Inhalable insulin for diabetes wins FDA approval

imagesThe Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.

The FDA cleared MannKind Corp.’s drug Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes that affects more than 25 million Americans. The approval decision comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In Type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes of starting. MannKind has said patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals.

The FDA approved the drug with a boxed warning — the strongest type — indicating that the drug should not be used in patients with chronic lung diseases, such as asthma, due to reports of breathing spasms.

Demand for diabetes treatments are surging globally as the prevalence of obesity explodes. Roughly 347 million people worldwide have the disease, according to the World Health Organization.

New effort to fight diabetes in Sonoma County

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Sonoma County medical providers are taking aggressive steps to deal with the high rate of patients with diabetes admitted to local hospitals, a trend that is said to be driving up hospital costs.

In Sonoma County, patients with diabetes account for almost 26 percent of all local hospital admissions, according to a recent UCLA analysis of 2011 hospital patient discharge data. That’s a total of 7,459 hospital admissions.

The added cost of hospital care is estimated at $16.4 million, according to the study, which was conducted by the UCLA Center for Health Policy Research with support from the California Center for Public Health Advocacy.

“We are very concerned about the epidemic of diabetes and the toll that it takes on individuals and the system that cares for them,” said Karen Holbrook, the county’s deputy public health officer.

Holbrook said diabetic patients who are admitted to local hospitals pose more medical complications than those who are not diabetic and often require more tests and treatments. Severe diabetes often results in serious medical conditions such as liver disease and kidney failure, she said.

According to the UCLA study, 31 percent of the state’s hospitalized patients 35 years or older, the age group that accounts for most hospitalizations, had diabetes. The study estimated that the added cost to hospitals in California was $1.6 billion. Hospital stays for diabetic patients in the state cost an average of $2,200 more than for non-diabetic patients, according to the study.

The study’s authors pointed out that 75 percent of this care is covered by Medicare and Medi-Cal, the state’s Medicaid program. Medi-Cal alone pays $254 million in added costs for diabetic patients.

The Tour de Cure event hosted by the American Diabetes Association of Northeast Ohio has already raised $250,000 for diabetes research

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CUYAHOGA FALLS — The Tour de Cure event hosted by the American Diabetes Association of Northeast Ohio has already raised $250,000 for diabetes research in the region, according to Melissa Sutton, the event manager.

The annual event leads riders through a bike route as long as 100 miles. However, riders could also bike shorter distances.

The Saturday ride kicked off at the Cuyahoga Valley Christian Academy on Wyoga Lake Rd. in Cuyahoga Falls.

Participants could also enjoy on-site activities geared towards fun and information about diabetes.

Sutton, who has lived with type one diabetes since she was 9-years-old, says she hopes the ride will combat the stigma the disease faces. “My pancreas stopped working and there’s not a darn thing I can do about it,” Sutton tells Channel 3’s Hilary Golston. “It stops working. So I take it particularly personally when people think it’s a lifestyle disease.”

According to the ADA, 330,000 people have diabetes in Northeast Ohio. “Red riders” or those living with the disease donned red shirts to denote they have diabetes and are participating in the race.

Riders were asked to raise at least $200 to participate, but some raised much more. 11-year-old Gabe Grizwald was able to rake in $2,000. He’s also living with type one diabetes. “I ride for diabetes because it’s just a horrible disease to have and it’s really just changed my life and I think it helps so much when people ride for us and raise money and it really could lead to a cure,” Grizwald tells Golston.

Brian Travalik is Tour de Cure’s red rider ambassador. Decked out in a tutu for flare, he not only lives with diabetes, but represents the so-called “red riders.” Red riders are those who have diabetes and are also participating in Tour de Cure. “It’s a chance to be honored as a hero,” Travalik said. “To see other people with diabetes, it’s a good feeling to be around that comradery of other people that are dealing with that same disease.”

It’s not too late to donate to the cause. You can head over to http://main.diabetes.org/site/TR?fr_id=9375&pg=pfind to give.

 

Human gut cells turned into insulin producers may treat diabetes

Scientists have converted human gut cells into insulin producers by turning off a single gene in an experiment that suggests a novel way forward in treating diabetes.

Using a miniature model of the human intestine, only a few millimeters in size and made from stem cells, the scientists deactivated a gene in the cells tied to metabolic regulation called FOXO1. Once disabled, the cells began producing insulin.

The method, described Monday in the journal Nature Communications, raises the possibility of replacing insulin- making pancreatic beta cells lost in diabetics by using a drug to retrain patients’ existing cells. While progress has been made in generating beta cells from stem cells, the method hasn’t yet produced ones with all the needed functions, said Domenico Accili, the study’s lead author. Plus, such cells would require transplantation.

“We provided a proof of principle that we can do this in human tissues and are also very excited that there is a single identifiable target to trigger this process,” Accili, professor of medicine at Columbia University’s Naomi Berrie Diabetes Research Center in New York, said in an interview. “This is what the pharmaceutical industry is interested in — make a chemical and do what we did in test tubes to administer to persons with diabetes and teach their gut cells to become beta cells.”

The results build on research two years ago by Accili and his team that first tested the approach in mice, successfully converting gut cells into insulin-making cells. In the human cell experiment, the gut cells started releasing insulin after seven days and only in response to insulin.

Now that Accili and his team have shown it works in human cells, their next step is to develop a drug to test in people. Accili said it’s possible that there could be a compound for clinical trials in a year or two.

Diabetes, which results when the body doesn’t use insulin properly or doesn’t make the hormone, is the seventh-leading cause of death in the U.S. Insulin is a hormone secreted by the pancreas that helps the body control blood sugar.

Destruction of insulin-making beta cells in the pancreas is the central feature of Type 1 and Type 2 diabetes. In Type 1 diabetics, the pancreas are destroyed by the immune system and don’t produce insulin. In Type 2, in which the body doesn’t use insulin properly, beta cells become progressively dysfunctional.

One advantage to this experimental approach is that the gastrointestinal tract is partly protected from attack by the immune system, making gut cells less susceptible to destruction, Accili said.

A treatment for diabetes that doesn’t require daily insulin injections would change the treatment landscape for the 29 million diabetics in the U.S. However, it’s likely that any potential drug would first be evaluated for Type 2 diabetes, because of concerns of testing in Type 1 diabetics going without insulin injections, he said.

“The work is a laser-like focus on turning this into a treatment,” Accili said. “We follow 3,000 patients with Type 1 at the Berrie Center alone. That’s our main goal.”

Collaborations with drugmakers are already under way, Accili said, though he declined to name companies.

British drugmaker AstraZeneca Plc helped fund the research, with the National Institutes of Health, the Manpei Suzuki Diabetes Foundation, the Swedish Society for Medical Research, the Japan Society for the Promotion of Science, the JPB Foundation and the Brehm Coalition.

June 30, 2014 ~ Ginger Vieira, Dealing with Diabetes Burnout

photo2Ginger Vieira

Author of Your Diabetes Science Experiment and Emotional Eating with Diabetes, Ginger Vieira has lived with Type 1 diabetes and Celiac disease since 1999, and fibromyalgia since early 2014. Today, she is an avid freelance writer and motivational speaker with a background as a certified cognitive coach, personal trainer, and Ashtanga yoga instructor specializing in coaching people with diabetes. She creates diabetes video blogs at her YouTube Channel and produces regular freelance content for various diabetes websites including DiabetesDaily.com and ASweetLife.org. In 2009 and 2010, Ginger set 15 records in drug-tested powerlifting with her best lifts including a 308 lb deadlift, 190 lb. bench press, and a 265 lb. squat. Today, she lives in Vermont with three dogs and her fella. Living-in-progress.com

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Listen to the latest broadcast of Diabetes Living Today®:  June 3o, 2014 ~ Ginger Vieira on Dealing with Diabetes Burnout.

 

FDA studies possible pre-cancerous link with diabetes drugs!

The Food and Drug Administration is studying unconfirmed reports that a widely used class of diabetes drugs, which includes Merck & Co’s Januvia, may cause inflammation of the pancreas and pre-cancerous changes to the pancreas.

The agency, in a notice on its website on Thursday, said this is the first time it has communicated potential pre-cancerous links to the medicines, known as incretin mimetics.

The drugs for type 2 diabetes also include Victoza from Danish drugmaker Novo Nordisk and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc.

Patients should continue taking their medicines as directed until speaking with healthcare professionals, the agency said. The FDA said it is investigating findings from academic researchers that highlighted the potential risk.

“These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes,” the agency said.

The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.

In the meantime, the FDA said it has not reached any new conclusions about safety risks of the class of drugs.

The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.

“It’s too early to tell, but we’ll keep an eye on it,” Edward Jones analyst Judson Clark said, when asked about the significance of the potential safety issues in Thursday’s FDA advisory.

But Clark said he did not expect any immediate changes in prescribing habits for the drugs because the pancreatitis risk is already noted on the drug labels.

The class of medicines, which mimic a natural hormone called incretin, prompt the pancreas to release insulin when blood sugar is rising. They are approved to treat type 2 diabetes, the most common form of diabetes which usually develops in adulthood and is closely linked to obesity.

Merck’s Januvia and its related drug, Janumet, had combined sales last year of almost $6 billion, making them by far the company’s biggest product franchise. Onglyza and a related drug called Kombiglyze had sales last year of $709 million.

Shares of Merck were down 1.1 percent at $44.08, while Bristol-Myers shares were down 0.8 percent at $38.18 on Thursday afternoon on the New York Stock Exchange. Shares of AstraZeneca were up 1 percent at $46.31, also on the NYSE. Novo Nordisk shares closed down 1 percent in Copenhagen.

Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk

Diabetes drugs sold by Merck & Co. (MRK) and Bristol-Myers Squibb Co. (BMY) may double a user’s risk of developing an inflammation of the pancreas linked to cancer and kidney failure, an analysis of insurance records shows.

Patients hospitalized with pancreatitis were twice as likely to be taking Januvia, Merck’s top-selling drug, or using Bristol-Myers’s Byetta, than a control group of diabetics who didn’t have pancreatitis, according to the analysis today in the journal JAMA Internal Medicine. Both drugs increase GLP-1, a hormone that stimulates insulin production from the pancreas.

Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the U.S. Food and Drug Administration said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. The study, which analyzed data from 2005 to 2008, showed a doubling in pancreatitis cases.

“This is the first real study to give an estimate of what the risk is, until now we just had a few case reports,” said Sonal Singh, the study’s author and an assistant professor of medicine at Johns Hopkins University in Baltimore. “These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit.”

Merck, the second-largest U.S. drugmaker, reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year for Whitehouse Station, New Jersey-based Merck.

Novo’s Victoza

Bristol-Myers, based in New York, acquired Byetta when it bought Amylin Pharmaceuticals last year for about $5 billion. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011.

“Bristol-Myers Squibb and AstraZeneca are confident in the positive benefit-risk profile of Byetta and Bydureon as demonstrated by extensive clinical trial data and safety surveillance data,” Ken Dominski, a Bristol-Myers spokesman, said in an e-mail. The companies “will continue to carefully monitor any post-marketing reports of acute pancreatitis.”

AstraZeneca Plc (AZN), based in London, has a partnership with Bristol-Myers on diabetes treatments. Bydureon is a longer acting version of Byetta.

Other drugs that increase the level of GLP-1 in the body include Bristol-Myers’s Onglyza and Novo Nordisk A/S (NOVOB)’s Victoza. The analysis only looked at Januvia and Byetta because the other treatments weren’t on the market during the study period. Januvia was approved in the U.S. in 2006, and Byetta in 2005.

Pancreatic Cancer

Singh said long-term studies should be done to determine if GLP-1 therapies also increase the risk of pancreatic cancer.

“We really need to know more about these drugs as pancreatitis is on the pathway to pancreatic cancer,” he said.

Merck said it has thoroughly reviewed preclinical, clinical and post-marketing safety data and found “no compelling evidence of a causal relationship between” the active ingredient in Januvia and pancreatitis or pancreatic cancer.

“Nothing is more important to Merck than the safety of our medicines and vaccines and the patients who use them,” Pam Eisele, a company spokeswoman, said in a statement.

Diabetes Patients

In diabetics, pancreatitis occurs in about 3 in 1,000 patients. A doubling of that risk, such as that seen in the study, would drive that number to 6 in 1,000 for patients taking Byetta or Januvia, Singh said. About 8.6 percent of Americans, or 25 million people, had diabetes in 2010, according to data compiled by Bloomberg. The number may rise to more than 34 million by 2020.

The study looked at 1,268 diabetics who had been hospitalized with pancreatitis and compared them to the same number of patients who didn’t have the condition. Among those with pancreatitis, 87 had filled a prescription for Byetta or Januvia compared with 58 in the control group. When adjusting for variables that can make a patient more likely to develop pancreatitis, the researchers determined there was a doubling of risk, Singh said.

The study was funded by grants from Johns Hopkins, the National Center for Research Resources, and the National Institutes of Health Roadmap for Medical Research.

To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Study Identifies Possible Protective Blood Factors Against Type 2 Diabetes

BRONX, N.Y., May 3, 2012 /PRNewswire via COMTEX/ — Researchers at Albert Einstein College of Medicine of Yeshiva University in collaboration with Nurses’ Health Study investigators have shown that levels of certain related proteins found in blood are associated with a greatly reduced risk for developing type 2 diabetes up to a decade or more later. The findings, published today in the online edition of Diabetes, could open a new front in the war against diabetes.

These proteins are part of what is called the IGF axis. This axis was named for insulin-like growth factor-1, (IGF-1), so called because it has biological effects similar to those of insulin (the hormone that regulates blood glucose levels) but has a greater effect on cell growth than insulin. The researchers also looked at levels of several proteins known as IGF binding proteins, or IGFBPs, that may have strong effects independent of IGF-1.

Researchers have hypothesized that the IGF axis may influence risk for developing diabetes – an idea supported by laboratory and mouse studies, and a few initial studies in humans. However, the current study is the first large, prospective investigation of several components of the IGF-axis and the risk for developing diabetes, according to co-senior author Howard Strickler, M.D., M.P.H., professor of epidemiology & population health at Einstein.

In the current study, the researchers analyzed levels of IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 in blood taken from 742 women in the Nurses’ Health Study who years later developed type 2 diabetes as well as a similar number of women in the study who did not develop diabetes. None of the women had any signs or symptoms of the disease at the time their blood samples were taken. The median time between the taking of blood samples and diabetes onset was nine years.

Each component of the IGF axis (IGF-1 and IGFBP-1, -2, and -3) had a significant independent association with diabetes risk – most notably IGFBP-1 and -2. Compared with women in the bottom 20 percent with respect to their levels of IGFBP-1, having high levels of IGFBP-1 (top 20 percent) was associated with a three-fold reduction in risk for diabetes, while high levels of IGFBP-2 were associated with a more than five-fold reduction in diabetes risk.

“Our data provide important new evidence that circulating IGF-axis proteins may have a role in the development of type 2 diabetes,” said Dr. Strickler.

The findings have potential clinical implications. First of all, IGF-axis proteins could help in stratifying people at risk for diabetes. “For example,” said Dr. Strickler, “we know that obesity is a major risk factor for diabetes. But some overweight individuals don’t develop diabetes, while some thin people do. If our findings are confirmed, they could help doctors more precisely determine who is actually at risk for the disease.”

The proteins may also prove useful as targets for novel therapies to prevent or treat diabetes. But Dr. Strickler cautions that it’s too early to apply these findings to clinical practice. “IGF-axis proteins have other effects, some beneficial and some not,” he notes. “We need to learn more about the connection between the IGF-axis and diabetes before we recommend that people get tested for these substances, and before deciding how we can exploit the IGF-1 axis to help address diabetes.”

The Diabetes paper is titled, “The Insulin-Like Growth Factor Axis and Risk of Type 2 Diabetes in Women.” The first author was Swapnil Rajpathak (who was at Einstein at the time this work was conducted). The other senior author is Frank B. Hu, M.D., Ph.D, of Harvard School of Public Health, Boston, MA. Additional contributors include Meian He, M.D., Ph.D., (Harvard and Huazhong University of Science and Technology, Wuhan, Hubei, China); Qi Sun M.D., Sc.D., (Harvard); Jeannette Beasley, Ph.D., R.D., M.P.H., (Fred Hutchinson Cancer Research Center, Seattle, WA); Michael Pollak, M.D., (McGill University, Montreal, Quebec, Canada); and Robert Kaplan, Ph.D., Radhika Muzumdar M.D., M.B.B.S., Thomas Rohan, M.D., Ph.D., Mimi Kim, Sci.D., Jeffrey Pessin, Ph.D., and Judith Wylie-Rosett, Ed.D., all of Einstein. Co-author Marc Gunter, Ph.D., contributed to the paper while at Einstein.

The study was supported by grants from the National Institutes of Health. Laboratory testing and data analysis were supported in part by NIDDK 5-R01-DK-080792. The NHS is supported by grants CA-87969, DK-58845, and DK-58785 from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development. Q.S. was supported by a career development award (K99HL098459) from the National Heart, Lung, and Blood Institute. The authors report no conflicts of interest.

About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nation’s premier centers for research, medical education and clinical investigation. During the 2011-2012 academic year, Einstein is home to 724 M.D. students, 248 Ph.D. students, 117 students in the combined M.D./Ph.D. program, and 368 postdoctoral research fellows. The College of Medicine has 2,522 full time faculty members located on the main campus and at its clinical affiliates. In 2011, Einstein received nearly $170 million in awards from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Through its extensive affiliation network involving Montefiore, Jacobi Medical Center – Einstein’s founding hospital, and five other hospital systems in the Bronx, Manhattan, Long Island and Brooklyn, Einstein runs one of the largest post-graduate medical training programs in the United States, offering approximately 155 residency programs to more than 2,200 physicians in training. For more information, please visit www.einstein.yu.edu and follow us on Twitter @EinsteinMed.

SOURCE Albert Einstein College of Medicine

Copyright (C) 2012 PR Newswire. All rights reserved

 

Sanofi iBGStar® Blood Glucose Monitoring System Now Available in the U.S.

– First FDA Cleared Blood Glucose Meter that Connects Directly to iPhone® and iPod touch® – – Available at Apple® Retail Stores and Walgreens Nationwide, Online at Apple.com, Walgreens.com and through Diabetic Care Services – – Recipient of Two Design Awards for Outstanding Product Design –

BRIDGEWATER, N.J., May 2, 2012 /PRNewswire via COMTEX/ — Sanofi US announced today that the iBGStar® Blood Glucose Monitoring System, consisting of the iBGStar® blood glucose meter and iBGStar® Diabetes Manager App, is commercially available in the U.S. iBGStar® is the first Food and Drug Administration (FDA) cleared blood glucose meter that directly connects to the iPhone® and iPod touch®, offering accurate blood glucose monitoring that seamlessly integrates into the lives of people with diabetes. iBGStar® is available for purchase at Apple® Retail Stores and all Walgreens stores nationwide, online at Apple.com, Walgreens.com and through Diabetic Care Services.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/46108-sanofi-ibgstar-blood-glucose-monitoring-system

“Many people with diabetes today rely both on their iPhone® or iPod touch® and blood glucose monitors as important parts of their daily lives,” said Naina Sinha, MD, an in-patient diabetes attending physician and assistant professor of medicine at a leading academic medical center and university in New York City. “By combining these two essential tools, iBGStar® makes it possible to provide blood glucose tracking, monitoring and reporting together in a new way.”

About iBGStar®When iBGStar® is directly connected to an iPhone® or iPod touch® and used with the iBGStar® Diabetes Manager App, blood glucose results are presented on the Multi-Touch display quickly after monitoring.

iBGStar® can also be used independently to measure blood glucose levels; results can be synchronized later to an iPhone® or iPod touch®. iBGStar® and BGStar® Blood Glucose Test Strips, which are used with iBGStar®, are available at all Walgreens stores nationwide and online at Walgreens.com and through Diabetic Care Services. These test strips may be covered under certain health insurance plans so individuals should check directly with their provider.

The iBGStar® Diabetes Manager App has a range of features and multiple views for analyzing glucose patterns on-the-go. Visual graphs and statistics can help people record and track their readings, carbohydrate intake, insulin doses (if taking insulin) and more. Color-coded scorecards show individual monitoring results for easy identification of high or low blood glucose levels. A ‘share’ function allows specific data to be sent via e-mail to caregivers and/or healthcare teams. The iBGStar® Diabetes Manager App is available for free from the App Store on iPhone® and iPod touch® or at www.itunes.com/appstore .

“Sanofi is pleased to launch iBGStar®, which expands our diabetes portfolio as we pursue comprehensive disease management offerings and further illustrates our commitment to developing innovative solutions that help improve the lives of people with diabetes,” commented Dennis Urbaniak, Vice President, Head of U.S. Diabetes, Sanofi US. “The iBGStar® Blood Glucose Monitoring System will help people living with diabetes check their blood sugar and communicate with their healthcare teams, using mobile technologies that have become central to so many people’s lives.”

In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring solutions. iBGStar® is a result of this agreement.

iBGStar® received the Good Design(TM) Award in 2011 for outstanding product design in the medical category from the Chicago Athenaeum of Architecture and Design and the European Centre for Architecture Art Design and Urban Studies. Additionally, iBGStar® received the red dot design award in 2011 for outstanding product design in the life science and medicine category. The red dot design award is one of the most renowned international design competitions ( www.red-dot.de/presse ), with almost 14,000 entries from 68 countries in 2010 alone. Winners are considered to be the best design in the industry worldwide.

Apple®, iPhone® and iPod touch® are trademarks of Apple Inc, registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Content purchased from the iTunes Store is for personal lawful use only. Don’t steal music.

For more information, visit www.ibgstar.us .

About the Sanofi Diabetes DivisionSanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.

Important InformationThe iBGStar® meter and lancing device are for single patient use. Do not share them with anyone including other family members. Do not use on multiple patients. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris /quotes/zigman/187275 FR:SAN +0.97% and in New York /quotes/zigman/307926/quotes/nls/sny SNY +0.16% .

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Forward Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

US.BGM.12.02.076

SOURCE Sanofi US

Copyright (C) 2012 PR Newswire. All rights reserved

 

Kid’s Type 2 Diabetes Difficult to Treat

Type 2 diabetes was once considered an adult disease. Not so anymore. Kids are being diagnosed at an alarming rate, and now a new study says that these children are going to have a tougher time getting the disease under control.

Obesity and lack of physical activity are two of the most common reasons someone gets type 2 diabetes. During the past three decades, the tripling of obesity in children has gone hand in hand with an increase of type 2 diabetes in children.

What is type 2 diabetes? It begins when the body develops a resistance to insulin and cannot use insulin properly. The pancreas is no longer able to produce sufficient amounts of insulin to control blood sugar. Hyperglycemia is the medical term for high blood sugar levels. The reason it is so bad is that hyperglycemia can damage the vessels that supply blood to vital organs, which can increase the risk of heart disease and stroke, kidney disease, vision problems, and nerve problems.

In a large new trial looking at ways to slow the progression of type 2 diabetes in children and teens, the addition of a second drug to the mainstay treatment metformin was only marginally more effective at controlling blood sugar than metformin alone.

Within a year, on average, half of kids on metformin and some 40 percent taking both metformin and rosiglitazone (Avandia) ended up having to resort to insulin injections to control their blood sugar, researchers reported Sunday at the annual meeting of the Pediatric Academic Societies in Boston and in the New England Journal of Medicine online.

“The results of the study were discouraging,” said Dr. David Allen from the University of Wisconsin School of Medicine and Public Health in an NEJM editorial. “These data imply that most youth with type 2 diabetes will require multiple oral agents or insulin therapy within a very few years after diagnosis.”

All 699 children included in the study had been diagnosed with type 2 diabetes two years or less before enrollment, so the rapid advance of about half to needing insulin marks an early start to a potential lifetime of complications and side effects — from the diabetes itself and the medications used to treat the disease.

Type 2 diabetes “progresses more rapidly” in youth, according to Dr. Phil Zeitler from the University of Colorado, Denver, who worked on the new study.

He and his colleagues were surprised at how quickly many of the youngsters needed to switch from oral medications to taking daily insulin shots, Zeitler told Reuters Health.

Also, Zeitler said, the teens in the study appeared to have complications, including infections and hospitalization, more often than adults do.

All the children in the study were overweight or obese, and ranged in age from 10 to 17 years old.

Children also may have a more difficult time taking their medications as instructed and are not usually in control of what is given to them to eat. Fast food dining has become a staple for many American families. School lunches are not much better in some regions, and kids are simply not as active as in past generations. Zeitler noted “the toxicity of your lifestyle must be pretty severe,” for young children and teens to get type 2 diabetes before adulthood.

That’s why all of the kids in the study got at least “basic lifestyle counseling,” he emphasized — for example, advice to stop drinking sugared sodas, eat less fast food, watch their diet in other healthy ways, take stairs instead of elevators and generally get more exercise.

Study enrollment began in July 2004 and follow-up continued through February 2011. All the kids in the study were taking metformin, a well-established diabetes drug, and a third were assigned to take the newer drug Avandia as well.

Another third of the kids were assigned a very intensive “lifestyle intervention,” that involved more assignments for kids to complete, more interaction with counselors, and close involvement of at least one parent, in addition to taking metformin.

The kids’ treatments were deemed failures if blood sugar and other signs pointed to their diabetes not being under control for a period of six months or more.

In the end, 52 percent of kids on metformin alone “failed” treatment, along with 39 percent of kids on metformin and Avandia and 47 percent of kids on metformin and lifestyle changes.

The median time it took for blood sugar control to be lost was just under a year.

The added benefit of Avandia was limited to girls, for reasons that are unclear, the researchers reported.

Also for unknown reasons, they noted, metformin alone was less effective for non-Hispanic black participants than other kids.

Overall, 19 percent of the participants developed serious adverse effects such as severe hypoglycemia, diabetic ketoacidosis and lactic acidosis.

The rate in the treatment groups was 18 percent in the metformin-only group, 15 percent in the double-drug group and 25 percent in the group that received the very intensive lifestyle intervention. The rate of specific problems such as hyperglycemia, were not significantly higher between the groups.

Fifty years ago,” the editorial continues, “children did not avoid obesity by making healthy choices; they simply lived in an environment that provided fewer calories and included more physical activity for all. Until a healthier ‘eat less, move more’ environment is created for today’s children, lifestyle interventions like that in the …study will fail.”

Type 2 diabetes can be difficult to diagnose in children because they may go without symptoms for a long time. A blood test to measure glucose metabolism is needed for an accurate diagnosis.

Mayoclinic.com gives these symptoms to be aware of.

– Increased thirst and urination. As excess sugar builds up in your child’s bloodstream, fluid is pulled from the tissues. This may leave your child thirsty. As a result, your child may drink — and urinate — more than usual.

– Increased hunger. Without enough insulin to move sugar into your child’s cells, your child’s muscles and organs become depleted of energy. This triggers hunger.

– Weight loss. Despite eating more than usual to relieve hunger, your child may lose weight. Without the energy sugar supplies to your cells, muscle tissues and fat stores simply shrink.

– Fatigue. If your child’s cells are deprived of sugar, he or she may become tired and irritable.

– Blurred vision. If your child’s blood sugar is too high, fluid may be pulled from the lenses of your child’s eyes. This may affect your child’s ability to focus clearly.

– Slow-healing sores or frequent infections. Type 2 diabetes affects your child’s ability to heal and resist infections.

– Areas of darkened skin. Areas of darkened skin (acanthosis nigricans) may be a sign of insulin resistance. These dark patches often occur in the armpits or neck.

Treating type 2 diabetes is much more difficult than preventing it. Long-term diabetes can have devastating results on your health. That’s why it’s so important for families to be aware of the disease and what it takes to help prevent it.

Sources: http://www.mayoclinic.com/health/type-2-diabetes-in-children/DS00946/DSECTION=symptoms

http://www.reuters.com/article/2012/04/30/us-diabetes-kids-idUSBRE83T17K20120430