Monthly Archives: April, 2012

Does Naturopathy Help Diabetes?

Would you go to a naturopathic doctor if it would help you lower your HbA1c? A new joint study by researchers at the Group Health Research Institute and Bastyr University Research Institute has found that such an approach might help people with poorly controlled type 2 diabetes lower their blood sugar by twice as much as similar patients treated with conventional therapy alone.

More and more researchers from mainstream medicine are looking at combining conventional therapy with naturopathic care into what they call integrated therapies. Group Health Research Institute is the research arm of the 600,000 member Group-Health Co-op, a managed care health insurer in the Pacific Northwest affiliated with Kaiser Permanente of California. Bastyr University is a fully accredited naturopathic medical school that is a leader in natural health education.

The research team led by Bastyr’s Ryan Bradley, ND, MPH, director of the Center for Diabetes and Cardiovascular Wellness at Bastyr, found that patients with type 2 diabetes gained several benefits from the integrated therapy compared to patients treated with conventional therapy alone.

“The news is encouraging for those fighting the disease,” Bradley said in a press release. “Patients involved in the study cited the benefits of trying different approaches to find the best ways to minimize the effects of type 2 diabetes. In many ways, that strategy mirrors our partnership with Group Health in this research study—working together to discover the best possible solutions.”

In the study, 40 type 2 diabetes participants with an average HbA1c between 7.5 percent and 9.5 percent were counseled on diet, exercise and glucose monitoring by four naturopathic physicians in addition to conventional diabetes care from their medical doctors, including prescription medicines. In addition, many participants received stress management care and dietary supplements.

These 40 patients were compared to the medical records of a group of 329 Group Health patients with type 2 diabetes who received only conventional care. The results were published April 18, 2012, in the online journal BMC Complementary and Alternative Medicine.

At the end of six months and an average of 4 visits to their  naturopathic doctors, the researchers found that those in the integrated care group had dropped their blood sugar by an average of  1.0 percent compared to an average .05 percent decrease for those treated with conventional care. The difference persisted for 12 months following the study start, but was not as great and was no longer statistically significant at 12 months.

Changes in total cholesterol and blood pressure were not statistically different between the two groups, meaning the differences were not large enough to rule out the possibility that the differences were due to chance.

Nevertheless Bradley says the difference in blood sugar control were significant enough to warrant a larger comparison trial involving patients randomly assigned to each of the two treatment groups. Such a trial would be able to determine if the benefits shown in this study were due to the naturopathic counseling or whether the patients in the integrated care group were more motivated to control their blood sugar than their conventionally treated counterparts.

Victoza Wins Head-To-Head Battle With Januvia

If you take Victoza to help control your blood sugar for type 2 diabetes, you can now officially wear the foam finger proclaiming your team is number one.

The FDA this week approved an expanded label for Victoza showing data from two large trials that compared Victoza head-to-head with Januvia®. In both studies, Victoza won 2-0 for superior blood sugar control and weight loss.

Novo Nordisk announced the win for its once-daily injected drug in a press release. The approval allows the Victoza label to include data showing better blood sugar control and weight loss compared to Januvia.

The company’s Corporate Vice President for Diabetes Marketing Camille Lee is happy about the FDA’s action. “We’re pleased to expand the Victoza product label to include data demonstrating superior efficacy over Januvia,” Lee said. “The additional data supporting combination therapy with basal insulin further demonstrates that Victoza is an appropriate option for a wide variety of adults with type 2 diabetes.”

The two large studies showed that patients had an average reduction in blood sugar of 1.2 percent in one trial and 1.5 percent in the other compared to an average reduction of 0.9 percent in both trials for those taking Januvia.

When Victoza was added to treatment with metformin and Levemir (insulin) 43 percent of the patients achieved the American Diabetes Association target for blood sugar control of an HbA1c less than 7 percent after 26 weeks.

In addition, the people in the Victoza groups had an average weight loss of nearly 6 pounds in one trial and a little more than 7 pounds in the other trial compared to an average weight loss of 1.76 pounds for those taking Januvia. There were 665 people in one of the studies who took the drugs for six months, and 323 people took the drugs for that long in the other trial.

The most common side effect for the combination treatment of Victoza, metformin and insulin was diarrhea occurring in 11.7 percent in one trial and 6.9 percent in the other.

Despite its superior showing in weight loss, Victoza does not have FDA approval to sell the drug as a treatment for weight management. The weight loss results were obtained as a secondary aim of the studies.

Victoza, is the first human glucagon-like peptide-1 (GLP-1) drug that is 97 percent similar to natural human GLP-1. Like natural GLP-1, Victoza works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia.

There was no word on when Novo Nordisk might put Victoza’s once-daily treatment up against Amylin’s one-a-week Bydureon.

Will Albiglutide Be Approved?

British pharmaceutical company GlaxoSmithKline announced this week that it was ready to submit its once-weekly drug for controlling blood sugar for approval. The announcement came following the results of a series of clinical trials, called HARMONY, that have shown effectiveness without wowing investors.

As reported by MedPage Today and the Wall Street Journal, the trial results for HARMONY 6, released April 3, showed that albiglutide reduced HbA1c levels by .82 percent compared to a .66 percent reduction for patients taking insulin before meals.

In addition the patients taking albiglutide lost an average of 1.6 pounds compared to the insulin treated patients who gained 1.8 pounds. Side effects were nausea that occurred in 13 percent of those taking albiglutide compared to 2.1 percent of those taking insulin, and vomiting occurring in 7 percent of the albiglutide compared to 1.4 percent of the insulin group.

The company’s press release did not provide details about the trials, such as how many people were enrolled, or how long people were taking the drugs. And the results have not yet been published in medical journals. Nevertheless the results coupled with results of other HARMONY trials were sufficient to convince Glaxo that it could be successful in seeking approval to market the drug.

Albiglutide is similar to Victoza and Bydureon, in that it binds the glucagon-like peptide, or GLP-1, which stimulates the release of insulin when glucose levels become too high. Normally when food is eaten, GLP-1 is released into the blood by the intestine. It’s two main effects, according to Diabetesnet.com, are to slow the absorption of food in the intestine, and to stimulate the pancreas to boost insulin production.

But GLP-1 is like a catalyst, it works just long enough to trigger a reaction before it is broken down by another enzyme. GLP-1 agonists like Albiglutide or Victoza bind to GLP-1 in such a way as to protect it from being broken down, thus extending the length of time it remains effective in stimulating production of insulin.

According to MedPage Today, last November Glaxo released preliminary results from another trial in the HARMONY series, which found that albiglutide effectively reduced HbA1c, but was not as effective as liraglutide (Victoza).

As a result of these findings, The Wall Street Journal says investors are unimpressed with albiglutide, predicting sales might range from $250 million $750 million, which is considered modest by pharmaceutical industry standards.

Novo Nordisk’s Victoza led the introduction of GLP-1 agonists into the market with twice-daily injections. That was followed by Lyxumia from Sanofi and Byetta from Amylin and Lilly, which recently won approval for its once-a-week injection formulation named Bydureon.

Metformin Also Helps Pancreatic Cancer Patients

A new study shows that people with diabetes and pancreatic cancer may live longer if they take metformin. In fact, those prescribed metformin had a 32 percent lower risk for death compared to those who didn’t take metformin.

Whether taking metformin might prevent people with diabetes from developing pancreatic cancer, however, is unknown.

This is mostly because the relationship between diabetes and pancreatic cancer is unclear. While about 80 percent of those diagnosed with pancreatic cancer also have diabetes, researchers have been unable to determine if the diabetes causes the cancer, or whether the cancer causes the diabetes.

A 2003 review of multiple studies of the link between the two found that there is no simple answer to which is the cause and which is the result, and that neither theory excludes the possibility that pancreatic cancer is both caused by diabetes and causes diabetes.

In the new study published in the March 31, 2012 Clincal Cancer Research researchers led by Dr. Donghui Li, of MD Anderson Cancer Center reviewed the medical records of 302 patients diagnosed with pancreatic cancer. The found that one year after diagnosis 63.9 percent of the patients prescribed metformin were still alive compared to 46.3 percent of the group that were not given metformin.

After two years the contrast was even clearer with 30.1 percent of the metformin group surviving while 15.4 percent of the non-metformin group survived. Putting it another way, the midpoint of the survival range for the metformin group was 15.2 months compared to 11.1 months for those not prescribed metformin.

This effect of reducing the risk of death in these patients held true for all stages of cancer except the most advanced stage, in which the cancer has spread throughout the body. The researchers found no benefit for the metformin patients with such advanced cancer.

In an editorial accompanying the research study in the same issue, Dr. Michael Pollack of McGill University, Montreal, wrote that although the studies reviewed show clinical, drug and biologic evidence pointing to a protective effect of metformin, the only way to  determine conclusively whether metformin might be used to treat or prevent pancreatic cancer in diabetes patients is by conducting studies that compare patients treated with metformin to patients treated without metformin.

“Clinical trials that simply use metformin at antidiabetic doses in unselected cancer patients may or may not reveal benefit,” he wrote, “so carefully designed preclinical and clinical studies are needed for rigorous investigation of important details.”

Does Verapamil Help With Diabetes?

If you are a mouse with human pancreatic islet cells in your body, taking a common drug for high blood pressure appears to reverse the diabetes-related death of those islet cells, which is good news for mice involved in diabetes research.

The research team led by Dr. Anath Shalev, director of the University of Alabama Birmingham Comprehensive Diabetes Center, have found that the drug verapamil, which belongs to the family of high blood pressure medicines called calcium channel blockers, slows the progression of type 1 or 2 diabetes, at least in mice. But the authors think it may have clinical application in humans with diabetes, particularly since the drug is already FDA approved for high blood pressure. Their study appears in the March 22 issue of the journal Diabetes.

For more than a decade the authors have been studying how high blood sugar uniquely turns on a gene called TXNIP, short for thioredoxin-interacting protein,. They had earlier shown that excessive levels of this gene in diabetes causes cells to self-destruct. They also found that lowering TXNIP levels in heart muscle tissue reduces the damage caused by heart attacks. They were surprised, however, to find hints of verapamil’s effect amid their effort to design a drug to shut down TXNIP.

“We long have felt that finding an oral medication that inhibits beta cell TXNIP expression would represent a major breakthrough, and now we have the first study showing that a drug already proven safe in years of clinical practice may halt the development of diabetes,” senior author of the paper Shalev said in a prepared statement. “Our results are encouraging because patients with diabetes suffer from beta cell death as part of their disease, there has been no treatment targeting this problem and TXNIP-inhibition promises to reverse it.”

Islets are a group of cells found in the pancreas that secrete hormones into the blood stream. Beta cells are one type of islet cells that secrete insulin to control blood sugar levels. These  begin to die in both Type 1 and Type 2 diabetes as the disease progresses. No one suspected that calcium channel blockers might reverse beta cell death because the studies that led to their FDA approval measured their effect on heart attacks, not blood sugar.

In their experiments, Shalev’s team used molecular biology techniques to watch as production of TXNIP rose in beta cells to abnormal levels as mice became diabetic and then fell again as they received verapamil.

“The debate now should begin as to whether physicians should consider verapamil an additional treatment to protect beta cells in patients with both hypertension and diabetes, similar to the use of ACE inhibitors for kidney protection,” said Shalev, who also is a clinician. “As it stands, it can take years before patients with diabetes receive verapamil, possibly missing a window of opportunity. Future clinical studies need to test whether or not earlier treatment could have a profound effect on diabetes progression by saving more beta cells.”