I am diabetic

THURSDAY, Sept. 25 (HealthDay News) — One of a new class of diabetes drugs has done well in a trial conducted to help bring it to market, researchers report.

The drug, liraglutide, is a laboratory-made version of glucagon-like peptide-1 (GLP-1), a hormone produced by the body. Several members of the GLP-1 family are in clinical trials, and one already has been approved by the U.S. Food and Drug Administration.

In a phase 3 trial, usually the last kind done before marketing approval is sought, liraglutide had greater benefits against type 2 diabetes, the kind that generally develops in the adult years, than a now-standard medication, glimepiride, said a report in the Sept. 25 online issue of The Lancet.

Results of this trial and others have been given to the FDA, which will review them and decide whether to approve the drug for use in the United States, said trial leader Dr. Alan Garber, a professor of medicine, biochemistry and cell and molecular biology at Baylor College of Medicine, in Houston.

“It should be out sometime in the first half of next year,” Garber said.

Like the other GLP-1 versions, liraglutide has all the advantages of the natural molecule, with longer-lasting activity, said Dr. Sten Madsbad, a professor of endocrinology at the University of Copenhagen in Denmark, who wrote an accompanying editorial.

“First it stimulates insulin production,” Madsbad said. “Then it also promotes glucagon release from the pancreas. It also changes appetite, and therefore you eat less.”

Glucagon is a hormone that helps manages blood levels of sugar.

The trial was sponsored by the pharmaceutical company Novo Nordisk, which hopes to market the drug. If approved, liraglutide would be the second GLP-1 diabetes medicine on the U.S. market. The first is exenatide (Byetta), which was approved by the FDA in 2005. It is marketed by Amylin Pharmaceuticals and Eli Lilly. It is taken by injection twice a day, while liraglutide requires only one daily injection.

Exenatide is actually the form of GLP-1 found in the saliva of the gila monster, explained Dr. John Buse, president for medicine and science at the American Diabetes Association and a professor of medicine at the University of North Carolina. A new formulation of exenatide allowing once-a-week injection has successfully been tested, Buse added.

“There has been a lot of enthusiasm about exenatide based on reports of weight loss,” Buse said.

In a head-to-head test, liraglutide was more effective in controlling diabetes, Garber said. The newly reported study, he said, “shows that in patients already taking doses of existing oral medications, they did better when they switched to liraglutide.”

Weight loss was also seen in the trial, which ran for one year. Participants taking liraglutide lost an average of 4.4 pounds, while those taking glimepiride gained an average of 2.2 pounds.

“We want more medications that have this type of profile,” Garber said. “It is very well-tolerated, has few side effects and can lead to weight loss. Most diabetes medications now produce weight gain, and that is very discouraging to our patients.”

One shadow is a possible risk of pancreatitis, a condition which was reported in two people in the liraglutide trial and whose symptoms include nausea, vomiting and belly pain.

But Garber maintained that “there is unlikely to be a major pancreatitis concern, because it is so rare.”

A contest may develop between liraglutide and a once-a-week formulation of exenatide, Buse said. The longer-lasting exenatide version is expected to reach the U.S. market in about a year. It requires a standard hypodermic needle for injection, while liraglutide can be given through a small, ultrafine needle.

Several other GLP-1 drugs are in trials now and might be approved before long, Buse said. “It will be a great opportunity for patients to have so many choices,” he added.

By Andrew Stern Thursday, Apr. 10, 2008; 4:26 AM

CHICAGO (Reuters) – Aggressive use of drugs to lower cholesterol and blood pressure helped reverse heart disease in people with diabetes, U.S. researchers said on Tuesday.

The 3-year study of 499 Native American adults with type 2 diabetes showed that lowering blood pressure and cholesterol more than is usually recommended helped reverse thickening of the arteries and damage to the heart.

This is good news for everyone with diabetes, the researchers said — especially Native Americans, who have high rates of the disease.

“These patients are two to four times more likely than people without diabetes to die from heart disease,” said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.

“For the first time, we have evidence that aggressively lowering LDL cholesterol and blood pressure can actually reverse damage to the arteries in middle-aged adults with diabetes.”

But other experts said the study, published in the Journal of the American Medical Association, did not resolve the debate over how low to go.

Advocates of aggressive treatment with cholesterol-lowering statins and blood pressure drugs argue the lower, the better, though conclusive data to support that view is lacking, wrote Duke University’s Eric Peterson in a commentary.

“We know now that it’s important to control risk factors for heart disease in people with diabetes, yet we don’t know how far to aim,” said Barbara Howard, who conducted the U.S. government-funded study with colleagues at MedStar Research in Hyattsville, Maryland.

The group receiving standard care had targets of low density lipoprotein — “bad” LDL cholesterol — of 100 milligrams per deciliter or lower, and systolic blood pressure (the higher number when the heart contracts) of 130 or lower. Those treated more aggressively had targets of 70 milligrams of cholesterol and blood pressure level of 115 or lower.

Blood pressure and statin drugs were provided to patients by Merck and Co and Pfizer Inc.

Ultrasound measurements taken of the carotid artery in the patients’ necks — a reliable indicator of hardening or thickening of the arteries that is a precursor to heart disease — showed improvement in those treated aggressively with statins.

“We found that in the aggressive group there was actually a reduction in the thickness of the vessel in the neck as compared to the standard group whose neck vessels got a little bit worse … That has not been seen in most studies,” Howard said.

Measures of the heart’s main pumping chamber found enlargement at the beginning of the study — a sign of potential heart trouble — was reduced by the blood pressure drugs, and shrinkage was greater in the aggressive group.

Howard predicted the observed changes would lead to fewer heart attacks and strokes among aggressively treated patients.

The study did not last long enough to find such a difference, though patients will continue to be tracked and additional research may draw a firmer conclusion.

Diabetes kills an estimated 284,000 people in the United States each year, up to 65 percent of them from heart and artery disease, according to the NHLBI.