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.

Related:

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.

Related:

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.

Related:

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.

Read more:
Cancer Drug Gleevec Might Slow Type-1 Diabetes - NBCNews.com

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.

Read more:
J&J diabetes drug shows heart benefit in large safety study - Reuters

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 diabetesBBC News Welsh campaign aims to raise awareness of type 1 diabetes in childrenGP online Mum with two diabetic children is supporting a campaign to spot the signsSouth Wales Argus WalesOnline all 5 news articles »

See the original post:
Family's mission to raise profile of type one diabetes - BBC News

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.

The rest is here:
Why a key diabetes test may work differently depending on your ... - CNN

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.

Continued here:
Stabilizing diabetes: Old drug could help millions - Boston Herald