New Drug May Someday Battle Obesity and Diabetes – WebMD

New Drug May Someday Battle Obesity and Diabetes

Researchers find slim evidence to support many

By Dennis Thompson

HealthDay Reporter

WEDNESDAY, Oct. 30 (HealthDay News) — A new diabetes drug may one day perform double duty for patients, controlling both their blood sugar levels and helping them lose weight, researchers report.

In mouse trials, doctors found the drug prompted weight loss, in addition to managing blood sugar levels.

“That [weight loss] is not what this drug was designed to do, but it’s a very attractive additional benefit,” said study co-author Richard DiMarchi, a research chemist at Indiana University in whose lab the drug was created.

The injectable medication is based on a single molecule that combines the properties of two hormones that send chemical signals to the pancreas, said DiMarchi.

“They signal to the pancreas that you are taking a meal,” DiMarchi said. “The pancreas then responds by secreting insulin and to synthesize additional amounts of insulin for subsequent use.”

People with type 2 diabetes have lower levels of these pancreas-signaling hormones, which are known as incretins, explained Dr. John Anderson, president of medicine and science at the American Diabetes Association.

“The incretin defect in type 2 diabetes is well known, and it’s only within the last few years we have had agents to treat it,” Anderson said.

Human and primate trials revealed that the new drug controls blood sugar with fewer side effects than other diabetes medications. Those side effects can include nausea, vomiting and stomach pain.

“In this study, the degree of gastrointestinal discomfort is much more modest than is experienced in conventional drugs,” DiMarchi said. “We get beneficial glycemic control with this combination drug, and it seems to be with less adverse drug effect.”

The medication combines the action of the hormones GLP-1 and GIP. Current diabetes medications of this sort target GLP-1 receptors in the body; studies involving GIP have produced mixed results.

GLP is known to suppress appetite, and DiMarchi said the weight loss observed in mice might be occurring because the second hormone, GIP, is somehow “turbo-charging” that appetite suppression.

In the mouse trials, a drug based on GLP-1 alone decreased body weight by an average 15 percent. But the new drug combining GLP-1 and GIP decreased body weight by nearly 21 percent, as well as controlling blood glucose and decreasing appetite.

A six-week human trial involving 53 patients with type 2 diabetes found that the medication effectively controlled their blood sugar levels. However, the researchers did not note any change in weight during the relatively short study period.

The higher potency of the combined molecule suggests it could be administered at lower doses than other incretin-based medications, reducing side effects and making the drug easier to take.

“Currently approved drugs are quite effective,” DiMarchi said, “but they are insufficient in normalizing glucose, and they certainly don’t cause much loss of body weight.”

A diabetes drug which does not hurt your heart

BARCELONA: Mankind’s fight with diabetes and its associated medical complications goes back over 3,500 years ago. In fact, the earliest record of diabetes, written on a third dynasty Egyptian papyrus by physician Hesy-Ra , describes it as a “great emptying of the urine” .

Medical advances since then have progressed from treating diabetes with “wheat grains, fruit and sweet bee” to a host of integrated drugs, apart from a regimen of diet and exercise.

Currently, diabetes (both Type 1 and 2) affects an estimated 371 million people and kills over 4 million annually worldwide. Worryingly, over 63 million of these patients are found to be in India alone. Even more alarming is the correlation between diabetes and cardiovascular (CV) disease. Studies have shown that approximately 50% of diabetics die of a cardiovascular event.

As Dr Mark Kearney, professor of cardiovascular and diabetes research at the British Heart Foundation, University of Leeds, said: “If you are a South Asian, you are not only more susceptible to Type 2 diabetes but also to cardiac failure.” In fact, the cardiovascular age of a diabetic is pegged at 15 years more than the patient’s biological age. In simple terms, people with diabetes are four times more likely to die of a heart attack or stroke as compared to those who don’t have diabetes.

The main outlook in treatment of such patients is not to increase the risk of CV events even further. This is where data from Phase 3 trials in linagliptin, a DPP-4 inhibitor, holds out some sweet news. Boehringer Ingelheim and Eli Lilly and Company recently announced at the annual European Association for the Study of Diabetes meeting that treatment with linagliptin is not associated with increased risk of CV events in the treatment of T2D. Linagliptin (a 5mg tablet, once daily), is the only DPP-4 inhibitor that does not require dose adjustments in adults with T2D.

It is marketed as Trajenta in Europe and Tradjenta in the US. The results from the Phase 3 clinical trials of linagliptin, that covered 6,000 people with T2D in various countries, are even more heartwarming when its efficacy, safety and tolerability levels, especially among elderly patients, are considered.

(This correspondent was in Barcelona at the invitation of Boehringer-Ingelheim )

Big Pharma eyes more revenue with potentially dangerous new …




(NaturalNews) As obesity weighs down over a third of the United States adult population, drug companies are moving in to save the day. Arena pharmaceuticals, along with the FDA’s nod of approval, are set to begin marketing the first FDA approved weight loss drug in 13 years. The drug, lorcaserin, will be marketed in the US as Belviq, a pill designed for those with chronic weight issues with a BMI of 30 or more. It will also be prescribed to those with a BMI of 27 with at least one “weight related” condition such as high blood pressure, type 2 diabetes, or high cholesterol. With projections of obesity to strike half the US population in the next 10 years, this ‘quick fix’ pop-a-pill mindset will do nothing but perpetuate the problem and ignore the root causes.

The U.S. Drug Enforcement Agency has declared lorcaserin a Schedule IV drug, according to the Controlled Substances Act, which now states that this drug has the potential for abuse and dependence.

Abuse and dependence is definitely not the positive and correct way to deal with a problem like obesity, but the pill is poised to be just that – another pharmaceutical dependency program, aimed at taking advantage of the growing obesity market in the United States. According to the DEA, this anti-obesity drug now falls into the categories of drugs like the anti-anxiety benzodiazepines and the sleep aid Ambien, which have become abused and depended upon in recent years.

The DEA’s concern lies in lorcaserin’s potential to cause mind altering effects.

The researchers found out that some patients who received higher than recommended doses of lorcaserin in clinical trials reported “altered perception, abnormal dreams, sedation, or feelings of euphoria.”

With a wide, ever-growing obesity market, lorcaserin could become a cheap street drug that adolescents might abuse as they look for a cheap recreational high. Pharmaceutical abuse and misuse is growing trend with adolescents, especially with stimulants Ritalin and Adderall.

The mind altering effects of Belviq come from the drug’s stimulation of brain receptors. Lorcaserin works in much of the same way as LSD, stimulating the 5-HT2A receptor. (In a Canadian study, a 60 mg dose was deemed similar to an LSD trip). Lorcaserin also stimulates the 5-HT2B receptor, which is associated with heart valve disease (just another side effect to go along with this ‘miracle drug’). Finally Lorcaserin stimulates the third receptor 5-HT2C, which effects appetite.

Many people try to lose weight by going on the latest fad diet, popping a pill, or going with a quick fix. The fads may work for a little while, but the changes are only temporary as weight always finds a way to work its way back in. The key to losing weight and keeping healthy organs is to adopt a long term health strategy rooted in lifestyle changes. This includes eliminating bad habits one at a time, learning how to limit oneself and say no. It’s what one does most of the time that matters.

Incorporating new habits will have a more lasting impact, such as weekly detoxification of the cells, regular fruit and vegetable juicing, and cutting out toxins like processed genetically modified food, BPA lined bottles and cans, fast food, artificial sweeteners, processed sugars, corn syrup, nitrates and bleached flour. Taste buds will change. The craving for salty fries will melt away to an addiction for fresh orange and carrot juice. Spinach and kale salads will replace a processed macaroni dinner. The sight of McDonald’s will nauseate and farmer’s markets will become a safe haven.

There is a way out, there is hope for an obese population. It starts in the mind. Do you want to change? It does not include sitting back, popping a pill, and expecting something great to happen. There’s got to be more initiative than that. There’s got to be an ambition to be all that one can be, and it’s got to come deep from within.

Sources for this article include:

http://theweek.com

http://www.dailymail.co.uk

http://www.forbes.com

http://www.cdc.gov/obesity/data/adult.html

http://www.bioworld.com

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Big Pharma eyes more revenue with potentially dangerous new obesity pill

Diabetes drug: Ban lifted after talks with experts

After the health ministry consulted the Drug Testing Advisory Board and experts in diabetes, the ban on Pioglitazone drug was lifted.

The ministry concluded that, if used appropriately in the right type of patients, the drug is effective and safe for treatment of Type 2 diabetes.

Welcoming the lifting of the ban, Dr KP Singh of Fortis Hospital said Pioglitazone was safe and the decision to ban the drug was taken in haste by the central government.

Dr Singh said, “There are over 6 crore diabetes patients in India. Over 30 lakh of these take Pioglitazone due tot its favourable action.”

He added that about 95 per cent of patients suffer from Type 2 diabetes, in which the patient becomes insulin resistant.

Pioglitazone is the most commonly used drug for treatment of this disorder.

“Pioglitazone remains among the most effective and economical Type 2 diabetic drugs in the market and patients should consult their doctors for queries. In general, doctors prescribe the drug only after knowing the patient’s history and eligibility of the drug for the particular patient,” Dr Singh added.

The drug improves blood sugar levels in people with Type 2 diabetes by increasing the patient’s reactivity to insulin, which makes it an important prescription choice for doctors.

It is an economical alternative to insulin and is also cost-effective.

Talking about the precautions while taking the drug, Dr Singh said, “The drug should not be used as a first choice. Doctors should check the status after three to six months. The drug should not be prescribed to those suffering from cardiac or renal failure. It should not be given to those who have active or a history of urinary bladder cancer or Haematuria (blood in urine).”

When asked if any incidence of cancer had been reported in north India because of Pioglitazone he said not a single case had been reported. The drug is commonly available in market as Pioglit, Pionorm and Pioglar.


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Type 1 Diabetes Drug Proves Effective in Clinical Trial

An experimental drug designed to block the advance of type 1 diabetes in its earliest stages has proven strikingly effective over two years in about half of the patients who participated in the phase 2 clinical trial.

Jeffrey Bluestone, PhD

Patients who benefited most were those who still had relatively good control of their blood sugar levels and only a moderate need for insulin injections when the trial began. With the experimental drug, teplizumab, they were able to maintain their level of insulin production for the full two years – longer than with most other drugs tested against the disease.

Results are published online in the journal Diabetes, and will appear in the November issue of the print edition.

The treatment did not benefit all patients. Some lost half or more of their ability to produce insulin – a drop similar to many of the controls not receiving the drug. Reasons for the different responses are unclear, but likely involve differences in the metabolic condition of the patients and in the severity of their disease at the trial’s start, the researchers said.

Kevan Herold, MD, PhD

“The benefits of treatment among the patients who still had moderately healthy insulin production suggests that the sooner we can detect the pre-diabetes condition and get this kind of drug onboard, the more people we can protect from the progressive damage caused by an autoimmune attack,” said Jeffrey Bluestone, PhD, co-leader of the research and A.W. and Mary Clausen Distinguished Professor at UC San Francisco, who collaborated in developing the drug. 

The clinical trial was led by Kevan Herold, MD, PhD, a professor of immunobiology and deputy director for translational science at Yale University. He and Bluestone have collaborated on four previous clinical trials of the experimental drug.

“We are very excited by the efficacy of the drug,” Herold said. “Some of our patients and families have described a real impact on their diabetes.”

Bluestone, an immunologist who is now executive vice chancellor and provost at UCSF, developed teplizumab in collaboration with Ortho Pharmaceuticals in 1987. He is a leader in research that aims to understand how and why the immune system attacks the body’s own tissues and organs, and to develop drug strategies to eliminate the autoimmune response without producing severe side effects.

Catching Diabetes in Earliest Stages

The results underscore the importance of diagnosing and treating diabetes in its earliest stages, the researchers said. Current treatment studies include “pre-diabetes” patients who have abnormal blood sugar levels but do not need to take insulin.

Formerly referred to as juvenile diabetes because it disproportionately strikes children, type 1 diabetes is caused by an autoimmune condition in which the body’s immune system destroys insulin-producing beta cells in the pancreas. Even with insulin treatments, the blood glucose levels fluctuate abnormally, and as the disease progresses, diabetes increases the risk of kidney failure, heart disease and other serious disorders.

According to JDRF, as many as 3 million American have type 1 diabetes, and each year, more than 15,000 children and 15,000 adults are diagnosed with the disease in the United States. For reasons still unknown, the incidence of type 1 diabetes is increasing, and the age of onset is decreasing.

Controlling Autoimmune Reactions

Teplizumab is one of a number drugs under active investigation to control autoimmune reactions. Teplizumab uses an antibody targeted against a molecule called CD3 to bind to the immune system’s T-cells and restrain them from attacking beta cells.

Immunotherapies are designed to treat organ transplant rejection and autoimmune diseases, including multiple sclerosis, Crohn’s disease, rheumatoid arthritis and asthma. The use of these agents in type 1 diabetes is emerging based on work in preclinical models and clinical trials.

The journal’s print edition will include a commentary by Jay S. Skyler, MD, chairman of the National Institutes of Health-funded Type 1 Diabetes Trial Net, an international network of researchers that also studies teplizumab for prevention of type 1 diabetes. Skyler writes that the new results make a compelling case for U.S. Food and Drug Administration approval to launch a much larger-scale, phase 3 clinical trial of the drug’s effectiveness.

The study focused on 52 participants, most of whom were less than 14 years old, who had been diagnosed with “new-onset type 1 diabetes” within eight weeks of the trial’s start. All 52 were treated with the experimental drug for two weeks at diagnosis and again one year later, and their capacity to produce their own insulin to control their blood sugar was compared with a non-treated group.

Because the participants received daily insulin injections before and throughout the trial, researchers instead monitored their blood levels of C-peptide, a molecule produced in the pancreas at the same rate as insulin.

Watch this video to learn more about the groundbreaking work of the UCSF

Diabetes Center.

This research was a project of the Immune Tolerance Network (NIH contract #NO1 AI15416), an international clinical research consortium supported by the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Research Foundation. It also was supported by NIH grants UL1 RR024131 and UL1 RR024139.

Co-authors on the paper and collaborators in the clinical trial with Herold and Bluestone include Stephen E. Gitelman, MD, UCSF; Mario R. Ehlers, PhD, and Peter H. Sayre, MD, of the Immune Tolerance Network (ITN), San Francisco; Peter A. Gottlieb, MD, University of Colorado;  Carla J. Greenbaum, MD, Benaroya Research Institute, Seattle; William Hagopian, MD, Pacific Northwest Diabetes Research Institute, Seattle; Karen D. Boyle, MS, and  Lynette Keyes-Elstein, DrPh, Rho Federal Systems Division, Chapel Hill; Sudeepta  Aggarawal, PhD, and Deborah Phippard, PhD, ITN, Bethesda; James McNamara, MD, National Institutes of Allergy and Infectious Diseases.

Conflict of interest statement: Jeffrey Bluestone has a patent on the teplizumab molecule. Kevan Herold has received grant support from MacroGenics, Inc., a company that owns rights to the drug.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

Diabetes drug back with warning, but will patients swallow the pill?

Govt directive warns that Pioglitazone should not be first line of therapy

Diabetes drug pioglitazone and its combinations are back, but with a box warning in “bold red letters” to caution patients.

For a drug suspended a month ago for its possible links to urinary bladder cancer, its revocation could end up being a tough pill to swallow, especially for new patients with type II diabetes, say doctors.

Patients who have controlled diabetes with pioglitazone may still go back to the drug, says diabetologist Rajiv Kovil.

But putting new patients on pioglitazone may fall by at least two-thirds, he says, as they would be “extremely anxious”.

An engineer by profession, 43-year-old Rishi Kumar, for instance, would not like to take the medicine, now that he has doubts about its safety. He would, in fact, go for a second opinion if he is prescribed the medicine again.

Warnings

Pioglitazone is used as a third line of treatment. In its latest directive, the Government has emphasised the need for caution, insisting that the drug not be used as the first line of therapy, says Kovil.

The Government has brought back pioglitazone with several riders. Doctors need to run tests on the patient before initiating treatment, restrict use of the drug in elderly patients and prescribe it only after knowing the patient’s history.

It also requires patients on pioglitazone to be put through 3-6 monthly reviews.

Diabetologist V. Mohan is happy that, after much discussion, the Government has laid down several conditions on the use of pioglitazone. He was also involved in the discussions on pioglitazone and its suspension.

Patients will go by what the doctor says, and the doctor needs to share all these risks with the patient before starting the drug, he points out.

Precisely the sentiment of 69-year-old A.N. Dutta, suffering from type-2 diabetes for 10 years.

“I would not like to second-guess my doctor on this issue. Ultimately, it is about having faith in your doctor’s judgment. Now that the ban has been revoked, if he prescribes the medicine (piloglitazone) again, I will take it,” he says.

jyothi.datta@thehindu.co.in

aesha.datta@thehindu.co.in

Merck's $5.7 Billion Diabetes Franchise Vulnerable

A retrospective analysis published by the BMJ supports previously published findings that diabetic patients taking drugs which target the incretin system to control their blood sugars are at greater risk for developing pancreatic problems, such as acute pancreatitis and pancreatic cancer. Could certain big pharma manufacturers be vulnerable to a price collapse, should European and U.S. regulators – whom are now actively reviewing data on adverse events – move to restrict usage or outright remove these therapies from the market due to questionable safety?

MRK Total Return Price Chart

MRK Total Return Price data by YCharts

Incretin-based therapies, such as GLP-1 agonists and dipeptidylpeptidase-4 (DDP-4) inhibitors, mimic the glucose regulating role of intestinal hormones. As they carry a lower risk of hypoglycemia and have observed weight-loss properties, the two drug classes have readily been adopted by physicians for treating type-2 diabetes, with several drugs rapidly growing annual sales in the estimated $40 billion market for diabetes control medications.

MRK Revenue Annual Chart

MRK Revenue Annual data by YCharts

As Merck (MRK) looks to reset its revenue base due to patent losses, its DDP-4 inhibitor, Januvia (sitagliptin), remains critical to its financial health. In FY 2012, global sales of the combined diabetes franchise of Januvia/Janumet (which contains the popular type-2 diabetes drug metformin) grew 23% to $5.7 billion, primarily driven by growth in the United States and Japan. A global ban would wipe out more than 12% of the drug maker’s annual sales!

Though Novartis’ (NVS) DDP-V inhibitor Galvus delivered 34% growth in 2012, its $910 million in sales accounted for less than 2% of the $57 billion in annual drug sales. The Swiss-based company’s growth engines are fueled by oncology and neuroscience drugs, such as Gleevec and Gilenya (multiple sclerosis).

The consumer advocacy group Public Citizen has petitioned the FDA to remove Novo Nordisk’s (NVO) Victoza (liraglutide). Albeit the Danish-based drug maker derives almost 10% of annual sales from this GLP-1 agonist, the current safety debate could actually benefit the company: Insulin products generated almost 60% of the $11.7 billion in drug revenue last year; and, with a global insulin market share of more than 47%, any move back to mainstream diabetic treatment would likely more than offset lost sales from Victoza.

In addition to lost sales, all drug makers of incretin mimetics, including the newer DPP-4 inhibitors – Tradjenta (linagliptin) from Eli Lilly (LLY) and Nesina (alogliptin) from Takeda – will need to put aside reserves due to the possibility of multi-million dollar injury settlements (class action lawsuits are being filed).

David J. Phillips, a contributing editor at YCharts, is a former equity analyst. His journalism has appeared in Bloomberg BusinessWeek, Forbes, and Kiplinger’s Personal Finance. From 2008 to 2011, David was a reporter for CBS News Interactive. He can be reached at editor@ycharts.com. You can also request a demonstration of YCharts Platinum.

Drugs board wants ban on diabetes drug revoked

The Drugs Technical Advisory Board (DTAB) on Friday recommended revoking the ban on pioglitazone — an oral anti-diabetic drug which was banned on June 18.

But the DTAB, which was kept in the dark when the decision to ban was taken, has also recommended that the medicine be sold with a boxed warning (that the drug carries a significant risk of serious or even life-threatening adverse effects).

The recommendations have been sent to the Union Health and Family Welfare Ministry, which will issue the formal orders.

The Ministry banned piogiltazone based on a letter sent in January to the Drug Control General of India (DCGI) by Chennai-based diabetologist Dr. V. Mohan, chairman of Dr. Mohan’s Diabetes Specialities Centre. His letter was based on his observation of eight bladder cancer cases in patients, taking the drug. His data was published only as a ‘letter-to-the-editor’ in the Journal of Association of Physicians of India (JAPI) and hence was never peer reviewed prior to publication.

The expert committee meeting convened on July 11 wanted the ban revoked. The committee was formed when the government was severely criticised by diabetologists for acting in haste and without any study on the matter. India approved pioglitazone more than a decade ago and many thousands are on this drug.

As per records available on the website of the Clinical Trials Registry – India (CTRI), Dr. Mohan’s Centre is one of the participating institutions in five human clinical trials involving MSD’s anti-diabetes Sitaglipitin drug. MSD is the Indian subsidiary of Merck. His Centre is not a part of the sixth trial being conducted in India by MSD. But the company is funding a certificate course run by Dr. Mohan’s Diabetes Education Academy for the last two years.

“There is no conflict of interest at all… [Being a part of the trial has] absolutely not influenced me,” Dr. Mohan told The Hindu. “As a WHO Collaborating Centre for Non-Communicable Diseases, it is our duty to inform the health authorities about possible side effects of drugs.”

“The very fact that the government has placed so many restrictions on its use today shows that the drug does indeed have serious side effects,” he added.