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Archive for the ‘Research and Development’ Category

Experimental Therapy Reverses Type 1 Diabetes in Mice

Wednesday, August 1st, 2007

Researchers have accomplished what might be a cure of type 1 diabetes — at least in mice — and they’re taking the first steps toward a human trial.Type 1 diabetes is the autoimmune form of the disease, affecting about five percent of diabetics. It usually emerges in childhood and occurs when the body’s immune system attacks insulin-producing beta cells in the pancreas.

Now, a three-drug regimen that not only stops the destruction of beta cells but also preserves the function of cells that receive and metabolize insulin has eliminated type 1 diabetes in laboratory mice, said lead researcher Maria Koulmanda, director of nonhuman primate research at the Transplant Research Center, Beth Israel Deaconess Medical Center in Boston.

Her team published its report July 30 in this week’s online edition of the Proceedings of the National Academy of Sciences.

“We stopped the progression of automimmunity. The animals could become normoglycemic,” meaning they had normal levels of blood sugar, Koulmanda said.

Another major discovery is that inflammation appears to play a major role in type 1 diabetes, she added. In fact, one drug used in the treatment regimen reduced the inflammation of cells that metabolize insulin.

“Basically, by blocking inflammation, we were getting the animals to be insulin-sensitive,” Koulmanda said.

Another drug successfully reduced the autoimmune destruction of beta cells, but that was not the key to reversing the disease, she said. Instead, success was linked to blocking inflammatory processes that impair cells’ responses to insulin.

Some of the cells involved in insulin metabolism were found to be resistant to insulin’s effects — a common phenomenon seen in much more common, adult-onset, obesity-linked type 2 diabetes, Koulmanda said. “This is the first time anyone has seen insulin-resistant cells in type 1 diabetes,” she noted.

A course of treatment lasting less than four weeks restored normal blood sugar function in the test mice. In contrast, mice that did not get the treatment died during that month-long period.

Based on these promising results, the first work need to s?art a human trial of the regimen are about to begin, said Dr. Terry B. Strom, director of the Transplant Research Center.

“We have tried something like this for monkey models,” he said. “The results have been very good.”

The next step will be tests to ensure that the regimen is safe for human use.

“We anticipate toxicology trials very soon,” Strom said. “We are making the proteins needed for those trials.”

The fact that success was achieved in the mice trials with a relatively short course of treatment indicates that, for humans, “one might be able to use relatively brief periods of treatment to restore normal function,” he said.

source: HealthDay News

Detroit-based drug firm gets FDA approval for diabetes med Repaglinide Tablets USP

Wednesday, August 1st, 2007


Caraco Pharmaceutical Laboratories Ltd. said it received tentative approval from the United States Food and Drug Administration for the company’s Abbreviated New Drug Application for Repaglinide Tablets USP.


The Detroit-based generic drug company said Repaglinide works by lowering the blood glucose in patients with type 2 diabetes whose hyperglycemia can’t be controlled properly by diet and exercise alone.

Caraco, whose majority owner is Sun Pharmaceutical Industries Ltd. of Mumbai, India, said doses that were approved the by FDA were 0.5 mg, 1 mg and 2 mg tablets. The tentative approval is the bioequivalent to Prandin ®, registered trademark of Novo Nordisk Pharmaceuticals Inc.

“We are extremely pleased to receive this tentative approval,” said Daniel Movens, Caraco’s Chief Executive Officer in a statement. “We believe we have a first to file position on Repaglinide, which could result in 180-day marketing exclusivity. The product was filed with a Paragraph IV certification that we do not infringe and or that the Novo Nordisk patent is invalid. We are under current litigation with Novo Nordisk and expect a favorable conclusion.”

Leaping Lizards: A Diabetes Drug That Causes Weight Loss

Friday, July 27th, 2007

The Gila monster is a squat, ugly-looking lizard of the southwestern United States and Mexico known for its deadly venom. But for some Type 2 diabetics, the Gila monster’s poison just got a little sweeter.
It turns out that Byetta, a drug whose active ingredient is the synthetic version of a protein produced in the spit of the Gila monster, has been found to cause considerable weight loss in some of its users.

Eli Lilly and Amylin, who jointly market Byetta, sponsored research in which 200 patients taking the drug were followed for three years. The results of the study were presented this week at the American Diabetes Association’s annual conference in Chicago.

The patients lost an average of 11 pounds, with the most pounds shed in the first year. Considering that the average BMI of patients in the study was 33.5, the weight loss was described as “modest” by lead researcher John Buse, chief of endocrinology at the University of North Carolina-Chapel Hill’s School of Medicine.

Still, the findings are promising for sufferers of Type 2 diabetes; obesity is a major contributor to the disease, and some diabetes treatments can cause weight gain. “None of [the other diabetes drugs] are associated with weight loss” notes Buse.

Byetta is a self-injected synthetic hormone that was approved by the U.S. Food and Drug Administration in 2005. It was developed after John Eng, an endocrinologist at New York City’s Bronx VA Medical Center, convinced Amilyn and Eli Lilly of the potentially therapeutic benefits of a protein he had discovered in the Gila monster’s saliva.

In addition to boosting insulin production in patients, Byetta curbs the rate at which the stomach empties itself and may interact with the region of the brain responsible for the sensation of fullness.

Source

Anti-malarial drugs for diabetes cure

Wednesday, July 11th, 2007

Preliminary research has suggested that use of the anti-malarial drug hydroxychloroquine may help reduce the risk of patients with rheumatoid arthritis developing diabetes.

Type 2 diabetes mellitus affects nearly 8 percent of US adults, and its prevalence has been increasing.

Antimalarials such as hydroxychloroquine, a long-standing safe and inexpensive treatment for an autoimmune disease such as rheumatoid arthritis, theoretically may improve glucose tolerance and prevent diabetes mellitus, according to background information in the article. In vitro and animal studies indicate that antimalarials improve insulin secretion and peripheral insulin sensitivity.

Mary Chester M. Wasko, M.D., M.Sc., of the University of Pittsburgh, Pa., and colleagues examined the association between hydroxychloroquine therapy and risk of diabetes in patients with rheumatoid arthritis.

During the observation period, incident diagnoses of diabetes were reported by 54 patients who had taken hydroxychloroquine and by 171 patients who had never taken it. Analysis indicated that patients who had taken hydroxychloroquine had a 38 percent lower risk of developing diabetes, compared with those who had not taken hydroxychloroquine. This risk was further reduced with increased duration of hydroxychloroquine use. Patients who took hydroxychloroquine for more than four years had a 77 percent lower risk of diabetes compared with those who had never taken hydroxychloroquine.

“We report herein the first evidence, to our knowledge, suggesting that use of hydroxychloroquine is associated with a reduced risk of developing diabetes in patients with rheumatoid arthritis. Moreover, risk reduction increased with duration of hydroxychloroquine exposure, supporting a biological action of this drug on glucose metabolism,” the authors wrote.

The researchers also said that ‘anti-malarial drugs may have a role in treating rheumatoid arthritis not only to suppress synovitis [inflammation around the joints] but also to reduce the likelihood of developing glucose intolerance and dyslipidemia [abnormal concentrations of lipids’.

“While our study showed a reduction in diabetes incidence specifically in a rheumatoid arthritis cohort taking hydroxychloroquine, these findings also may be expected to occur in patients without rheumatoid arthritis. The beneficial changes in glucose metabolism and insulin sensitivity reported among patients with lupus, patients with type 2 diabetes, and in animal models suggest that these effects are not specific to rheumatoid arthritis.”

“Anti-malarial drugs may have a role in treating rheumatoid arthritis not only to suppress synovitis [inflammation around the joints] but also to reduce the likelihood of developing glucose intolerance and dyslipidemia [abnormal concentrations of lipids]. As quality of life and life expectancy improve for patients with rheumatoid arthritis, and health care costs escalate, the use of inexpensive, safe therapies that have multiple beneficial effects is attractive. Further prospective studies are needed to determine whether this treatment option should be considered a standard component of rheumatoid arthritis combination therapy in the future, and to evaluate the potential role of hydroxychloroquine as a preventive agent for diabetes among high-risk individuals in the general population,” the researchers concluded.

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Gestational diabetes puts babies at risk

Wednesday, July 11th, 2007

Women with gestational diabetes, a form of the disease that occurs during pregnancy and usually disappears afterward, risk having babies who are born oversized, with excess insulin, low blood sugar and possibly breathing problems.

But the risks to their babies may start to rise earlier than previously realized, even when the mother’s blood sugar levels are within what is now considered the normal range for pregnancy, says research presented at a meeting of the American Diabetes Association in Chicago.

In a study of 23,325 women, scientists at Northwestern University found that as a mother’s blood sugar rises, the risks of having a large baby, a cesarean delivery or low blood sugar in the newborn all increased. Researchers could not say at what point increased blood sugar should trigger medical treatment, but they say the level at which gestational diabetes is diagnosed likely will be lowered based on these findings.

Other topics discussed at the meeting, ending Tuesday:

Diabetes management. Many diabetics can’t get blood sugar levels to a safe range even with drugs, but some doctors fear that more aggressive treatment could cause extreme drops in sugar levels that can lead to coma. But a new study followed 8,641 patients at a hospital and found no association between intensification of treatment and hypoglycemia. It concludes that there is no reason to temper efforts to improve sugar control.

Diabetic complications. A new study found hearing loss is more common among people with diabetes, although the reasons are not clear. Another report says cases of diabetic retinopathy, a leading cause of blindness, could triple from 5.8 million in 2005 to 17.7 million in 2050.

Drugs. Studies involving drugs that act on gut hormones to improve the balance between insulin and blood sugars offer new information on their safety and versatility. These new drugs act when blood sugars are too high and turn off when levels get back to normal, reducing the risk of low sugar levels. Merck presented studies showing that Januvia, licensed in October, is safe when used as long as two years and as a first-line treatment in combination with metformin. Novo Nordisk studies showed that its experimental drug, liraglutide, safely reduces blood sugar levels with the added benefit of weight loss and requires no dosing changes in patients who have kidney or liver problems. The company plans to submit a license application early next year to federal regulators.

source

Pumpkin could hold key to diabetes treatment

Wednesday, July 11th, 2007

Pumpkin could “drastically” reduce the need for daily insulin injections for diabetics, according to recent research.

    Scientists found a compound in pumpkin that has been found to promote the regeneration of damaged insulin-producing beta cells in diabetic rats, thereby improving the level of insulin in their blood.

    Laboratory data showed that diabetic rats that had been fed pumpkin extract had only 5 percent less plasma insulin and 8 percent fewer insulin-positive cells than normal healthy rats, according to a research paper published this week in the US-based Journal of the Science of Food and Agriculture.

    The researchers fed 12 diabetic rats and 12 normal rats either a normal diet or a diet supplemented with pumpkin extract for 30 days.

    On average, the rats receiving the pumpkin supplements experienced a 36 percent increase in plasma insulin compared to the untreated rats, according to Xia Tao, the paper’s lead author and a teacher at Shanghai’s East China Normal University.

    However, Xia, a professor at the College of Life Science, emphasized that further research was needed to evaluate the effects in human beings.

    ”But I tend to believe pumpkin extract could also promote regeneration of pancreatic beta cells in humans,” he told the newspaper. “It is certain pumpkin can benefit diabetics by lowering blood sugar levels.”

    The professor added that the results were in line with the traditional Chinese idea that “pumpkin is a good food for diabetics”.

    ”However, no scientific proof was ever provided,” he said.

    Last year, Xia and his colleagues published a paper in the England-based Journal of Pharmacy and Pharmacology about D-chiro-inositol, a molecule that mediat?s insulin activity, in pumpkin. The newest research has further strengthened his belief in the potential benefits of a pumpkin-rich diet.

    Though they only experimented on rats with Type I diabetes, the researchers believe pumpkin extract will also help treat Type II because “it can allow regeneration of beta cells, which is also important in type II recovery,” Xia said.

    David Bender, sub-dean at the Royal Free and University College Medical School in London, told the US-based science magazine Chemistry & Industry that the research is “very exciting” in that “pumpkin may be a source of medicine to take by mouth.”

    Xia said he and his research group had also discovered the health benefits of several other plants and would soon release their findings.

    Diabetes is a disorder in which the body has trouble regulating blood glucose levels. The disease affects more than 230 million people, almost 6 percent of the world’s adult population, according to the World Diabetes Foundation.
    (Source: China Daily)

Drinking more milk may lessen type 2 diabetes risk

Wednesday, July 11th, 2007

A new research has found that combination of calcium and vitamin D may offer protection against type 2 diabetes.

The research, conducted at Tufts University, suggests that drinking more milk, a leading source of calcium and vitamin D in the diet, could help lessen the risk of type 2 diabetes by nearly 15 percent.

In the detailed analysis of previously published studies, the researchers found that persistently low levels of vitamin D were linked to as high as 46 percent greater risk of type 2 diabetes. However, increasing vitamin D only would likely have little effect in healthy adults. As an alternative, the researchers suggested that a combination of vitamin D and calcium, like that found in milk, would have the greatest potential to help prevent diabetes, especially among those at highest risk for the disease.

Examining the intake of milk and milk products exclusively, the researchers found that there was nearly a 15 percent lower risk for type 2 diabetes among individuals with the highest dairy intake (3-5 servings per day) compared to those getting less than 1 1/2 servings each day.

The Tufts researchers suggest that calcium and vitamin D may affect the body’s ability to generate or utilize insulin, the hormone the body makes to process sugar that is impaired in those with diabetes and pre-diabetes.

Beside calcium and vitamin D, milk is the primary beverage source of magnesium, which a second meta-analysis found may also decrease the risk of type 2 diabetes (2). The analysis concludes that for every 100 milligram increase in magnesium up to the recommended dietary intake, the risk of developing type 2 diabetes decreased by 15 percent.

Type 2 diabetes and insulin resistance syndrome (or pre-diabetes) influence an astounding 75 million Americans and death rates from diabetes have increased nearly 45 percent over the past 20 years, uplifting the significance of finding new ways to treat and prevent this lethal disease. The recommended three servings of lowfat or fat-free milk provides 900 mg of calcium, 300 IU of vitamin D and 80 mg of magnesium daily.

The new meta-analysis and review is published in the Journal of Clinical Endocrinology and Metabolism (1).

Source: Dailyindia.com

Selenium Supplements May Raise Diabetes Risk

Tuesday, July 10th, 2007

In the Quest to Fend Off Cancer, Some May Be Opening Door to Diabetes

While selenium supplements have been touted as a preventative measure for conditions ranging from cold sores to cancer, those who take the pills daily may be getting more than they bargained for when it comes to diabetes.

Specifically, people taking selenium supplements daily over a period of years may be putting themselves at a 50 percent higher risk of developing type II diabetes than those who do not, new research suggests.
The analysis, published on the Annals of Internal Medicine Web site Tuesday, used data from the Nutritional Prevention of Cancer Trial (NPC), a large clinical trial designed to determine whether selenium supplements prevent skin cancer.

Researchers selected more than 1,200 participants from the study who were initially diabetes-free. Half took a 200-microgram selenium supplement daily for an average of nearly eight years, while half received a placebo pill over the same duration.

What researchers found was that those taking the actual selenium supplements actually increased their risk of developing type II diabetes by about 50 percent.

Lead study author Dr. Saverio Stranges of Warwick Medical School, UK, said that the findings from this study suggest that selenium supplements do not prevent diabetes and that they might be harmful.

“At this time, the evidence that people should take selenium supplements is extremely limited,” Stranges said in a press release issued Monday. “We have observed an increased risk for diabetes over the long term in the group of participants who took selenium supplements.”

Study co-author James Marshall, senior vice president for cancer prevention and professor of urology at the Roswell Park Cancer Institute in Buffalo, N.Y., told ABCNews.com that the finding is of particular interest because of a widespread belief that loading up on antioxidants such as selenium invariably protects against a host of ills.

“The idea that people should just go out and start taking selenium in large amounts, willy-nilly, seems not to be sensible,” he said. “Fifty percent risk is not trivial.”

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tudy Involving Cord Blood Transfusion Shows Promise in Type 1 Diabetes

Monday, July 2nd, 2007

A pilot study researching the effect of stem cells from umbilical cord blood on children with type 1 diabetes was presented at the American Diabetes Association’s 67th Annual Scientific Sessions in June 2007. The study compared two groups of children diagnosed with type 1 diabetes. The first group received transfusions of their own umbilical cord blood that had been banked when they were born. The second group was the control group. These were kids who were selected to match the first group as closely as possible in age and duration of their diabetes.
After a six month period, the kids who received the cord blood had lower average A1C levels and needed less insulin than the control group. Michael J. Haller, MD, Assistant Professor of Pediatric Endocrinology at the University of Florida College of Medicine, stated in the press release,

“After only six months, it is too early to tell how long the children will benefit from this therapy, but early signs indicate that it may have helped enhance blood glucose control and management.”

Although the transfusions of cord blood didn’t make the diabetes go away, but it did seem to preserve the children’s own insulin production longer than expected. Dr Haller further explained,

“Our preliminary data showing lower A1Cs, lower average insulin requirements, and possible preservation of Cpeptide suggest a beneficial effect of autologous umbilical cord transfusion in youngsters with recent onset type 1 diabetes. Considerable research today is seeking to delay complete beta cell loss, and this may be one effective approach for children who have their own cord blood, who are newly diagnosed with type 1, and who enter clinical trials.”

The underlying objective of the study is to isolate the component in the cord blood that was effective in lowering A1C and slowing progression of the disease. The scientists hope that finding the cell type and recreating it will make the benefits available to more people.

Source

Plate aids diabetes weight loss

Wednesday, June 27th, 2007

Using a simple portion control dinner plate can help people with type 2 diabetes lose weight and decrease reliance on medication, research shows.

Canadian researchers put people with type 2 diabetes on a calorie-controlled diet for six months.

They found 17% of those who used a calibrated diet plate lost more than 5% of their body weight, compared with just 4.5% who did not.

The study appears in the journal Archives of Internal Medicine.
In the majority of cases type 2 diabetes is linked to carrying excess weight - 80% of people are overweight at diagnosis, and doctors recognise that weight loss can greatly improve the condition.

However, many people with diabetes find it hard to stick to a weight loss regime.

The researchers tested the effect of using a calibrated dinner plate and breakfast bowl that helps people to eat healthy sized portions.

On average those who used the diet plates lost 1.75% of their body weight, compared with just 0.05% in the group who had to rely on will power alone.

As a result, they were also much more likely to be able to decrease their reliance on diabetes-controlling medication, including shots of insulin.

As good as drugs

Lead researcher Dr Sue Pederson said the results were comparable to those achieved by taking expensive weight loss drugs.

She said: “The weight loss results are all the more impressive considering that diabetics in general do not respond well to weight loss programmes.”

Dr Ian Campbell, medical director of the charity Weight Concern, said: “Losing weight is never easy and even harder for diabetics.

“To achieve these results over a six month period is excellent and with no more side effects than an occasional decrease in blood glucose, easily corrected by a reduction in medication, is very impressive indeed.”

Tracy Kelly, of the charity Diabetes UK, said eating a healthy balanced diet and taking regular physical activity were the best ways of controlling weight and effectively managing diabetes.

“Cutting down on portion sizes and eating balanced meals will help people control their weight, therefore some people may find this plate useful.

“However, controlling weight can be achieved effectively without spending extra money.

“A healthy balanced diet should be based on carbohydrates and be low in fat, sugar and salt with plenty of fruit and vegetables.”

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