Diabetes Alert: Actos Linked To Bladder Cancer

After Avandia, it is now the turn of Actos to be linked to life-threatening conditions. On September 17 the United States Food and Drug Administration announced it is reviewing the link between use of the diabetes drug Actos or pioglitazone and elevated risk of bladder cancer among patients with type 2 diabetes mellitus who were using the medication.

The FDA said an analysis of data collected during a 5-year period from an ongoing 1o-year observational study conducted by the manufacturer, Takeda Pharmaceuticals North American Inc in San Diego showed overall there was no significant association between use of Actos and increased risk of bladder cancer among diabetes mellitus patients. Apparently, those who used Actos were 20 percent more likely to be diagnosed with the cancer, but the increase was deemed statistically insignificant.

The FDA acknowledged the risk of bladder cancer was found significantly higher among those who had either been using Actos for more than two years or had had a highest accumulative dose of this medication.

The health regulator did not say how higher the risk it was among those patients at risk. Instead, it advised doctors should continue following the current recommendations to prescribe Actos and patients would take the drug as prescribed. If they have any concern or worry, they should talk to a medical professional.

At this time, the agency stressed it has not concluded that it is Actos that caused the increase in the risk of bladder cancer among patients who either used the drug for more than 2 years or those whose accumulative intakes of this drug over the years were the highest.  It will inform the public of further information on the safety issue when it has become available, probably within a few months.

Based on the information released by the FDA, it is possible that Actos increases the risk of bladder cancer among the diabetes mellitus patients, a health observer suggested.

The FDA cited preclicnical carcinogenicity studies of Actos saying male rats receiving doses of the drug that were equivalent to what diabetes patients receive were at higher risk of bladder cancer.  Also, two 3-year controlled clinical studies of Actos showed patients who used Actos were at higher risk of bladder cancer compared to those who used other medications.

The FDA said these data have been included in the Actos drug label as precautions. But it does not mean that Actos as the cause increases the risk of this malignancy.

The health observer, who did not want to be named, cautioned the patients included in the analysis took Actos for a period between 0.2 and 8.5 years.  He said although the overall risk was not significant higher in the whole population, the risk differed among individuals. That is why those who had taken the Actos for more than 2 years and those who had highest accumulative doses were at greater risk.

Actos was approved July 15, 1999 as an adjunct to diet and exercise to control blood sugar in adults with type 2 diabetes mellitus.  Studies suggest Actos does not increase as much heart risk as its competitor known as rosiglitazone or Avandia, which is made by GlaxoSmithKline.  Rosiglitazone was found twice as likely to suffer heart attack as Actos.

One type of heart risk - heart failure - has been recognized by the FDA, which in Aug 2007 required a boxed warning, the highest grade of warning, to alert patients and medical practitioners that pioglitazone may cause or exacerbate heart failure in certain patient populations.

Red meat, processed meat, soft drinks, eggs, fruit juice, and arsenic in drinking water have been associated with an increased risk of type 2 diabetes mellitus, while coffee consumption, brown rice, vitamin d, exercise, plant-based diet, omega-3 fatty acids, garlic, fish, turmeric, micronutrients like selenium, vitamin e, vanadium, and chromium, soy products, Mediterranean diet, L-carnitine, and black tea may help reduce the risk or actually prevent the disease.

Thank you David Liu

Diabetes and Hearing Loss

Diabetics are more than twice as likely as those without the disease to have hearing loss, according to a recent US National Institutes of Health (NIH) study, and which can be fully corrected in 95% of all cases.

Indeed, hearing loss is one of the many problems experienced by diabetics, which are often put down to ‘just getting on a bit’ rather than being linked to their diabetes. Actually Type 2 diabetes and hearing loss have been medically linked for many years, and it is recommended that diabetics should have regular hearing tests as part of their routine screening.

The hearing loss experienced by diabetics has different causes and characteristics from the hearing loss associated with old age. However, many diabetics consult a specialist about the deterioration in their hearing, without mentioning that they are diabetic, so the link is not made.

 

How does diabetes cause hearing loss ? 

There are a number of ways the ears can be affected by diabetes, and hearing loss is frequently the result. Diabetics tend to have a lack of keratin protein which forms a protective layer within the year canal, enabling wax to travel outwards, and preventing over-stimulation of the ear canal tissue. Absence or abnormal level of keratin protein can lead to hearing problems.

Diabetes can also lead to hearing loss as it causes deterioration of the epithelial tissue in the ear canal. This can make the ear canal overly sensitive to the type of plastics commonly used in hearing aids, and can cause yeast, fungus, irritation and infection within the ear, particularly when the air circulation is limited by a hearing aid.

A third link between diabetes and hearing loss, is neuropathy or nerve damage, which is a common complication experienced by diabetics. High blood sugar levels associated with diabetes can cause chemical changes in the body’s nerves that can impair their ability to transmit signals. When this nerve damage occurs in the ear’s neurological system, people can experience problems hearing and understanding speech and also speaking themselves.

 

Is the link between diabetes and hearing loss limited to diabetes type 2 ?

As Type 2 diabetes and hearing loss have been linked in the past, it is usually associated with getting older. However, there is some research that now suggests children with Type 1 diabetes are also likely to experience hearing loss at an early age. The incidence and severity of hearing loss seems to be relative to how long they have had diabetes and how well their glucose levels are controlled.

 

Other symptoms of ‘old age’ can be due to diabetes

Recent research has been looking to see if there is a link between diabetes and hair loss. Again, many diabetics put their hair loss down to getting older, and don’t realise it may be linked to their condition. Hair loss can be caused by a number of factors including the stress on the body of coping with diabetes, and various diabetes related conditions including thyroid problems or PCOS.

Hair loss should reduce when glucose levels are well maintained. Often high blood pressure can be linked to diabetes, and hair loss can be caused by the medication used to treat this. Once the medication is changed or stopped, hair loss should reduce.

In the same way as diabetes and hearing loss, and diabetes and hair loss, deterioration of vision is often accredited to old age rather than diabetes. Diabetics can experience retinopathy which damages the vessels that supply blood to the retina. This can cause a gradual decline in vision.

Laser treatment is very effective in halting this gradual deterioration in vision, and is successful in 80% of cases, but early diagnosis is crucial. Diabetics should have regular eye tests, and get checked out as soon as they believe their sight to be deteriorating, rather than simply assuming it is a symptom of old age.

Courtesy: Sugar Diabetes

Rogue Protein 'May Spark Diabetes'

Shedding light on how a malfunctioning protein helps trigger type 2 diabetes could one day offer the chance to halt the damage, say scientists.The presence of amyloid protein may produce a chain reaction which destroys vital insulin-producing cells.

Researchers based in Dublin, writing in the journal Nature Immunology, say future drugs could target this process. Amyloid is implicated in many other diseases, most notably Alzheimer's. Type 2 is the most common form of diabetes, normally developing in later adulthood. It happens when the body both loses the ability to produce enough insulin to control blood sugar levels, and becomes resistant to the insulin that it does have.

Insulin is made in "beta cells" in the pancreas, and scientists first noticed "deposits" of the amyloid protein in pancreatic tissue of some people with type 2 diabetes some years ago. It was thought that amyloid could be poisoning the cells directly, but the latest research offers an additional explanation.

It found that a type of immune cell called a macrophage, whose normal role is to get rid of debris in the cell, reacted abnormally when it ingested amyloid. It triggered activity in other cells nicknamed "angry macrophages", which in turn released proteins that cause inflammation. The inflammation then destroys the vital beta cells, and the ability to produce insulin is reduced.

The researchers said that they hoped the finding would "spur new research" to target the mechanisms of the disease. Dr Eric Hewitt, a researcher into amyloid-related disease at Leeds University, said the paper was "interesting", and could help explain why the presence of amyloid deposits, or the process that laid them down, could be so damaging. He said: "It suggests we are looking at a very complex disease - we know that amyloid is present in some type 2 diabetics, but not others.

"What we have is a second indirect mechanism which can lead to the destruction of beta cells, and this could be helpful when looking at other diseases which may involve amyloid, such as Alzheimer's. "It does offer a possible opportunity to interrupt this mechanism at some point in the future and perhaps stop the disease from progressing."

BBC News

Research Findings May Lead To New Drugs For Diabetes

SCIENTISTS AT Trinity College Dublin have come up with a possible new way to treat the onset of type 2 diabetes. They identified a substance that helps to trigger damage associated with the disease, opening the possibility of new drug therapies.

Type 2 diabetes is a world health issue given its increasing incidence, largely driven by obesity, explained Prof Luke O’Neill, professor of biochemistry in Trinity College Dublin’s Immunology Research Centre.

It is “a big problem in Ireland”, Prof O’Neill said. “There is a huge need to come up with new treatments.”
Estimates suggest that up to 14 per cent of the Irish population over 40 have diabetes, and a tenth of the entire healthcare budget is spent treating diabetes and its complications, Prof O’Neill said.

More than 2,000 people die here every year as a result of diabetes-related diseases.

Diabetes occurs when the body cannot properly regulate sugar levels in the body. This in turn causes damage to a wide range of tissues over time if not controlled by giving the hormone insulin.

Symptoms include fatigue, blurred vision, slow wound healing particularly in the extremities and damage to organs. It also leaves diabetics with a higher risk of heart attacks.

Type 1 diabetes usually arises in childhood when the pancreatic cells that make insulin are destroyed by the body’s own immune system.

Type 2 usually arises later and in the main is a lifestyle disorder, in particular brought on by obesity.

Both types leave the body unable to regulate sugar levels, with type 2 controlled by insulin tablets and a careful diet. Both also are linked to an inappropriate immune response that sees our protective immune cells causing damage to the pancreas.

The researchers have opened the way for new treatments as a result of their discovery, details of which were published online yesterday by the leading journal, Nature Immunology.

“We have found what might be the straw that breaks the camel’s back in type 2 diabetes,” stated Dr Seth Masters, lead author of the publication.

It is all down to a substance known as Islet Amyloid Polypeptide (IAPP), Prof O’Neill said.

“We have come across a key protein in the body called IAPP. This irritates the immune system in the body,” Prof O’Neill said. “It is a breakthrough because nobody has come across this before.”

The effect of IAPP is to ramp up the immune response where it occurs in the pancreas.

DICK AHLSTROM/Irish Times

Diabetes Research: Drug Can Stop Debilitating Diabetic Neuropathy in Mice

A drug developed at the University of Kansas has the potential to stop a debilitating condition of diabetes that often leads to pain in the extremities and even amputations, KU researchers have found.

Lawrence, KS - infoZine - The researchers recently published an article showing that KU-32 can stop and even reverse diabetic peripheral neuropathy, or DPN, in mice. The condition leads to death of nerves in the extremities of individuals with diabetes.

“People with DPN can be very sensitive to light touch, which can cause significant pain,” said Rick Dobrowsky, professor of pharmacology and toxicology and one of the paper’s authors. “The other side is eventually diabetes causes death of the nerves. DPN often leads to loss of feeling in the hands and feet, which can make diabetics susceptible to wounds and infections and often leads to amputations of toes and feet.”

DPN is the second leading cause of amputations, after injuries.

Dobrowsky co-authored the paper with Brian Blagg, professor of medicinal chemistry; Roger Rajewski, professor of pharmaceutical chemistry; Joanna Krise and Michelle McIntosh, research associates with the Biotechnology Innovation and Optimization Center; Cuijuan Yu, research associate with the Higuchi Biosciences Center; postdoctoral researcher Yuanming Lu; and graduate students Michael Urban and Cuijuan Yu. It was published in the American Society of Neurochemistry’s journal, ASN Neuro.

The researchers administered KU-32 to diabetic mice. The compound stopped DPN and showed it could restore sensory neuron function to damaged nerve tissue. KU-32 inhibits a specific member of a family of proteins called molecular chaperones.

“These studies provide the first evidence that targeting molecular chaperones reverses the sensory hypoalgesia associated with DPN,” the authors wrote.

There are approximately 24 million diabetics in the United States. Dobrowsky said nearly 60 percent of them suffer from DPN at some point. The researchers hope that eventually the drug could be used to help to treat the condition in humans. Their research shows KU-32 can be administered orally as infrequently as once a week and still be effective. It has been shown to have long-term efficacy, meaning it could be administered in small doses, potentially reducing severity of side effects.

“Our tests so far indicate that KU-32 is completely nontoxic and is absorbed in the blood stream very well,” said Blagg. “It has long-term efficacy. It is a promising treatment.”

There are only two FDA-approved drugs used for treatment of DPN, Blagg said. However, one is an anticonvulsant and the other is an antidepressant, and neither has the potential to reverse nerve degeneration.

The research, funded by grants from the Juvenile Diabetes Research Foundation and the National Institutes of Health, is ongoing. The team is hoping to discover how long the drug can be effective in combating DPN. People often find out they have diabetes when they are suffering from the nerve-degenerating condition.

“The idea is to try to determine at what point in nerve degeneration will be most effective and at what point the drug will not be efficacious,” Dobrowsky said. “We’d like to know at what stage in the progression of DPN a window of opportunity exists for the beneficial use of KU-32.”

The researchers also hope to determine exactly how the drug stopped and reversed DPN in mice. It’s not immediately evident if it improved existing nerve fibers or generated new ones.

The drug is still in pre-clinical development. It will likely need another year or two of study, then the researchers hope it could be advanced to clinical trials in humans.

Dobrowsky said the collaboration of researchers with different areas of expertise was key to the study.

“This is an excellent example of how collaboration allows us to achieve one of the School of Pharmacy’s goals, to discover medications that enhance and extend life,” he said.

The article, “Inhibiting heat-shock 90 protein 90 reverses sensory hypoalgesia in diabetic mice,” is available on the ASN Neuro site @ http://www.asnneuro.org/an/002/an002e040.htm

Diabetes Drug Trials: Roche Halts Taspoglutide Dosing in Final Studies

Roche Holding has stopped giving patients its experimental diabetes treatment taspoglutide in late stage clinical trials due to a high rate of adverse reactions, marking a major blow to drug once seen to have $2 billion a year potential.

The Swiss drugmaker said on Friday that the decision was based on a higher-than-expected rate of discontinuations due to gastrointestinal (GI) intolerability, and due to serious hypersensitivity reactions experienced by some patients, according to 52-week data from the trials.

"These discontinuation rates compromise interpretation of the long term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients," Roche said in a statement.

Leerink Swann analyst Joshua Schimmer said in a research note that if Phase III dosing has been suspended "we believe that this is the final blow for what was perceived as a compound in trouble after the disappointing data on hypersensitivity and nausea/vomiting presented at the American Diabetes Association (meeting) this year."

The drug, given once weekly by injection, suffered a serious setback in June, when it was reported that there were cases of patients suffering hypersensitivity reactions to the medicine in clinical trials.

The latest blow to Roche is seen as a boon to Amylin Pharmaceuticals Inc  and Eli Lilly and Co, which are awaiting a US approval decision for their once-weekly injectable diabetes drug Bydureon.

Roche said it was not abandoning its drug, but was considering a reformulation of the medicine. Any reformulation would likely cause a significant delay beyond the one Roche signaled in June when the hypersensitivity data was revealed at the diabetes meeting.

At that time Roche said the setback would likely cause a delay in filing for approval of a minimum of 12 to 18 months. It had previously been aiming to apply for taspoglutide approval worldwide in 2011.

"Roche is assessing approaches to identify the root cause of the serious hypersensitivity reactions and to optimize the taspoglutide formulation to improve GI tolerability," Roche spokesman Terrence Hurley said.

"Upon review of options available, Roche will communicate about the next steps of the overall taspoglutide program by year end," he added.

Roche said out of 3,000 patients there were 23 cases of serious hypersensitivity reaction, and that all the patients recovered without complications.

While the percentage is low, as with the GI problems the number was higher than expected, Roche said.

The most frequently reported symptoms in patients who developed hypersensitivity reactions were skin reactions, nausea, and vomiting, while cardiovascular and respiratory symptoms were less frequent, Roche said.

Roche, which licensed taspoglutide from France-based Ipsen, once had high hopes for for the drug. It had said in the past that taspoglutide could garner peak sales of at least 2 billion Swiss francs ($1.77 billion).

However analysts had already sharply lowered their sales projections for the drug following the previous clinical setbacks.

"Amylin's Bydureon is expected to be the only weekly GLP-1 in the near-term," said ISI Group analyst Mark Schoenebaum in a research note, referring the class of drugs to which the Amylin/Lilly and Roche drugs belong.

Bill Berkrot/Reuters

Diabetes Research: Using Molecules to Stimulate Insulin Production

Researchers from the University of Pittsburgh have discovered that the stimulation of a single molecule can result in the increased production of insulin to help manage diabetes. The study was published in the journal Diabetes published by the American Diabetes Association.

The study also found many other combinations of molecules that stimulate beta cells to replicate. When beta cells replicate, insulin is produced and this helps in the control of the amount of blood glucose in the body. Diabetes is either the body’s inability to produce insulin or the low amounts of insulin produced for the body’s needs.

“Our team was the first to show that adult human beta cells can be induced to proliferate or grow at substantial rates, which no one thought possible before,” said senior author Andrew F. Stewart, M.D., professor of medicine and chief of the Division of Endocrinology and Metabolism, Pitt School of Medicine. “Now our effort has been to unravel these regulatory pathways to find the most effective strategy that will allow us to treat – and perhaps cure – diabetes by making new insulin-producing cells.”

The discovery was made when the team headed by Dr. Nathalie M. Fiaschi-Taesch found that the combination of elevated amounts of regulatory molecules cdk4 or cdk6 and D-cyclin proteins such as cyclin D3 results in the increased human beta cell production in test tubes. At the outset, there was no known role that cyclin D3 plays in human beta cell physiology but the discovery of its ability to increase replication overturned such notions.

When tested on rodent subjects, it was found that Cyclin D2 was essential in beta cell replication and functioning. On the other hand, the molecule was barely discernible in humans. The stimulation regimen, the study showed, can be sustained for at least four weeks in reengineered mice. These rodent subjects were transplanted with human beta cells that produce large quantities of cdk6.

This is but the start of another avenue in the treatment and management of diabetes. The use of regulatory proteins can be one of the best regimens yet available in increasing beta cell replication for diabetes worldwide.

From diabetesforum.com

Diabetes Discovery: Indian Scientists Create Novel Form Of Insulin

A team of Indian scientists has discovered a novel form of insulin that could drastically reduce the suffering diabetics face in controlling their blood sugar.

For the diabetics, daily painful pinpricks to inject doses of insulin is a routine affair, now in a new discovery scientists claim a single shot of insulin could help keep sugar levels under control for more than a month. Today the effect of each insulin injection lasts at best for a day.

India is considered the diabetes capital of the world, with as many as 50 million people suffering from this chronic disease, so any new discovery is welcomed with open arms.

The team spent less than $45,000 and took two years to come with this novel solution. These scientists have already patented the technology, commercialized it and the new insulin could well become a big money spinner in times to come, feels the man who discovered this new form of insulin.

"It is a multi-million dollar technology transfer agreement with royalties once the product goes to the market and if I am not wrong it is one of the biggest scientific innovations to have come from a government owned research laboratory," said Professor Avadhesha Surolia, Director, National Immunology Institute, New Delhi.

The researchers treated natural human insulin at varying temperatures and chemical conditions and one such special formulation does the magic. In experiments done on rats, mice and rabbits the team could control the sugar levels like of these diabetic rats simply by giving an injection once every three months.

Imagine having to do away with multiple injections everyday to control the sugar problem. The simplicity of the discovery and its huge potential has attracted immediate attention.

"Both conceptually and for clinical practice it is an exciting discovery because it uses natural chemically unchanged insulin and clinically it is useful because it provides ease for patients by reducing the number of pin pricks," said Dr Ambrish Mithal, Diabetologist and president, Endocrine Society of India.

It is not often that new drug is discovered in India, but its use in humans could still be many years away.

The new insulin molecule discovered by Indians in India could become a blockbuster drug in times to come as it holds a lot of promise, currently being tested on animals like on rats, it will soon undergo human trials and then it may become available as drug for the treatment of diabetes.

Reported by ndtv.com

Diabetes Management: Roche Diabetes Care and ICW Announce Technology Partnership

Roche Diabetes Care, a global leader in diabetes care and eHealth specialist InterComponentWare (ICW) have announced a multi-year, global partnership to develop a next-generation web-based solution for efficient diabetes management.

The structured evaluation and communication of blood glucose monitoring and insulin data is a pivotal part in efficient diabetes management. Until today, this poses a significant challenge for both people with diabetes and healthcare professionals. Developing a solution to ease the interaction between patients and healthcare providers will be the goal of the technology partnership Roche Diabetes Care and ICW have announced today.

Using the very successful Accu-Chek® 360° software and the powerful ICW eHealth Framework (eHF) as well as other solution components, Roche Diabetes Care and ICW will jointly develop a technology platform that will facilitate the secure sharing of data and communications between healthcare professionals and people with diabetes via the web and allow patients and caregivers to manage diabetes even more efficiently.

Already today, the Accu-Chek 360° software allows for well-structured visualization and assessment of important blood glucose and insulin data and enables healthcare professionals, as well as people with diabetes, to determine appropriate therapy.

Burkhard G. Piper, President Roche Diabetes Care, notes, "We conducted a comprehensive search for a technology partner and we were pleased to select ICW. It is our goal to continuously improve the information exchange between patients and their caregivers. We aim to provide new solutions that can facilitate the exchange of health data that are key for successful therapeutic interventions. 

Combining our knowledge and expertise, we will be able to leverage web-based technologies and make significant advances in the areas of connectivity between patients and healthcare professionals."

"The agreement with Roche Diabetes Care represents a culmination of our development efforts to date," explains Peter Kirschbauer, CEO of ICW AG. "Roche Diabetes Care will leverage the ICW eHealth Framework and our successful deployment of the highest security standards for information exchange, as we co-develop new and advanced approaches to sharing relevant diabetes data. We are very pleased to have Roche Diabetes Care as our partner." 

Almost Half 'Wrongly Believe Diabetes Can Be Triggered By A Sweet Tooth'

A survey found that many people think eating too much sugar can lead to the debilitating condition.

And a quarter object to diabetics injecting themselves with insulin in public, the charity Diabetes UK found. The group questioned more than 2,000 adults to uncover the myths that surround the condition.

It found that 42 per cent thought that diabetes could be caused by eating too many sweet foods. It warns that children are being bullied by other youngsters who believe that eating too much sugar caused their diabetes. Simon O’Neill, from the charity, said: “These sorts of myths are not helpful and can lead to discrimination and bullying.

“People with diabetes have a hard enough time living with their condition without being made to feel ashamed or different from their peers. Sadly, we often hear of children who are bullied at school because others believe they’ve brought their diabetes on themselves from eating too many sweets.”

Diabetes occurs when body struggles to regulate insulin.

Most children have type 1 diabetes, an auto-immune condition which is not affected by diet. Most adults suffer form type 2 diabetes, which can be affected by lifestyle choices, including obesity. However, it cannot directly be triggered by eating too much sugar.

Mr O’Neill added: “Diabetes UK is appalled that some people object to injecting in public. “For people who treat their diabetes with insulin, this is not a choice – insulin keeps them alive and injections have to be administered at specific times. “People should be able to inject in public without fear of being mocked or shunned by those around them.”

According to the WHO, by 366,000,000 people will be suffering from diabetes, up from the around 250,000,000 presently. The three countries with the highest prevalence are expected to remain China, India, and the United States -- as they are today. 

From The Telegraph/London

Diabetes: Novo Nordisk Takes Big Risk With Victoza

Novo Nordisk, with its US headquarters in Plainsboro, has become a pharmaceutical powerhouse in the battle against diabetes.

Novo Nordisk’s gamble on Victoza, its new drug for Type 2 diabetes, often looked like a long shot.

The company’s scientists spent nearly 10 years trying to develop a molecule that would act like a naturally occuring hormone called GLP-1. Once they did, there were still costly setbacks, puzzling questions and enormous doubts, none of which managed to thwart one researcher’s passionate belief in the hormone’s ability to be turned into a drug for lowering blood sugar.

In many ways, the determination that drove Victoza’s development demonstrates just how Novo Nordisk has become such a powerhouse in the battle against diabetes.

After nudging Eli Lilly out as the dominant player in the U.S. diabetes market nearly a decade ago, Novo Nordisk has seen its sales soar. Of course, that’s due in no small part to the nation’s troubling epidemic of diabetes, which creates a huge market for new medicines such as Victoza.

And as the disease grows more prevalent and more costly, the Danish health-care giant, which employs about 1,000 people at its US headquarters in Plainsboro, finds itself trying to balance its search for new treatments with an even more daunting quest: finding a cure.

"They’ve come a long way,’’ Donny Wong, an analyst who follows diabetes drugmakers for Decision Resources. "They’ve been growing rapidly." When Novo Nordisk entered the US market, Eli Lilly’s insulin sales volume outpaced its new competitor 2-to-1. Today, Novo Nordisk controls 42 percent of the total US insulin market, with products such as NovoLog and Levemir.

Lars Rebien Sorensen, chief executive officer of Novo Nordisk, said the company’s insulin business in the US remained small for years, but has grown steadily. Its sales force has ballooned from 165 in the late 1990s to about 1,900 today.

"The last eight years or so have been extraordinary,’’ Sorensen said during a recent interview in New York City. "If you look at our growth, two-thirds of it comes from the U.S.’’

To understand the significance of the US to the company, just look at the prospects for Victoza, which was approved by federal drug regulators earlier this year. Nearly 70 percent of the drug’s value is projected to come from the US, according to Sorensen.

BUILDING A PRESENCE

Novo Nordisk was formed in 1989 when two 76-year-old Danish insulin makers merged. From the start, the company focused on diabetes.

While Novo Nordisk, which generated $9.5 billion in sales last year, remains focused on making insulin, it also makes money on treatments for hemophilia and hormone-replacement therapies. In fact, the hemophilia treatment NovoSeven provided Novo Nordisk with the commercial tail wind it needed to begin building its presence in this country.

With an estimated 24 million Americans diagnosed with diabetes — and many millions more around the world — the market for drug companies is huge and growing. Decision Resources, a research firm that follows the health-care industry, expects the global market for Type 2 diabetes to reach nearly $35 billion, up from $17.5 billion in 2008.

While Novo Nordisk wrestled market share away from Eli Lilly and steadily grew its insulin business in the US, other drugmakers were developing treatments to help address the surge in Type 2 diabetes.

Amylin Pharmaceuticals was one of them. The San Diego-based drugmaker, which partnered with Eli Lilly, beat Novo Nordisk to market with Byetta, the first drug in the GLP-1 class.

GLP-1 is short for glucagon-like peptide 1, a naturally occuring compound that works on different organs to lower the levels of blood sugar. For overweight diabetics, there’s another benefit: GLP-1 attaches to a receptor in the brain to decrease appetite, which over time, leads to weight loss. 

Wong said although insulin is used to treat both types of diabetes, Novo Nordisk has few other targeted therapies for Type 2. "It is a relative newcomer to that space,’’ he said.

Novo Nordisk jumped into the race early on, according to Sorensen, but its progress getting to the finish line was slow and hampered by the sort of issues that characterize all drug development.

"It took us some time, I have to admit,’’ Sorensen said.

'MRS. LIRAGLUTIDE'

Lotte Bjerre Knudsen, a senior scientist at Novo Nordisk, led the 20-year effort to develop Victoza. Before the drug received its brand name, it was known by its scientific name, liraglutide. And in the research laboratory, Knudsen’s dedication earned her the nickname "Mrs. Liraglutide.’’

"There were doubts about whether this would ever be a drug,’’ Knudsen said in an interview last week from Buenos Aires, where she was vacationing. "When you’re making something completely novel, it’s not so untypical."

The promise of the GLP-1 class of drugs fueled the company’s efforts through major setbacks, including a flawed dosing study that cost researchers 18 months. With each setback, Knudsen had to defend the project to management.

Knudsen said her team postponed celebrating Victoza’s development until the drug was approved by U.S. regulators. "It wasn’t good enough until we received that," she said.

Sorensen isn’t ruffled by the criticism that his company took too long to get Victoza to market. "This would typically be our philsophy, to ensure that we have the most optimal molecule,’’ he said. "It has occasionally led to us being second to the market.’’

But being second does have disadvantages. Wong, the analyst with Decision Resources, said Novo Nordisk already has a new competitor nipping at its heels.

Wong said analysts at Decision Resources are contemplating lowering projections that suggested Victoza would generate about $500 million a year by 2019. The company has predicted Victoza will be a blockbuster — a name typically given to a drug that generates $1 billion in annual sales — within five years.

Wong said Victoza’s challenge will come later this year when Amylin and Eli Lilly are expected to launch Bydureon. The new drug offers patients a more convenient medicine they have to inject once a week compared with three times a day or Victoza’s once-a-day regimen.

The ability of Novo Nordisk to capture market share depends on how rapidly it can persuade diabetics to try its once-daily formulation before Amylin’s Bydureon comes on the market.

"The problem is Novo Nordisk has a very narrow window of opportunity," Wong said.

WORKING ON A CURE

In the business world, it seems counterintuitive for a company to diligently work on something that has the potential to put it out of business. Yet, at Novo Nordisk, scientists have spent the past decade doing stem cell research in hopes of discovering a cure for diabetes.

"We have a deep commitment to this, but there’s also a realization that it’s a tough nut to crack,’’ said Alan Moses, chief medical officer at Novo Nordisk. "It’s getting closer to reality.’’

But David Kendall, chief scientific and medical officer for the American Diabetes Association, said researchers have had high hopes of finding a cure for diabetes for decades. In addition to stem cell research, scientists are studying other possibilities, including the development of an artificial pancreas.

"We’re talking about years of development that are still necessary,’’ he said. "Is it three to five or is it 20, it’s difficult to say.’’

Susan Todd/The Star-Ledger

Advinus Sees Diabetes Molecule Breakthrough In Six Months

The Tata Group-promoted Advinus Therapeutics is expecting a breakthrough for a diabetes molecule in about six months. The company is likely to license it to other companies, according to Tata Sons Executive Director R Gopalakrishnan.
Advinus has already completed the first-stage development of the molecule and is set to initiate talks with pharma companies for further drug trials, he added. At present, five full-discovery programmes are on for internal research.

Advinus has a collaboration with Merck (USA) for drug discovery in the area of metabolic diseases.

The company has a drug discovery centre in Pune that focuses on diabetes, obesity, lipid disorders, inflammatory diseases and neglected diseases like dengue and malaria. Its Bangalore centre has a collaboration with DNDi (Drugs for Neglected), he said.

60 Diabetes Seconds May Prevent A Diabetes Life

Given the statistics, no matter where you live, no matter your age or race, fat or thin, you may get diabetes. Did you know type 2 diabetes is the fifth leading cause of death in America and its complications affect every bodily system?

Most people don't know. That's why the International Diabetes Federation (IDF) has launched a series of great-to-look-at, real-people-on-the-street videos.

They're meant to wake you up - they woke me up to how little people know about diabetes - and shake you out of your slumber. Because if you don't know much about type 2 diabetes - the diabetes that's largely preventable - you're sleeping. 

And, trust me, you want to wake up and start taking steps so you don't get it.

I first saw these videos on DiabetesMine, the award-winning diabetes blog of advocate Amy Tenderich. Frankly you need to see them too. I suspect one of these is going to be the one that wakes you up to get tested for diabetes.

First, the shocking statistic most people don't know.

Q: How many people on the planet have diabetes?

Twenty-four million Americans have diabetes. 6 million of them don't know it.

Sixty million people are in line for type 2 diabetes - they have pre-diabetes. Think, there's a reason why they call it that.

One in three Americans will get diabetes in their lifetime. Nearly 1 in 3 children are either overweight or obese. Our future type 2 diabetics, many of whom will get diabetes before they ever leave childhood. That also means they'll have heart disease, high blood pressure, potential blindness, kidney disease and amputations in the prime of their lives.

Q: Which country has the most people with diabetes?

China - 92.4 million. With more than 1,000 McDonalds and 2,000 Kentucky Fried Chickens on street corners.

By 2025 the US, China and India will have the largest populations with diabetes. Researchers at the University of Chicago estimate that in a little more than 20 years the total number of Americans with diabetes will almost double, rising to over 44 million. That's almost 1/7 of the current American population. The World Health Organization projects diabetes deaths will double between now and 2030, and the IDF estimates by 2030 half a billion people around the world will have diabetes.

Q: What do most people with type 2 diabetes die of?

Heart disease, strokes and heart attack. By time you're diagnosed with type 2 diabetes, chances are high you have all the major cardiovascular risk factors.

But first, you can lose body parts.

If you don't have diabetes, keep it that way. Take the American Diabetes Association's risk test. If you're at risk, tell your doctor. It's your life - while you've got it.

Q: More people have diabetes than what two illnesses combined?

Breast cancer and AIDS. Imagine that!

So, how come we don't have a ribbon? 

Maybe it's just the music, but that chokes me up every time. If you have diabetes join the millions this November who'll be spreading the word about diabetes prevention and education. If you have pre-diabetes and are overweight and aren't taking steps right now to shed some pounds and get active, please feel free to join us on World Diabetes Day - you'll be there soon enough.

One last look at diabetes from Novo Nordisk, Diabetes Month 2008. Funny, how little has changed. 

One last question: What country sponsored the 2006 United Nations resolution for World Diabetes Day?

Bangladesh. After the U.S. and most countries in Europe declined.

You don't have to be a superpower to change the world. You don't have to be a superman or woman to stop diabetes now for yourself, your family or your loved ones.

The International Diabetes Federation is an organization of over 200 national diabetes associations in over 160 countries. IDF has been leading the global diabetes community since 1950. IDF's mission is to promote diabetes care, prevention and a cure worldwide. With the incidence of diabetes around the world rising so quickly, for the first time in their 58-year history, the IDF will begin meeting every two years instead of every three.

Thank you Riva Greenberg 

Some Health Factors May Be Linked To Cognitive Problems For People With Type 2 Diabetes

Type 2 diabetes is linked with a number of health problems, but a new study finds that older diabetics who have high blood pressure, gait and balance problems or think their health is poor may be at higher risk for cognitive problems.

Researchers looked at 13 potential variables that could affect cognition, including grip strength, blood pressure, involvement in physical activities, social engagement, gait and balance, and a subjective measure of a person's health.

The study participants, from British Columbia, included 41 people with Type 2 diabetes age 55 to 81, and a matched group of 458 healthy people that served as a control. They were given cognitive tests that measured memory, verbal fluency, neurocognitive speed, and other abilities.

Three health-related variables were found to be most associated with a higher risk of cognition problems: high systolic blood pressure (the top number that measures the heart's contractions), walking more slowly and being unstable, and thinking that one's health is bad.

Blood pressure might be a factor, the study authors said, because of its role in other metabolic issues such as insulin resistance and hyperglycemia, which may be risk factors for cerebrovascular impairment. Walking and balance could figure in since diabetes may influence the areas of the brain that control gait, balance and cognition. And because Type 2 diabetes can affect stress and depression, those factors could influence results on cognitive tests.

Though the study points out that these related health issues may not always produce learning or memory problems, they are important enough risk factors to be noted.

"Awareness of the link between diabetes and cognition could help people realize how important it is to manage this disease; and to motivate them to do so," said study co-author Roger Dixon of the University of Alberta, in a news release.

The study appears in the September issue of the journal Neuropsychology.

Thank you Jeannine Stein/Los Angeles Times