Early Treatment Of Type 2 Diabetes Studied

Will early treatment of Type 2 diabetes with one of three different drugs delay or prevent complications and prevent decline in beta cell function? And if so, which drug? 

A major study to determine this question comparing a new drug Avandia with metformin and a sulfonylurea has just been announced. Avandia is a new thiazolidinedione (TZD), a class of oral diabetes drugs, that causes cells in the body to be more sensitive to insulin, thus directly targeting insulin resistance, one of the underlying causes of diabetes. 

The study is called A Diabetes Outcome Progression Trial (ADOPT). It will be the first to compare Avandia (a TZD) to metformin or a sulfonylurea, which are older medications used to treat the symptoms of the disease but not insulin resistance. This large, four-year study will be the first of this scope initiated since the UK Prospective Diabetes Study (UKPDS) which first showed that patients were best managed through a combination of diet, exercise and early intervention with traditional oral medications. In spite of this aggressive treatment, most patients still developed serious complications and lost beta cell production of insulin. Because of the way it works, the recently developed Avandia may offer long term blood sugar control and delay the progression of diabetes. 

What is the scope of ADOPT? This phase IV, randomized, double-blind, four-year study conducted in 300 sites worldwide will study more than 3,500 people with Type 2 diabetes diagnosed less than two years ago. The people in the study also must have received no previous treatment with an oral diabetes medication. Participants will be randomized to one of three treatment groups: Avandia, metformin, or glyburide (glibenclamide in Europe). The primary goal of the study is to compare the metabolic effects of long-term treatment in people with recently diagnosed Type 2 diabetes. Other goals include determining the long-term effects of each drug on blood sugar control, beta-cell function, insulin sensitivity, safety for the liver, cardiovascular and hematological systems, microalbuminuria, cardiovascular risks, and quality of life. 

In Type 2 diabetes, the pancreas often produces enough insulin, but the body uses it inefficiently. Avandia helps the body use its own natural insulin effectively by reducing insulin resistance. The older therapies for Type 2 it is being compared with work differently. Metformin reduces glucose output from the liver and sulfonylureas stimulate the pancreas to produce more insulin.

Tamiflu Lessens Flu Symptoms

Tamiflu, in a new class of drugs called neuraminidase inhibitors, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of influenza A&B, which includes the common flu. The new drug, developed by Hoffman-La Roche and Gilead Sciences, will be available when this year's flu season arrives. 

Tamiflu is effective for treating flu infection in adults who have had symptoms for no more than two days. Over-the-counter medications only mask the symptoms of flu, but Tamiflu, an antiviral agent, stops the actual flu virus from replicating from cell to cell. 

A group of 849 participants ages 18 through 65 were enrolled in clinial trials of Tamiflu in the U.S. and international sites. The double-blinded, placebo-controlled trials infected the participants with influenza and asked them to assess their flu symptoms as ``none'', ``mild'', ``moderate'' or ``severe''. The amount of time it took to improve was measured from the time treatment was initiated to the time when all symptoms were assessed as ``none'' or ``mild''. 

In studies using the recommended dose, there was a 1.3 day (30%) reduction in the median time to improvement in participants receiving Tamiflu compared to participants receiving placebo. The most frequently reported side effects from Tamiflu were mild to moderate nausea and vomiting, which can be lessened when Tamiflu is taken with food. Less than 1% of participants quit the trials early due to nausea and vomiting. 

Otherwise healthy elderly patients, 65 and older, given the recommended dose of Tamiflu showed a reduction in the duration of flu similar to that seen in younger adults. Also, no overall difference in safety was observed in clinical trials between the elderly patients and younger adults, and no dose adjustments are required.

In clinical studies, Tamiflu did not interfere with the antibody response to the influenza infection. People who have used Tamiflu should still receive the flu vaccine. See also our complete coverage of Cold and Flu Treatments.

Fat And Fit Is Fine

Contrary to recent dire research results, being obese doesn't have to be a tremendous health risk. In fact, according to recent research, if a person is obese but fit, they reduce their risk of dying early significantly. 

If Americans will just do more exercise, they don't have to worry so much about how much they weigh. Steven N. Blair and his colleagues at The Cooper Institute for Aerobics Research, Dallas, looked at data on 25,174 men over an average of 10 years. Thirteen percent were obese, 46 percent were overweight, and 41 percent had normal weight. As well as measuring their weight, their level of fitness was determined. About 50 percent of the obese men had low fitness. The results were contrary to expectation. 

Being unfit and being fat carry separate risks of dying early. Obese men with low fitness had 2.3 times the risk of dying compared with obese men who were not unfit. This observation means that a fat person can reduce some of their risk of dying simply by exercising regularly, even if they don't lose weight. Weight loss carries separate benefits from exercising. 

How risky is low fitness if you are obese? It carries about the same risk of dying as having cardiovascular disease, and considerably more risk than high blood pressure, high cholesterol and smoking. Obese men who started the study with cardiovascular disease had 2.4 times the risk of dying, compared with similar men who started the study without it. Obese men who had high cholesterol had a 70 percent greater risk of dying than did similar men without high cholesterol. Obese men with diabetes or who were current smokers had a 50 percent greater risk, and obese men with high blood pressure had a 10 percent greater risk.

This study provides some optimistic strategies in the battle for health. More people can benefit from becoming fit than from changing any of the other risk factors because more people are unfit than have diabetes, high cholesterol, high blood pressure or smoke. And, happily, exercising is an attainable goal for most people, where losing weight may not be. If a person loses some weight and becomes fit, the benefit is double. 

The results of this research appear in the recent issue of The Journal of the American Medical Association that carries many articles about obesity.

Diabetes Annihilating Pima Indians

Amputations, dialysis and blindness. These are the way of life as diabetes spreads among the 11,500 Pima Indians on a reservation south of Phoenix. As well as worrying about annihilation, tribal leaders claim government researchers contributed to the problem. 

In the last 35 years, diabetes among Pima Indians over 55 has escalated out of control to 80 percent from 45 percent, as reported by the National Institutes of Health. Now, tribal leaders are claiming that the NIH has been studying the connection between Pimas and diabetes all these years, but they haven't done enough to help the tribe avoid the ``Pima Plague." The NIH says they never promised the Pimas a cure. 

Even so, has the NIH done all it could to help the Pimas? An October 31st article in the Arizona Republic reports that interviews and government records show that the NIH decided to focus its resources in the late 70's and 80's on Type 1 diabetes, a form of diabetes commonly affecting whites. The Pimas suffer from Type 2 diabetes. Though methods to prevent Type 2 diabetes have been developed and tested over the years, NIH tested these methods elsewhere because of a decision to not fund the experiments among the Pimas. Not until three years ago did they begin testing prevention methods with the Pimas. 

In defense of NIH's decision to fund Type 1 research, Dr. Phillip Gorden, a director of diabetes research at the NIH, says the Type 1 study was easier to conduct because new methods for testing had just become available. Michael Mawby, the American Diabetes Association's vice president for governmental relations, counters this defense by saying the NIH had a moral obligation to help the Pimas. 

Dramatic changes in their lifestyles and diets which have caused obesity are acknowledged by the tribe as instrumental in the explosion of Type 2 diabetes. Since hunting and fishing have declined, they receive little exercise. Their centuries old diet of cholla cactus buds and jackrabbit has been replaced by the Western diet of fatty, processed foods. Obesity is rampant. Pima kindergartners too often weigh more than 75 pounds and adults more than 300.

Collaboration To Develop Diabetes Treatments

Abbott Laboratories and Karo Bio AB will collaborate for three years beginning January 1, 2000, to develop new treatments for Type 2 diabetes. In the collaboration, Abbott will use Karo Bio's proprietary technology in nuclear receptors and lead compounds to develop treatments in glucocorticoid receptor (GR) antagonists targeting the liver. 

The two companies will jointly manage the research and preclinical development. Abbott will manage clinical development and worldwide marketing of any resulting compounds for the treatment of diabetes. In exchange for this, Karo Bio will receive an initial payment, funding for research and development, milestone payments and royalties on eventual product sales. 

One method of treating Type 2 diabetes is shutting off the unnecessary production of glucose in the liver. In fact, over-production of liver glucose may be the major defect in Type 2 diabetes. Therefore, a treatment that decreases liver glucose production would be beneficial in Type 2 diabetes, and to a lesser degree, Type 1 . 

Glucocorticoids (e.g. cortisol) stimulate the production of new glucose by the liver. A GR antagonist would decrease this production, counteracting the increased glucose production by the liver in diabetes. The treatment may lead to normal blood glucose levels with little to no risk of hypoglycemia.

Chat With Foot Care Specialists

FootHealthNetwork.com will celebrate American Diabetes Month by hosting a live, informative chat on November 21, from 7:00 - 9:00 p.m. People with diabetes, as well as those who would like more information about diabetic foot prevention, can ask specific questions and in other ways participate in an informal session with Dr. Justin Wernick, D.P.M., past winner of the prestigious Podiatrist of the Year award, and Advisory Board Member to FootHealthNetwork.com. Jerome S. Klein, C.O., C. Ped., Director of Pedorthics at Apex. Foot Health Industries, Inc. will be joining in on the chat as well. 

FootHealthNetwork.com, a comprehensive foot health website, is so helpful and easy to use that only four days after it began, it received USA Today's ``hot site'' designation. It carries an extensive list of foot disorders described in non-technical terms, suggested solutions, and product recommendations. FootHealthNetwork.com can be accessed in English, Portuguese, French, Spanish, German and Italian. In addition to providing education, FootHealthNetwork.com creates forums for chatting with foot health professionals. A major goal is to eliminate unnecessary foot pain.

To learn more about the Live Diabetes Chat on November 21, visit http://www.FootHealthNetwork.com and click ``news and information'' or e-mail at info@foothealthnetwork.com.

The Diabetes Mall @ http://www.diabetesnet.com 
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