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Depomed Data Published in Diabetes Care on Glumetza, an FDA-Approved Treatment for Type II Diabetes.


MENLO PARK, Calif. -- Depomed, Inc. (Nasdaq:DEPO DEPO Delegated Episcopal Pastoral Oversight
DEPO Devils Postpile National Monument (US National Park Service)
DEPO Defence Export Promotion Organization (Pakistan)
DEPO Double Even Pass Odd
) announced today that the results of its Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  with Glumetza(TM), an FDA-approved, once-daily version of metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus.

met·for·min
n.
 for the treatment of Type II diabetes Type II diabetes
Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise.

Mentioned in: Diabetic Ketoacidosis
, were published in the April 2006 issue of Diabetes Care. The data demonstrated that Glumetza (extended-release metformin) controlled glucose levels in all key glycemic Glycemic
The presence of glucose in the blood.

Mentioned in: Cholesterol, High


glycemic

pertaining to the level of glucose in the blood.
 measures at least as effectively as immediate-release metformin and demonstrated excellent tolerability. Importantly, the data showed the most effective glycemic control was achieved with the once-daily 2,000 mg dose of Glumetza.

"Metformin is a commonly prescribed first-line treatment for patients with Type II diabetes, with over 42 million prescriptions written in 2005 that generated $1.4 billion in sales," said Bret Berner, Ph.D., vice president, Product Development and chief scientific officer of Depomed. "We feel that Glumetza provides a unique formulation of metformin that increases the potential of what this drug can offer. Glumetza leverages Depomed's AcuForm(TM) drug delivery technology, which is designed to enhance tolerability and reduce the gastrointestinal side effects Side effects

Effects of a proposed project on other parts of the firm.
 associated with oral medications."

The paper, entitled "Efficacy, Tolerability, and Safety of a Novel Once-Daily Extended-Release Metformin in Patients with Type 2 Diabetes type 2 diabetes
n.
See diabetes mellitus.
" (Sherwyn Schwartz, M.D., et al), summarized the data gathered during a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind Phase III clinical trial comparing treatment with Glumetza to immediate-release metformin in patients with Type II diabetes. Patients were randomized to receive one of four treatment options: Glumetza 1,500 mg once daily, Glumetza 1,500 mg twice daily, Glumetza 2,000 mg once daily, or immediate-release metformin 1,500 mg twice daily. All four patient groups demonstrated significant reductions in HbA1C, a common measure of glucose levels (p less than 0.001). There were no significant differences in efficacy among the four groups, although fewer patients discontinued treatment due to lack of efficacy in the 2,000 mg Glumetza group than in the immediate-release metformin group (1.8% versus 8.0%, p=0.007).

"Most physicians want to see their patients achieve a 2,000 mg dose of metformin, with the minimal target dose of 1,500 mg," said Dr. Sherwyn Schwartz, endocrinologist, lead author on the paper, and a principal investigator in the Phase III clinical trials of Glumetza. "Side effects such as nausea and diarrhea are thought to be a primary reason that more than half of all patients don't achieve the target dose of metformin needed to control their blood glucose blood glucose Diabetology The principal sugar produced by the body from food–especially carbohydrates, but also from proteins and fats; glucose is the body's major source of energy, is transported to cells via the circulation and used by cells in the presence  and are no longer taking their medication as prescribed after the first year. Following this Phase III clinical trial, patients were switched to the 2,000 mg once-daily dose of Glumetza for 24 weeks, and we observed successful maintenance of blood glucose levels and a 97.2% rate of adherence to the therapeutic regimen as prescribed."

Glumetza is currently marketed in Canada by Biovail Corporation. Depomed is in negotiations with several companies regarding promotion rights in the U.S. and has licensed Korean commercialization rights to LG Life Sciences.

About Glumetza(TM)

Glumetza(TM) is a once-daily, extended-release formulation of metformin HCl metformin HCl
(metfor´min),
n brand name: Glucophage;
drug class: oral hypoglycemic, biguanide derivative;
action exact mechanism unknown, requires insulin secretion to function properly;
use: type II diabetes mellitus.
 indicated as an adjunct to diet and exercise to improve glycemic control in adult patients (18 years and older) with type 2 diabetes. Glumetza may be used concomitantly with a sulfonylurea sulfonylurea /sul·fo·nyl·urea/ (sul?fo-nil-u-re´ah) any of a class of compounds that exert hypoglycemic activity by stimulating the islet tissue to secrete insulin; used to control hyperglycemia in patients with type 2 diabetes mellitus  or insulin to improve glycemic control in adults.

Glumetza is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in females), congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  to metformin HCl, and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. As with all metformins, there is a warning regarding lactic acidosis with Glumetza. For additional information on the product, please access the package insert at http://www.depomedinc.com/Glumetza_Prescribing_Info.pdf.

About Diabetes

Diabetes affects an estimated 18 million Americans and is increasing by approximately one million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from Type II diabetes, the most common metabolic disease in the world and the fifth-deadliest disease in the U.S. Diabetes is the leading cause of blindness, end-stage renal disease End-stage renal disease (ESRD)
Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity.

Mentioned in: Chronic Kidney Failure

end-stage renal disease 
 and non-traumatic loss of limb and can also lead to heart disease, stroke, high blood pressure, kidney disease and other serious conditions. In the U.S., the public health cost of diabetes is more than $130 billion per year.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin(R) XR (ciprofloxacin hydrochloride) once daily, extended-release tablets have been approved by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 for the treatment of uncomplicated urinary tract infections. In addition, regulatory applications for once daily Glumetza(TM) for the treatment of Type II diabetes have been approved in the U.S. and Canada. The company completed a Phase II trial in postherpetic neuralgia with its product, Gabapentin GR. Additional information about Depomed may be found at its web site, www.depomedinc.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to those related to our commercialization efforts and those of our collaborative partners, our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 11, 2006
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