Get ready for a slew of diabetes news announcements, because the ADA's huge annual conference starts today!
I'll be on an airplane pretty much all day (Friday) heading out to Orlando to cover this conference live, although I must warn you: it's quite overwhelming. Running around the 450,000 square-foot convention center trying to see every diabetes company represented in the enormous exhibit halls while hundreds of symposia and other talk sessions are happening simultaneously is quite a lot for one lone blogger. Between all the talks and one-on-one briefings, I never know when to sit down and write. But I shall, as ever, do my best to bring you the news you can use ;)
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
Snail Uses Insulin to Poison Fish
New study shows these slow-moving creatures use toxic form of insulin to capture prey.
A New Square Patch Insulin Pump
Israeli company developing new reusable square insulin pump that has Bluetooth for smartphone communication.
I'm actually headed for a diabetes conference triple-whammy: first, the ADA, then the 2nd annual Roche Diabetes Social Media Summit on Tuesday, followed by the Children with Diabetes Friends for Life conference, which I am delighted to finally experience live! More on all of that soon.
But to get back to the reams of news announcements coming out around the ADA event:
* Today, the JDRF announced that Animas Corp. will be integrating its insulin delivery products into the working Artificial Pancreas model being developed by the University of California Santa Barbara (UCSB) and Sansum Diabetes Research Institute. According to Sansum's Director of Clinical Research and Diabetes Technology Dr. Howard Zisser: "This milestone should improve the communication performance of the system while also expanding the number of possible research centers that can use it to help close the loop for automated insulin delivery for patients with type 1 diabetes. The extended communications range will also allow research subjects greater freedom during clinical trials."
* Eli Lilly has announced an agreement to sell a low-cost insulin line in partnership with Walmart beginning in mid-September, under the dual-branded name Humulin(R) ReliOn(R). This includes 10 mL vials of Humulin(R) R U-100, Humulin(R) N, and Humulin(R) 70/30 formulations.
This, by many counts, is an indication of "how the economy impacts diabetes management" and the fact that cost measures will be a running theme this year (yay for us!).
* Debiotech and STM Electronics are bragging about a new "Jewel Pump" they'll be displaying at the conference. It's a not-yet-FDA-approved tiny disposable patch pump that uses the most advanced microfluidic MEMS (Micro-Electro-Mechanical Systems) technology in diabetes treatment. It is going to be smaller, thinner and lighter than any pump on the market, they claim (wow!)
* On the oral type 2 diabetes drug front:
Johnson & Johnson announced two deals — first, an agreement with Diamyd Medical, a Swedish company conducting late-stage clinical trials on a drug designed to halt destruction of pancreatic islet cells, to delay or prevent disease progression and complications (cool!) And second, a deal with Metabolex Inc. to develop some potential new T2 drugs now in the "preclinical stage."
Novo Nordisk announced that they are "reinitiating their Phase 3 obesity program for liraglutide." This means they're testing the new drug Victoza as a treatment that could be prescribed to treat obesity, even if the patient doesn't have diabetes.
Astra Zeneca & Bristol Myers Squibb unveiled some new data on their drug Dapagliflozin, tested on newly diagnosed T2 patients. According to a study published in Diabetes Care: "The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for type 2 diabetes."
* A company called "Healthy Interactions" is celebrating the fact that it has now trained 20,000 diabetes educators on its "Conversation Map" tools, that allow patients to discuss D-management tasks and obstacles in a group setting. Very useful stuff! (although as far as I know, there are only about 15,000 CDEs in the whole country...?)
* Sensor-augmented pump therapy versus multiple daily injections (MDI): results of the STAR 3 study, a one-year randomized controlled trial (funded by Medtronic) that compares the efficacy of these two treatment methods, will be presented Dr. Richard Bergenstal, the President, Medicine & Science of the ADA.
* Heart health controversy: A heated debate will take place over the need for a pre-approval cardiovascular risk requirement for new diabetes drugs. Participants are former director of the FDA's Division of Metabolism and Endocrinology Products, Dr. David Orloff, and Dr. Steven Nissen, the Cleveland Clinic cardiologist who stirred the Avandia (GSK's rosiglitazone) controversy in 2007.
Look for many more headlines on the oral drug front, including news about:
- SGLT2 inhibitors — "the next major class of oral agents to enter the market"
- GLP-1 therapies, including Roche's taspoglutide, GSK's albiglutide (Syncria), Amylin/Lilly/Alkermes' Bydureon (EQW), and Novo Nordisk's Victoza (liraglutide)
- "Next-generation insulins... that have the potential to transform insulin therapy" - longer-acting basal insulins, short-acting bolus insulins, oral formulations, and combinations with GLP-1 drugs
- More new "novel oral agents" with crazy-complex names such as: IL-1 beta antibodies (XOMA's XOMA 052), glucokinase activators (Array BioPharma/Amgen's ARRY-403/AMG-151, Roche's Piragliatin, OSI Pharmaceutical's PSN010), selective PPAR gamma modulators (InteKrin's INT-131, Genfit's GFT505), PTP-1B inhibitors (ISIS's ISIS 113715), GPR119 agonists (OSI's PSN821), and various PPAR agonists (Roche's aleglitazar, Ono's ONO-5129, sanofi-aventis' AVE0897, Plexxikon's indeglitazar, Dara Biosciences' DB900)
* Again, cost-effectiveness will be key. According to David Kliff of Diabetic Investor: "We are headed for a system where cost-effectiveness will figure into the drug approval process... The simple fact is there are too many me-too drugs on the market and we don't need multiple drugs in the same category that do exactly the same thing."
* A ton of attention to continuous glucose monitoring (CGM) as it "moves into the mainstream." Along with updates on the closed loop/ Artificial Pancreas project. The ADA and JDRF are co-hosting a symposium on this ("Are We Closer To Closing the Loop?") that looks to be pretty exciting. There will be Q&A for 45 minutes! "Unheard-of for ADA," writes Kelly Close.
Phew! Keep your eyes peeled for all this and more next week.