Inexpensive TB Vaccine could be a Revolutionary Diabetes Drug

June 28th, 2011

An inexpensive vaccine that's been used for over 90 years to combat tuberculosis may have the ability to reverse type 1 diabetes. Although the early results were met with skepticism, seven studies in mice over the last ten years have established that the generic drug BCG (bacillus Calmette-Guerin) can prevent immune system T cells from destroying insulin-producing cells, allowing the pancreas to regenerate and once again produce insulin.

A research team from the Massachusetts General Hospital Immunobiology Laboratory led by Dr. Denise Faustman, PhD, successfully reproduced the results in a small group of human subjects, using very small doses of the vaccine. Those diabetics receiving the vaccine, all of whom had been Type 1 for an average 15 years, showed both a decrease in pancreas cell-destroying T cells, and an increase in the insulin precursor C-peptide - an indicator of insulin production.

The results were temporary, and it is likely that the vaccination would have to be repeated on a regular basis. The team believed using higher doses would have led to a more positive effect, but trial dosages were limited by the FDA. They are now negotiating with the FDA to use higher concentrations in a larger trial.

Type 1 diabetes is an auto-immune condition in which the body attacks its own insulin-producing beta cells in the pancreas. The body needs insulin to fuel itself and regulate blood sugar, so type 1 diabetics must take daily insulin injections to manage their blood sugar levels.

BCG works by increasing the levels of an immune system protein called tumor necrosis factor, or TNF. High levels of TNF block other parts of the immune system from attacking the body, especially the pancreas. This is a major shift in direction in diabetes treatment, as it was not previously believed possible to restore pancreas function in insulin dependent diabetics.

Doctors and researchers are surprised and excited at the unanticipated prospect of controlling the immune system to restore the body' ability to produce normal insulin levels. "If this is reproducible and correct, it could be a phenomenal finding," enthuses Dr. Robert Henry of the University of California, San Diego.

The research was largely funded by the Iacocca Foundation, founded in 1984 by auto manufacturer magnate Lee Iacocca and his daughters after his wife died from diabetes complications at age 57. The Foundation has committed to continued financial assistance for phase II clinical testing of the potentially revolutionary diabetes medication.

Diabetes Drug Metformin Safer for the Heart

July 12th, 2011

The type 2 diabetes drug metformin is safer for the heart than other older diabetes medication, according to a two-year study. The findings are important because older patients with diabetes are at particular risk for cardiovascular disease, and because many of them are prescribed a class of diabetes medications called sulfonylureas that may raise this risk.

The controversial diabetes drug Avandia, which has been linked to heart problems, is a sulfonylureas diabetes drug. Sulfonylureas have also been linked to episodes of low blood sugar, and to weight gain.

Sulfonylureas drugs and metformin (also known by the brand name Glucophage) lower blood sugar in different ways. Metformin works by suppressing sugar production in the liver, while sulfonylureas work by increasing insulin production. To read more about the study findings on WebMD, >CLICK HERE.<

Diabetes Drug Metformin Combined with Exercise Has Surprise Effect on Glucose Control

August 22nd, 2011

It's common enough for researchers to look at the impacts of prescribed drugs on the body. And if you're a diabetes researcher who believes that exercise has great benefits for those with type 2 diabetes, you're hoping your research will show that. But when Normand Boulé looked at the dual impacts of exercise and metformin - two of the most commonly-prescribed modalities for glucose control -the hoped-for double whammy wasn't the result.

Researchers looking at the effects of the oral diabetes medication metformin and exercise in Type 2 diabetes patients found that a combination of these modalities didn't lower glucose control as much as hoped. Surprisingly, study participants showed better glucose control when sedentary. Researchers think that because prescription metformin and exercise both act to lower glucose levels, the combination may have triggered a counter regulatory response by the body to prevent glucose levels dipping too much.

Read the full article on ScienceDaily-

Mysterious Fetal Tissue Helps Grow Insulin Producing Beta Cells

September 7th, 2011

A somewhat mysterious soft tissue found in the fetus during early development in the womb plays a pivotal role in the formation of mature beta cells, the sole source of the body's insulin. This discovery, made by scientists at University of California, San Francisco (UCSF) and Texas A&M University, may lead to new ways of addressing Type 1 and Type 2 diabetes.

As reported in the journal PLoS Biology, during the late stages of development in mice, this fetal tissue -- called the mesenchyme -- secretes chemicals. Those chemicals enable insulin-producing beta cells to mature and expand. Remove this mesenchyme tissue, the researchers found, and the mice do not grow their full complement of beta cells.

This work provides researchers with an immediate tool for research and diabetes drug discovery. By identifying the chemicals that this tissue secretes, scientists may be able to create new beta cells in the body or in the test tube - something currently beyond the reach of medical science that could potentially eliminate the need for insulin injections.

To read the full article on ScienceDaily, >CLICK HERE.<

Diabetes Drug Byetta Approved as Add-On to Long Acting Insulin

October 20th, 2011

The US.Food and Drug Administration has approved a new use for Amylin Pharmaceuticals Inc. and Eli Lilly's BYETTA injection. BYETTA is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD). It should be used in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

"This expanded use for BYETTA is important for clinical care, in that it provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill.

"BYETTA is well-suited for use with insulin glargine, offering a simple fixed-dose regimen that can help improve control of blood sugar overall and after meals. In a clinical trial, patients using BYETTA with insulin glargine achieved better glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using insulin glargine alone."

BYETTA is not insulin and should not be taken instead of insulin. The diabetes medication should not be taken with short- and/or rapid-acting insulin. BYETTA should not be taken by type 1 diabetics, people with diabetic ketoacidosis or patients with a history of pancreatitis.

In the study supporting the expanded use, patients receiving insulin glargine, with or without metformin and/or a TZD, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin glargine alone (p<0.001). A1C is a measure of average blood sugar over three months.

Nausea, which was the most common adverse event, occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin glargine alone.

BYETTA is an injectable diabetes medication that exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes, and is now the first and only GLP-1 receptor agonist approved for use in the U.S. as an adjunct to long-acting insulin glargine (Lantus), with or without certain oral agents.

The double-blind clinical trial evaluating BYETTA as an add-on therapy to insulin glargine was published in Annals of Internal Medicine.(i) In the study, 261 patients receiving insulin glargine with or without metformin and/or a TZD were randomized to receive BYETTA 10 micrograms or placebo. Patients who may have been at increased risk of hypoglycemia (A1C?8 percent) reduced their dose of insulin glargine by 20 percent.

Five weeks after randomization, all patients had insulin doses aggressively titrated to target fasting blood glucose. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.

After 30 weeks of treatment, the proportion of participants achieving the target A1C?7 percent was 60 percent in the BYETTA group and 35 percent in the insulin glargine group (p<0.001). For the target A1C?6.5 percent, the proportions were 40 percent and 12 percent, respectively (p<0.001). Both groups showed lower fasting plasma glucose concentrations; however, after morning and evening meals, when BYETTA was administered, postprandial glucose control was significantly improved in patients treated with BYETTA, compared to placebo.

On average, weight decreased by 4 pounds in patients adding BYETTA, compared with an increase of 2 pounds in patients treated with insulin glargine alone (p<0.001). The greater improvement in A1C with BYETTA was not accompanied by an increase in hypoglycemia, compared to insulin glargine alone.