Wednesday, 6 July 2011

New Update for Diabetes Mellitus

Iwas trying to implement this new trick and tip to my blog. I previously looking for more efficient and effective way to shorten my post, or should I say, to beautify it. Nevertheless, this post is all about new update for Diabetes Melityus, taken from several sources. Feel free to browse it then.

Advances in Treating Type 1 Diabetes: Drugs Show Promise for Preserving Body’s Ability to Produce Insulin
Researchers Continue to Assess Dosage, Side Effects and Timing of Treatment after Diagnosis – Not All Studies Had Positive Effect

About Advances in Treating Type 1 Diabetes: Drugs Show Promise for Preserving Body’s Ability to Produce Insulin

San Diego, CA June 28, 2011

The progression of type 1 diabetes may be slowed in those newly diagnosed, through the use of promising new medications currently under development, according to data presented by researchers at the American Diabetes Association’s 71st Scientific Sessions®. Researchers believe these findings could eventually lead to the development of drugs to prevent or treat type 1 diabetes, since current work focuses on preserving beta cell function and prolonging the body’s ability to produce its own insulin.

A total of eight studies of therapies in various stages of clinical development will be presented at symposia here Monday and Tuesday. They represent a mix of trials funded by government agencies and those sponsored by biotechnology and pharmaceutical developers. All of the studies look at the potential for preventing the slow loss of insulin production that occurs within the first several months following the diagnosis of type 1 diabetes.

“Presenting the findings together gives researchers an opportunity to discuss what worked in this approach to treating type 1 diabetes, what didn’t, and why,” said Kevan Herold, MD, co-chair of the Tuesday symposium and Professor of Immunobiology at Yale University . “We can see that some drugs are successful in slowing the progression of this disease, but thus far we have not been able to prolong that effect permanently. Others are not as effective and some have not been effective at all outside the laboratory setting. Hopefully this discussion will help us to determine the best way to move forward as we continue to explore this promising direction of preserving beta cell function, which is critical to ultimately finding a cure.”


The drug, DiaPep277, a potential vaccine for type 1 diabetes, was developed with the goal of preventing beta cell destruction. During the development of type 1 diabetes, it is believed that an increase in a protein in the beta cell called “heat shock” protein causes beta cell destruction through activation of destructive T-cells. However, part of this protein has the ability to change the destructive T-cells into protective T-cells.

Researchers therefore removed 24 of 500 amino acids from the “heat shock” protein, to see if doing so would protect beta cells from attack by the T-cells, a hypothesis that had previously held true in studies conducted in laboratory mice with a form of diabetes similar to human type 1 diabetes.

In this phase two study, the altered “heat shock” protein (known as DiaPep277) – administered subcutaneously to 100 patients newly diagnosed with type 1 diabetes – succeeded in protecting the beta cells, replicating in humans the findings in laboratory mice. “The drug works by increasing protective T-cells that secrete cytokine, which prevents the destruction of beta cells from immune attack,” said lead researcher Itamar Raz, MD, Professor of Medicine and Head of the Hadassah Diabetic Center in Jerusalem, Hadassah Hebrew University Hospital.

Administering this vaccine also allowed beta cells to continue to secrete insulin for up to two years following a type 1 diagnosis, he said, a promising result that points toward the potential for prevention. “This shows that the vaccine protects the beta cell function over time,” Raz said.

The drug is currently undergoing phase three trials in which beta cell function, insulin use and glucose control are being monitored as key outcomes.


Previous trials of teplizumab found that giving a 14-day course of this drug to people ages 8-30 years who were newly diagnosed with type 1 diabetes preserved beta cell function for 12 months or longer, but that the effects of the drug began to wane about a year after receiving it. This phase two study looked at whether giving a second course of the drug intravenously a year after it was first administered could prolong its effects.

While it was unclear as to whether the second course of the drug provided any additional benefit, the study did confirm that those who were given teplizumab, an anti-CD3 medication (which modulates T-cells), did continue to show improved beta cell function even two years after diagnosis, over those not given any medication, said lead researcher Kevan Herold, MD. Researchers are continuing to analyze data that will help them compare the benefit of receiving one course of the drug with that of two courses.

The data showed that those who received teplizumab experienced a 45 percent decrease in beta cell function over two years, compared to a 77 percent decrease for those in the untreated group, he said. In addition, at 24 months, the untreated group used 57 percent greater amounts of insulin, on average, than the group that received medication.

“The effect seemed to be most pronounced from the first course of the drug,” Herold said. “It also seemed to be effective in younger subjects, age 8-12.”

In summary, Herold said, the study answered the question: “Can your body make more insulin as a result of having had this treatment? Yes, it can.”


In this phase three trial of an anti-CD3 drug, researchers administered substantially lower doses of the medication (one-sixteenth the dose administered in previous trials, where significant side effects were seen) to see if reducing the dose would reduce side effects while maintaining a benefit in insulin production. Previous investigations have shown that maintaining a certain level of C-peptide can reduce future complications, prevent hypoglycemia and improve A1C levels.

Though previous trials did find that otelixizumab was effective in preserving C-peptide, it was not effective in doing so at the lower dose, said Peter Gottlieb, MD, co-investigator of the study, which examined the effect of otelixizumab on those newly diagnosed with type 1 diabetes between the ages of 12 and 44 years.

“The dose that was chosen was clearly too low,” Gottlieb said. “Future trials using a dose between the two previous ones may be useful in reaching the desired therapeutic goal.”


This phase three, double-blind, placebo-controlled, multinational study of the anti-CD3 drug teplizumab had a combined goal of reducing A1C to less than 6.5 percent for those newly diagnosed with type 1 diabetes and reducing the amount of insulin needed to less than 0.5 units per kg of body weight per day. Though the study did not achieve this combined goal, it did have some positive results, according to lead researcher Nicole Sherry, MD, Director of the Diabetes Center at the Massachusetts General Hospital for Children in Boston.

Five percent of participants who received treatment no longer needed insulin at the end of one year, compared to none of those who received a placebo, she said. In post-hoc analysis, 40 percent of those who received a 14-day regimen of the drug experienced a preservation of or increase in C-peptide levels, compared to 28 percent of those in the placebo group.

“We found an especially potent effect in certain subgroups,” Sherry said, “namely children, participants in the United States and those who were treated within six weeks of their diagnosis.”

CTLA4Ig/Abatacept (Orencia)

This phase two, randomized clinical study compared the effects of the drug abatacept to placebo in people newly diagnosed with type 1 diabetes, ages 6 to 45 years. It found that those who received the drug experienced a 59 percent higher level of C-peptide at the end of two years, compared to those who received placebo. The drug was first given to people within three months of diagnosis. The study showed that on average it preserved beta cell function for an additional 9.6 months.

Jay Skyler, MD, chairman of the National Institutes of Health (NIH)-funded Type 1 Diabetes TrialNet study group, which conducted the study, said while the results were positive, it is only a step in the right direction.

“The problem is, in spite of giving the drug for two years we only had a 9.6-month delay,” he said. “That means that the effect over time may have been lost. It may have had an effect early on that created the delay and then may have lost further effect as time went on.”

The medication, he added, was noted to be less convenient to administer as it need to be given in 27 separate intravenous infusions over a two-year period of time. The company is currently working on a subcutaneous (under the skin) form of the medication that would be easier to administer, he added.


In this TrialNet study of 145 people newly diagnosed with type 1 diabetes as young as age 3 (and as old as age 45), participants were randomized into one of three groups: those given an injection of the GAD65 vaccine plus two boosters; those given an injection, one booster and one placebo; and those given all placebos.

However, all three groups experienced identical effects, said Skyler. That is, there was no benefit at all from taking the medication. The positive news was that there did not appear to be any side effects either, he said.

“What we don’t know is whether in a different dosage or on a different dosage schedule, we would have seen an effect,” he said. “When you don’t see something, you’re not sure if it’s because of giving the wrong amounts or if it just doesn’t work.”

The medication has worked well in previous animal studies, he noted.

Interleukin-2 in Combination with Rapamycin (Sirolimus)

In this phase one safety trial of nine people previously diagnosed with type 1 diabetes (who had lived with the disease for up to four years), researchers tested the safety of combining two Food and Drug Administration (FDA)-approved drugs that are currently being used to treat other diseases.

Previous studies in laboratory animals had suggested that these drugs (Interleukin-2, used to treat cancer, and Rapamycin, which is used in organ transplantation), when used together, could turn off the immune attack on the beta cells. However, when tested in humans, the same effect did not occur. But, there were positive changes to the immune system that suggested that this approach could still be useful, said Carla Greenbaum, MD, lead investigator on the study. Researchers are continuing to analyze data to better understand these findings.


Calories, Not Protein or Carbs, Are Key to Weight Loss: Study
Diabetics gained similar benefits from low-fat diet emphasizing either proteins or carbohydrates

About Calories, Not Protein or Carbs, Are Key to Weight Loss: Study

SUNDAY, June 26 (HealthDay News) -- Curbing calories is the key ingredient for diabetics seeking to lose weight, and low-fat diets that are either high in protein or high in carbs are equally effective, researchers say.

"I think there are two key messages from this study," said study lead author Jeremy D. Krebs, a senior lecturer with the school of medicine and health sciences at the University of Otago in Wellington, New Zealand. "The first is that no matter what diet we prescribe, people find it extremely difficult to sustain the changes from their habitual diet over a long time. But if they are able to follow either a high-protein diet or a high-carbohydrate diet, they can achieve modest weight loss."

Krebs said this first message conveys flexibility and allows people to choose the approach that best suits them and "even to swap between dietary approaches when they get bored."

The second point "is that for people with diabetes, if they can adhere to either diet and achieve weight loss, then they do get benefits in terms of their diabetes control and cardiovascular risk," he added.

Krebs and his colleagues are scheduled to report their findings Sunday in San Diego at the American Diabetes Association meeting.

To compare the potential benefits of two popular dietetic approaches, the authors tracked nearly 300 overweight men and women between the ages of 35 and 75 who were on a new, two-year nutritional program.

To start, all the participants had a body mass index greater than 27, meaning they were moderately overweight, and all had type 2 diabetes.

The researchers randomly assigned the participants to one of two groups: a low-fat/high-protein group or a low-fat/high-carb group.

For the first half year, all attended twice-weekly group sessions led by a dietitian; for the following six months, sessions took place monthly.

Weight and waist circumference were measured at six months, one year, and two years. Kidney function and lipid (blood fats) profiles were also assessed throughout.

Food diaries indicated that total calorie intake went down in both groups. Ultimately, both groups lost a similar amount of weight and reduced their waist size in similar measure, the investigators found. And by the end of the two-year period, both groups had similar blood fat profiles.

Krebs and his colleagues concluded that their "real-world" experiment demonstrated that both approaches afford similar benefits, with the principal driving factor behind sustained weight loss being calorie reduction rather than either high-carb or high-protein consumption.

Lona Sandon, a registered dietitian and assistant professor of clinical nutrition at the University of Texas Southwestern Medical Center at Dallas, said the observations were "not at all surprising."

"This is pretty consistent with other research out there that has conducted other long-term comparisons in the general population," she said. "In the first six months you might see a little better benefit from a high-protein approach. But long-term, the initial benefits from a high-protein diet seem to diminish over time, and the two diets end up being essentially equivalent," Sandon explained.

"The bottom-line is that the issue for weight loss is calories," Sandon added. "Not where those calories come from. You need to create an energy deficit to lead to weight loss, and that happens by decreasing those calories. That's just been shown again and again."

Experts note that research presented at medical meetings is considered preliminary because it has not been subjected to the rigorous scrutiny required for publication in a peer-reviewed medical journal.

SOURCES: Jeremy D. Krebs, senior lecturer, school of medicine and health sciences, University of Otago, Wellington, New Zealand; Lona Sandon, R.D., assistant professor, clinical nutrition, University of Texas Southwestern Medical Center at Dallas; June 24-28, 2011, American Diabetes Association annual meeting, San Diego


After Diabetes Diagnosis, Concentrate on Dietary Changes, Study Says
Exercise made little difference in first year of treatment, researchers found

About After Diabetes Diagnosis, Concentrate on Dietary Changes, Study Says

SATURDAY, June 25 (HealthDay News) -- Dietary changes alone can yield the same benefits as changes in both diet and exercise in the first year after a person is diagnosed with type 2 diabetes, a new study contends.

English researchers found that patients who were encouraged to lose weight by modifying their diet with the help of a dietician had the same improvements in blood sugar (glycemic) control, weight loss, cholesterol and triglyceride levels as those who changed both their diet and physical activity levels (30 minutes of brisk walking five times a week).

Both groups achieved about a 10 percent improvement in blood sugar control, cholesterol and triglyceride levels compared to patients who received routine care. The two intervention groups also lost an average of 4 percent of their body weight, while those in a routine care group had little or no weight loss.

Patients in the routine care group were also three times more likely than those in the intervention groups to start on diabetes medication before the end of the study.

"Getting people to exercise is quite difficult, and can be expensive," lead researcher Rob Andrews, a senior lecturer at the University of Bristol, said in an American Diabetes Association news release. "What this study tells us is that if you only have a limited amount of money, in that first year of diagnosis, you should focus on getting the diet right."

He pointed out, however, that the study participants with type 2 diabetes preferred to engage in both exercise and dietary changes. "They found diet alone quite negative," he said. One reason they might not have seen an additional benefit from exercise, he added, "is because people often make a trade. That is, if they go to the gym, then they feel as if they can have a treat. That could be why we saw no difference in the weight loss for the diet plus exercise group."

Andrews suggested that future research focus on determining whether adding exercise at a later time would make more of a difference.

"[Blood glucose] control gets worse over time. In the early stages, people tend to make rapid improvements and then it stays the same for a while. Adding exercise later might provide another boost in control whereas it wouldn't early on," Andrews said.

The study results were slated to be reported June 24 at a symposium run by the ADA and The Lancet at the ADA's Scientific Sessions meeting in San Diego.

A second study to be presented at the symposium found that intensive treatment of type 2 diabetes led to a slight reduction in cardiovascular disease risk factors.

For that study, nearly half a million people in Denmark, the Netherlands and the United Kingdom were screened for diabetes. The 3,057 people who were found to have the disease were assigned to receive either intensive treatment or routine care.

Intensive treatment included lifestyle changes (quitting smoking, healthier eating, more physical activity), aspirin treatment, and intensive medication treatment for blood pressure, blood sugar and lipids (blood fats). Those assigned to routine care were instructed to use national guidelines for advice on lifestyle and medical treatment.

Patients in the intensive treatment group showed clinically significant reductions in blood pressure and cholesterol and small decreases in weight and blood sugar levels maintained over a five-year period. The differences were greatest in the reducing the risk of heart attack and smallest in reducing the risk of stroke.

There were no statistically significant differences between the two groups in rates of heart attack, stroke, cardiovascular deaths or revascularization, according to the news release.

Experts noted that research presented at medical meetings is considered preliminary because it has not been subjected to the rigorous scrutiny required for publication in a medical journal.

SOURCE: American Diabetes Association, news release, June 25, 2011


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