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dina1957
Thu, Apr-12-07, 13:59
I while ago we had a discussion on elevated cortisol leading to T2 diabetes. I always believed that continuous stress wrecks havos in our endocrine system, so this article suggesting that elevated cotrisol alone can cause T2 without crappy diet, and helps control BGs if in fact, the cortisol is a culprit.


Just interesting to see what the possible side effects, cortisol in excess is bad news, but we can't live without it. Overall, looks promissing.


A Novel Cortisol Synthesis Inhibitor For Type 2 Diabetes

Results from a Phase 2A study showed that the data lends support to the concept that abnormalities in cortisol activity may play an important role in the causation of type 2 diabetes and metabolic syndrome, a cluster of co-morbidities commonly associated with type 2 diabetes and insulin resistance.

DiObex, Inc., a privately- held biopharmaceutical company focused on the development of therapeutics to treat metabolic diseases, announced positive phase 2a results for DIO- 902, a novel Cortisol Synthesis Inhibitor.

In a recently completed multi-center, randomized, placebo-controlled trial, patients with type 2 diabetes were treated for two weeks to evaluate the safety, pharmacokinetics and activity of three dose levels of DIO-902. After two weeks of treatment, patients at all dose levels of DIO-902 showed significant reductions in total and LDL-cholesterol as well as trends toward an improvement in glycemic control as measured by HbA1c, fructosamine and fasting blood glucose. Mean levels of C-reactive protein, an inflammatory marker, were also significantly reduced. In contrast, metabolic control in patients in the placebo group remained stable or deteriorated slightly. These data lend support to the concept that abnormalities in cortisol activity may play an important role in the causation of type 2 diabetes and metabolic syndrome, a cluster of co-morbidities commonly associated with type 2 diabetes and insulin resistance. In the growing number of patients with type 2 diabetes and metabolic syndrome, co-morbidities such as hypertension and abnormal lipoprotein levels dramatically increase the risk of cardiovascular disease.

DIO-902 inhibits synthesis of the stress hormone cortisol. Data from various
epidemiological and clinical studies have suggested that a link exists between high cortisol levels and adiposity, insulin resistance, and hyperglycemia—some of the common elements of the metabolic syndrome and type 2 diabetes. The two-week trial with DIO-902 included patients with type 2 diabetes who were randomized to placebo or three different doses of the drug. Patients who received DIO-902 had drops in total and LDL cholesterol as well as modest drops in A1c from fairly low mean baselines values, generally between 7% and 9%.

"We are delighted with the preliminary data that we have generated to date, and at the prospect of taking the leading Cortisol Synthesis Inhibitor to the next level of clinical development. DIO-902 is clearly at the head of the pack in the advancement of this exciting new drug category," commented Daniel Green, DiObex President.

"DIO-902 offers the possibility of adding a new therapy to the armamentarium which may have an impact on the underlying cause of type 2 diabetes. The prospect of significantly reducing multiple cardiac risk factors with a single drug is an extremely attractive opportunity to enhance patient compliance and convenience while reducing the need for polypharmacy," said Bernice Welles, M.D., Vice President of Development at DiObex.

Daniel Green, President of DiObex, stated that he expects if everything goes well, the drug could enter phase 3 by early 2009 looking at partnering options. It will start enrolling patients in a 16-week phase 2b dose-ranging study in mid-2007. While this is early work, we think DIO-902 could potentially be a good combo drug because of its novel mechanism.

In other great news for DiObex, the company will have two abstracts presented at ADA - Dr. Steve Edelman will be presenting an abstract on DIO-901 and Dr. Sherwyn Schwartz will be presenting an abstract on DIO-902.

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(http://www.diabetesincontrol.com/rebuilder/index.php) This article came from
http://www.diabetesincontrol.com/results.php?storyarticle=4704 (http://www.diabetesincontrol.com/results.php?storyarticle=4704)


(http://www.diabetesincontrol.com/results.php?storyarticle=4704)