Glipizide/Metformin HCl is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. It is also indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. Our generic Glipizide/Metformin HCl is the bioequivalent to Metaglip(R), a registered trademark of Bristol-Myers Squibb Company. According to IMS Data, for the twelve months ended September 2007, Glipizide/Metformin HCl generic and brand products (Metaglip(R)) combined had annual sales of approximately $25 million.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain this approval from the FDA. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

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Researchers now believe that high levels of alpha lipoic acid can be particularly useful in preventing this process, by inhibiting the formation of the adhesion molecules. It can also lower triglycerides, another important risk factor for cardiovascular disease. It may also function as an antioxidant, and helps to normalize insulin signaling and glucose metabolism.

From what we understand, this supplement would be most valuable as a preventive mechanism before people have advanced cardiovascular disease, Frei said. However, it may help retard the process at any stage, and may also be of value in treating diabetic complications.

Also of considerable interest, Frei said, is the apparent role of lipoic acid supplementation in reducing weight gain. It appears to have this effect both through appetite suppression, an enhanced metabolic rate, and “ at least in laboratory animals “ has been shown to stimulate higher levels of physical activity, which again would increase caloric expenditure and further reduce weight.

Mice given lipoic acid supplements simply chose to eat less than a control group that did not receive supplements, suggesting a reduced appetite. In another test, mice that received supplements gained less weight than other mice in a control group that were given identical amounts to eat, suggesting a higher metabolic rate and enhanced activity levels.

Weight gain and obesity is a major risk factor for atherosclerosis and heart disease, and lower weight and abdominal fat may be one of the mechanisms by which lipoic acid has beneficial effects, Frei said. The study concluded that lipoic acid supplementation may be a promising approach to prevent weight gain and to lower cardiovascular disease risk in humans.

Although some of the most compelling research with lipoic acid research has been done in mouse models, scientists say, there should be a reasonable extrapolation to humans, because the lipoprotein profile is similar, as well as the composition of the atherosclerotic lesions. These mouse models are routinely used in studies of human atherosclerosis.

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