Thiazolidinediones are adjunctive therapies for diabetes mellitus (type 2) and related diseases.
A new understanding of insulin resistance and the action of diabetes drugs such as Avandia and Actos could pave the way for improved medications that are more selective and safer, say scientists from Dana-Farber Cancer Institute and The Scripps Research Institute.Our findings strongly suggest that good and bad effects of these drugs can be separated by designing second-generation drugs that focus on the newly uncovered mechanism, said Bruce Spiegelman, PhD, of Dana-Farber, senior author on a report appearing in the July 22 issue of Nature.
After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes.
The diabetes drug rosiglitazone has been under intense scrutiny since a 2007 study in the New England Journal of Medicine looked at more than 40 clinical trials and linked the drug's use with increased risk of heart attack and death from heart disease.
Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).
A new study published online today by JAMA shows that among patients age 65 years and older, rosiglitazone (a medication for treating Type 2 diabetes) is associated with an increased risk of stroke, heart failure, and all-cause mortality (death) when compared with pioglitazone (another medication for diabetes). The study was published online today in advance of an upcoming Food and Drug Administration meeting that will review the safety of rosiglitazone. The paper will appear in the July 28 print issue of JAMA.
New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.
ChemoCentryx, Inc., today announced that it has undertaken a Phase II clinical trial of CCX140, a novel, orally-available small molecule compound designed to specifically target the chemokine receptor known as CCR2.
Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.
Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial, a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.
The data are inconclusive on heart risks from a class of blood sugar-lowering drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or rosiglitazone (Avandia), but the medications should be used with close monitoring from healthcare providers according to a joint science advisory from the American College of Cardiology and the American Heart Association.
Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.
Research: Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: Retrospective cohort study using UK general practice research database
A new, first-of-its-kind diabetes algorithm created to help achieve glycemic (blood sugar) control in type 2 patients was published online today in the September/October edition of Endocrine Practice.
Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.
Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients.
Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.
Rosiglitazone, a drug used to treat type 2 diabetes, is associated with an increased risk of heart failure and death among older patients compared to a similar drug (pioglitazone), concludes a study published on bmj.com today.
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).
Translational Genomics Research Institute (TGen) scientists have identified five genetic biomarkers that could help lead to improved treatments, with fewer side-effects, for patients with diabetes.