School of Medicine told a meeting of the American Diabetes Association.
On average the people that got the medicine used less insulin, Gitelman told NBC News.
He stressed that it is a small trial meant to show the drug can safely do in people what it did in mice.
We just wanted to get a sense if this showed some benefit in adults so we could get to the target population in kids, Gitelman said.
The conservative estimate is that beta cell function was maybe 19 percent better at one year. So its not a slam-dunk home run.
The team will have to get Food and Drug Administration permission to test the drug in children.
About 5 percent of the
Its an autoimmune disease, caused when the body mistakenly destroys pancreatic cells that produce hormones like insulin and glucagon that control blood sugar. High glucose levels damage tiny blood vessels, which in turn can lead to blindness, heart disease, stroke and kidney failure. People can lose toes, feet or legs to amputation.
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When levels fall too low, patients can pass out and sometimes die.
There's no cure and the only treatment is to keep blood sugar under tight control with diet and insulin.
Most people with type-1 diabetes must constantly check their blood sugar throughout the day, administering insulin according to what they are eating and how much they are exercising.
If those dying pancreatic cells could be saved, they might have to do this less often.
That would be one potential pathway -- to use the drug to try to get in as early as possible when there are still as many beta cells remaining as possible and to slow down progression and potentially even keep people off insulin, said Andy Rakeman, director of discovery research at JDRF, the diabetes research charity that funded the study.
Its estimated that people at the time they are diagnosed with type 1 diabetes that they have anywhere between 10 and 15 or maybe even 40 percent of their beta cells still remaining, Rakeman added.
Some people maintain beta cell function for years. We used to think all or nearly all of the beta cells are destroyed very rapidly.
The organization is paying for research looking at several ways to preserve these cells. Gleevec would be a good candidate because its been around for nearly 20 years and while it causes side-effects such as a vomiting and rash, they are usually not severe in the diabetes patients.
Its taking an old drug and repurposing it for a new use, Rakeman said.
Gleevec, known generically as imatinib, and Sutent, known generically as sunitinib, interfere with an enzyme called tyrosine kinase. In patients with cancers such as chronic myelogenous leukemia, cutting back on this enzyme stops the cancer.
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Cancer patients who also had autoimmune diseases who took Gleevec and Sutent reported that the drugs also appeared to ease the symptoms of the other conditions. Thats when a team at UCSF started testing Gleevec in mice bred to develop diabetes.
Gitelman says his team believes Gleevec may be taking some of the pressure off the pancreatic beta cells.
He is a little worried his study may be misunderstood. The team just finished the research last week and theyve rushed to put together a quick presentation to the Diabetes Association meeting. It will be weeks before they can analyze the data and put it into a form that can be reviewed by other experts in a medical journal.
Its early and the message could be misconstrued, Gitelman said.
This definitely does not show that Gleevec is curing type 1 diabetes, Rakeman stressed.
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Plus, Gleevec is expensive.
It costs more than $140,000 a year, according to Dr. Hagop Kantarjian of the University of Texas MD Anderson Cancer Center, one of the original Gleevec trial leaders. A generic version, however, costs $400 in India.
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Family’s mission to raise profile of type one diabetes – BBC News
Posted: June 13, 2017 at 10:41 am
BBC News | Family's mission to raise profile of type one diabetes BBC News The family of a teenager who died from type one diabetes has made it "their mission" to raise the profile of the condition. Peter Baldwin, 13, from Cardiff, died in 2015, just days after he was diagnosed. His family are working closely with Diabetes UK ... Vigilance urged to detect type one diabetes Welsh campaign aims to raise awareness of type 1 diabetes in children Mum with two diabetic children is supporting a campaign to spot the signs |
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Why a key diabetes test may work differently depending on your … – CNN
Posted: June 13, 2017 at 10:41 am
This overestimate could lead a doctor to target a black patient's blood sugar levels aggressively, causing dangerously low blood sugar.
"I believe our study, for the first time, definitively shows there is a component of higher A1c that is due to biologic or genetic differences in glucose attaching to the red blood cell," said Dr. Richard Bergenstal, executive director of the International Diabetes Center in Minneapolis and lead author of the study.
The study notes that race only partially explains the hemoglobin A1c differences, and more research is needed to identify social and economic factors that may influence blood sugar levels in various groups of people.
For black patients in America, who have traditionally faced a history of barriers and disadvantages in health care, those factors might also include having limited access to care or medications.
Bergenstal offered one specific question that concerned patients could ask their doctors: "Are we depending just on the hemoglobin A1c to measure how my diabetes control is doing, or are we actually looking at the blood sugars to get a little better reflection of my blood sugars?"
He added that "the A1c, you know, is kind of an average marker, and no patient is average. One of our take-home messages is, it's probably time to be looking at blood sugars and personalizing therapy for each individual a little more than just this average blood sugar test."
In the US, type 2 accounts for about 95% of all diagnosed cases of diabetes. Type 1 diabetes, which occurs most often in children and young adults but can appear at any age, accounts for about 5%.
High hemoglobin A1c levels tend to correlate with complications, Bergenstal said.
"Glucose attaching on to proteins in the eye, kidney, nerve and blood vessels may be one way diabetes with high glucose is part of the cause of complications -- like blindness, kidney disease and nerve disease and amputations," he said.
The new study included data on 104 black patients and 104 white patients with type 1 diabetes. The data were taken from 10 diabetes centers across the US between October 2015 and January of 2017.
Bergenstal has received grants from and served on consulting/advisory boards for Abbott Diabetes Care, as well as other health-care companies, including Novo Nordisk, Becton Dickinson, Boehringer Ingelheim, Bristol-Myers Squibb/AstraZeneca, and Johnson & Johnson, during the conduct of the study.
The researchers found that the average hemoglobin A1c levels in black patients were higher than those in white patients, with a difference of about 0.8 percentage points. Based on the average glucose concentrations in the patients, however, the difference should have been only about 0.4 percentage points, the researchers found.
Yet the study came with limitations.
"We didn't study type 2, but I think there's no reason to think the pathophysiology or the chemistry of how glucose attaches to red cells is any different in type 2 than type 1," Bergenstal said.
"We just studied non-Hispanic African-Americans," he added. "We did not study Asians or Native Americans or Hispanics to see if there is a difference from whites, but we have a good model of how to test that in the future."
Other diabetes researchers also have called for more research, but not necessarily with a focus on race.
The new study calls for more focus on personalized medicine, taking into account a patient's ethnic background as well as other factors, said Dr. Alvin Powers, president of medicine and science for the American Diabetes Association and a professor at the Vanderbilt University School of Medicine.
"The A1c is an important measurement that the person with diabetes should know and should monitor with his or her health care provider, because if the A1c is elevated, your chance of having diabetes-related complications increases," said Powers, who was not involved in the new study.
"So, moving the A1c as close to the goal determined by the patient and his or her doctor is important, but this study shows that in interpreting the A1c, there may be some variation, whether an individual is of African-American descent or of Caucasian descent," Powers said.
Though interesting, the new study findings should be interpreted with caution and not necessarily be applied clinically until more research is conducted, said Dr. Leonard Egede, a professor of medicine at the Medical College of Wisconsin, who was not involved in the study.
"The key thing is that when you look at racial differences, we have social factors, clinical factors, and we also have what some people would consider genetic factors. I think the social and environmental factors are larger contributors to differences than the genetic factors," Egede said. "When you look at what they're describing, the idea that glucose variability may differ ... I don't think that's enough to neglect the fact that we actually have major issues around access to care, quality of care, access to medications."
He added that the study "should not detract from the core message we've been trying to get across to patients, which is that they need to take ownership of their disease, and they need to be very aggressive in their diet, their physical activity and taking their medication."
All in all, "these findings suggest next steps for the field," they wrote.
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Stabilizing diabetes: Old drug could help millions – Boston Herald
Posted: June 13, 2017 at 10:41 am
Dr. Denise L. Faustman is testing a cheap penny vaccine that could bring hope to millions struggling with Type 1 diabetes.
The researcher from Massachusetts General Hospital said BCG a vaccine used against tuberculosis thats been around since 1921 could reverse the deadly effects of the disease.
This offers hope for the first time that people with the long-standing disease will have long-term benefits, Faustman told the Herald last night. And to think its due to a cheap, 100-year-old generic drug.
Faustman has launched a five-year clinical trial using BCG on 150 people from all over the U.S. and seven slots are still open, she added.
BCG can reset the immune system to a normal state, she added. It can get you back to normal levels of blood sugar.
Type 1 diabetes, once called juvenile diabetes, affects people of all ages and can lead to blindness and fatal heart attacks and require amputations.
Its a mystery why diabetes, which is an autoimmune disease, pits the bodys immune system against itself, targeting the pancreas and destroying insulin-producing cells.
The possible answer, according to Faustman, is the bacillus Calmette-Guerin (BCG) or what she called a penny vaccine used all over the world. The vaccine was tested after World War I at the Paris Pasteur Institute.
Nows its making medical history again at the nonprofit Faustman Lab at Massachusetts General Hospital.
She presented her breakthrough this past weekend in San Diego, Calif., at the 77th Scientific Sessions of the American Diabetes Association.
Faustman said what excites her about her finding is that BCG is easily and inexpensively produced, even as the cost of treating Type 1 diabetes soars.
Its an old microorganism, she said.
Faustman hopes her five-year trial shows that using BCG over a long period of time will help stabilize the progression of the disease.
She said the vaccine which could also help with treating multiple sclerosis and Crohns disease, to name a few is a natural organism of the dirt.
Were putting back in people the environment they lost, she said, alluding to the Hygiene Hypothesis.
That theory links the lack of infection in early childhood to the rise in asthma and other similar diseases.
Using BCG resets the immune system to a normal state, Faustman explained. It doesnt cure the disease, but it makes it manageable.
What really matters for the MGH researcher is that the innovation was sitting before our eyes and she found it.
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Cost of insulin just one hurdle for seniors with diabetes – Pittsburgh Post-Gazette
Posted: June 12, 2017 at 4:40 pm
Pittsburgh Post-Gazette | Cost of insulin just one hurdle for seniors with diabetes Pittsburgh Post-Gazette Ms. Suvak, 68, is diabetic, one of an estimated 11.2 million seniors 25.9 percent of Americans 65 or older, according to the American Diabetes Association who have the condition that can result in serious infections as well as nerve, kidney and ... |
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Control diet, weight in diabetes fight – Appleton Post Crescent
Posted: June 11, 2017 at 3:40 pm
Patterns for diabetes often follow patterns for obesity.(Photo: Getty Images/iStockphoto)
Diabetes is a common medical condition affecting around 29 million Americans or about 1 in 11 adults. Diabetes is a metabolic condition manifested by elevated levels of sugar (glucose) in the blood stream. Diabetes is generally divided into type 1 and type 2.
Type 1 typically occurs in children or adolescents and can cause acute life threatening illness, and only about 5 percent of diabetics are type 1. Type 1 diabetics require insulin to survive.
Type 2 diabetes typically arises in adults and can be treated with diet and oral medications, but sometimes requires insulin. Type 2 diabetes tends to be linked to obesity, but not in every case.Recently, I wrote about the obesity epidemic in the U.S. I reported some CDC statistics that indicated the obesity rates are rapidly rising. Specifically, the data showed that no state had an obesity rate over 15 percent in 1985 and by 2016 no state had an obesity rate less than 20 percent. The overall obesity rate is about 33 percent. It is amazing to see how the U.S. diabetes rates are following the same patterns, but lagging behind by several years. In other words, as obesity rates increase in certain states, diabetes rates increase in a very similar pattern.
Currently, diabetes is diagnosed in an individual with fasting blood glucose of 126 or more. Some providers require two separate tests to confirm the diagnosis. People often refer to prediabetes when the blood glucose fasting is between 100 and 126. Prediabetics have a higher tendency to develop diabetes at a later time. Gestational diabetes refers to women who have elevated blood glucose during pregnancy. These individuals also have a tendency toward developing diabetes later in life.
The main symptoms of diabetes are thirst and frequent urination. However, in the early stages, there may not be symptoms. So, efforts are made to catch diabetes early and to try to prevent it. It is not uncommon to have screening done through Health Risk Assessments or regular office visits. People with risk factors such, as elevated blood pressure or elevated cholesterol, are advised to be screened.
Diabetes affects a number of systems. It is the No. 1 cause of kidney failure. In addition to the kidneys, diabetes affects the eyes, nerves (causing neuropathy), digestion, blood vessels and the immune system. Cardiovascular disease is a result of blood vessel disease and is the leading cause of death in diabetics. Immune system dysfunction makes diabetics more prone to infections making immunizations a priority. Much of the diabetic care is focused on controlling the blood glucose levels and reducing the other risk factors including high blood pressure, cholesterol and smoking. Blood glucose control reduces tissue damage and complications.
Glucose control is generally monitored through a blood test referred to as the glycohemoglobin or A1c. This test measures glucose that is attached to the hemoglobin in red blood cells. Red blood cells recycle about every two months so this measurement gives an indication of the average blood glucose over a two-month time period and is used to monitor treatment plans.
The best way to prevent diabetes and help control it is to be active and control diet and weight. It is advised to do at least 150 minutes of moderate exercise a week. Diet changes include avoiding simple sugars in food and drink, avoiding fatty foods and controlling portions to control weight all help.
Like obesity, diabetes is becoming more prevalent at a rapid pace. Diabetes management presents many challenges for patients and health-care providers. The best way to try to avoid diabetes is through diet, exercise and weight control. Stay healthy my friends.
Dr. Michael Shattuck is a family practice physician at ThedaCare Physicians-Wautoma.
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Methodist minister shares his diabetes story in memoir – Billings Gazette
Posted: June 11, 2017 at 3:40 pm
Diabetes isnt a funny subject.
But the Rev. Jeremy Scott treats the serious chronic disease with a light touch in the book hes written titled Rotten Hobby, A True Story of the Unspoken Epidemic Sweeping America.
In the 157-page paperback memoir, the software developer-turned ordained minister recounts his own journey with the disease in an effort to encourage others.
So this is my story, or part of it, at least, Scott writes early in his book. Some of it may be your story, too. If so, I want you to know one thing most of all: You are not alone.
He calls diabetes a rotten hobby, one that is assigned by fate.
Like the universe just declared: You will be a Green Bay Packers fan, but you dont live in the Midwest and you dont like cheese! he adds. Though, that might be worse, now that I think about it.
Scott, 39, serves as the vital-congregations developer for the Mountain Sky Area of the United Methodist Church. He lives in Billings with his wife, Daen, and their two children.
Daen Scott, a nurse practitioner who specializes in endocrinology, works with diabetes patients. She provided the medical expertise for the book and has a with credit on the books cover.
In an interview at his office, Scott tells how just out of college at age 24, he was hired for his first professional job as a software engineer in Albuquerque, New Mexico. The job came with health insurance, and Daen Scott insisted the pair get physicals.
Being the typical man I thought, I feel fine. I dont need to go to the doctor, he said.
But Scott went, and much to his dismay, he learned that the blood sugar in his urine was way out of whack. When he returned for a blood test, his A1C level was 13.5.
Which is way more than it should be, he said. The average for normal people is 6.
Diagnosed with type 2 diabetes, Scott knew his grandfather had the disease, though he rarely talked about it. Scott initially didnt think it would be a big deal.
But then he attended a nutrition class.
Eating is a big part of my life. I love food. I love cooking, Scott said. Its definitely my go-to for stress relief. I dont smoke, I dont do drugs I eat cheese steak.
Hes also a big fan of regular soft drinks, Coke in particular. When the dietitian told Scott he had to limit carbs to 60 grams per meal, he knew his days of drinking 12-ounce cans of pop that totaled 39 grams each were over.
Trying to find time to exercise was difficult because much of Scotts time at work was spent in front of a computer. He traveled 45 weeks a year, which made smart eating a challenge.
And he started taking medication, which last year grew to include insulin injections. That affected one of his longtime dreams.
Its hard to get your pilots medical certificate if youve got insulin in your diabetes regimen, Scott said. And learning to fly has always been a goal of mine.
In the book he recounts how a trip for his company to Louisiana in 2005 sent his career in a new direction. In the aftermath of Hurricane Katrina, Scott went to New Orleans to help with a vaccination program.
Despite working 20-hour days in the midst of tragedy, he felt like he was doing something valuable.
I remember standing at a window and praying about the week and feeling Id done something important, but I felt completely inadequate, there was so much to do, Scott said. I was asking God whats your plan here, how are you going to make this right?
And Scott felt God nudge him, remind him that he was there and he was part of the solution to help the survivors. He went home to a job he enjoyed, but Scott decided to pursue a new path.
He and his family moved to Columbus, Ohio, where he attended Methodist Theological School and served a church for two years. He graduated from the seminary in 2010, before moving to Billings.
Scott led Evangelical United Methodist Church for four years and then in 2014, he accepted his present assignment. In December, Scott took a one-month renewal leave.
He decided to take on a project.
I had been feeling like I wanted to talk about my life of having diabetes because I didnt see anybody else doing it, he said. And the numbers are so huge: 30 million Americans have it, and Id read a lot of great books that people write about their lives but Id never seen one like this.
He wasnt sure if he wanted to shoot videos for a YouTube channel or write a series of blog posts. So he started writing down his thoughts and before he knew it, he had an outline for a book.
Scott felt that in the national debate over health care and insurance coverage, a stigma was attached to chronic diseases, including diabetes. Health care can cost more for people with chronic medical conditions, and politicians, including Rep. Mo Brooks of Alabama, put the blame for the conditions on the patients.
Brooks, in May, was quoted as saying that people who lead good lives wouldn't have to deal with pre-existing conditions.
Theres still a lot of shame associated with diabetes, in the sense that if you have it, you must somehow deserve it, Scott said. If you just eat a little better or exercise a little more, you wouldnt have it.
No one chooses a disease like diabetes, he said, and genes can also play a role. Scott shares a deep level of honesty with readers, telling of his struggles with the disease, and even talks briefly about erectile dysfunction.
He ran everything he'd written by his wife and a couple other friends, to make sure he wasnt over-sharing.
As a pastor, I feel I have a calling to live a more open and transparent life and if not me, than who? Scott said.
At the end of the book, he includes a three-page small-group reading guide. Scott hopes churches might consider reaching out to people with the chronic condition who feel isolated and alone.
Faith plays a part in his battle with the disease.
Im not one who says God gave me diabetes, Scott said. But I do see it as somewhat of a cross given to me to bear, and I want to do that in a way that gives hope to others. Thats what my faith calls me to do.
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Study Shows Texting Could Help Type 2 Diabetes Management – NBC 7 San Diego
Posted: June 10, 2017 at 3:43 am
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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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Lexicon diabetes pill hits endpoint in another phase 3, teeing up regulatory filings by partner Sanofi – FierceBiotech
Posted: June 10, 2017 at 3:43 am
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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