NewNowNext April, 2010

New insulins on the horizon are designed to be taken three times a week.

Novo Nordisk Makes Ground on the Next Generation of Insulins

We’ve just heard that research at Novo Nordisk is moving quickly on two new insulins, one dubbed “degludec” and the other “degludec plus.” The first is a “next generation” basal insulin (a follow up to Levemir) that patients could take as infrequently as three times per week; the other is a fixed combination of a rapid-acting insulin and the new degludec insulin (a “next generation mix,” as it were).

Eight-thousand patients are now enrolled in clinical trials, and if all goes well, these new insulins will go to the FDA in early 2012. The trial programs are named BEGIN and BOOST, respectively. BEGIN will compare insulin degludec against Lantus in type 2 patients who have never been on insulin, as well as type 1 and type 2 patients on a basal/bolus regimen (known as MDI – multiple daily injections). BOOST will compare the next-generation insulin degludec plus to Levemir/rapid-acting insulin in patients on a basal/bolus regimen. In total, the trials will recruit 10,000 patients – the largest trial ever for a diabetes therapy! Clearly, Novo Nordisk is hoping to persuade some patients currently on Lantus to take one of its next-generation products – in 2009, more than three patients took Lantus for every one that took Levemir, all else equal.

The results for BEGIN and BOOST have yet to come out, but we will be looking for these in the next few months. Although it is difficult to know how much of a improvement these new insulins will have on glycemic control, glycemic variability, and hypoglycemia rates, the company’s head of Research and Development Mads Thompsen has suggested that early-stage studies for degludec show improvements over current insulin analogs that are on par with the improvements between insulin analogs and human insulins (30-35% reductions in hypoglycemia). He also pointed out the dosing flexibility of insulin degludec, noting that patients can give it to themselves in the morning or evening, with “no strings attached,” as well as the potential for three-times weekly dosing.

There are combination therapies on the horizon as well, such as a combination of insulin degludec and Victoza. Advantages of this combination, though much earlier stage, could include weight loss (or no weight gain) and less hypoglycemia than using insulin by itself. --ST

The JDRF moves forward internationally to advance the artificial pancreas.

JDRF Teams Up with the European Artificial Pancreas Consortium

The JDRF has partnered with a group of European academics and members of industry who are working together to advance the development of the artificial pancreas in Europe. The group, known as the European Artificial Pancreas Consortium, will pool together experts in device development, computer programming, and clinical study design/execution. Device experts will be concerned with advancing the accuracy of continuous glucose sensors and developing an advanced combined insulin pump/CGM device that will only require one invasive catheter. Computer engineers and mathematicians will work on improving the safety and efficacy of the algorithms (the computer programs that process glucose monitoring information and translate it into appropriate insulin dosing commands). Experts in clinical design and execution will work to design efficient and informative studies that will help researchers and regulatory bodies evaluate the efficacy and safety of the combined insulin pump/CGM artificial pancreas in comparison to conventional intensive insulin therapy available today. We have seen the JDRF form several new partnerships recently, dedicated to advancing the development of the artificial pancreas, both in the US and abroad. While a fully automated insulin delivery system is the ultimate goal, work in the next several years will probably yield a system in which the user still plays a decision-making role during the daytime. Although the user will have a role in insulin dosing, this system will likely feature extra tools such as exercise and meal announcements to help users dose insulin more easily. We’re very impressed by the researchers involved in this agreement in the EU and impressed that JDRF put forward this partnership so quickly – we look forward to watching what happens in the EU and we hope lobbying happens in the US so that those stateside don’t get left too far behind. -- JS

BodyMedia’s GoWear fit armband advances the traditional pedometer.

The BodyMedia Armband: The Next Generation of the Pedometer

Pedometers – sensors that are worn to count the amount of steps taken throughout the day – have long been used to help measure physical activity and motivate people to stay active. Unfortunately, the number of steps taken throughout the day does not necessarily correspond well with the amount of calories spent, and misses many forms of physical activity. A higher-tech option is the BodyMedia armband. This device, worn around the bicep, senses far more than just the up-and-down motion of a pedometer. Within a fairly small 1.6 oz package (2.2” wide, 2.4” wide, and 0.5” deep) the BodyMedia armband contains sensors that measure motion in all directions, temperature, heat flux (the amount of body heat being dissipated into the air) and the sweat content of the skin. Combining all these measurements, the BodyMedia armband calculates a fairly accurate account of total calories spent, with an average error of less than 10% from the real value. The data stored on the armband can be downloaded to a computer (easily – and on Mac and PC!) with a USB cable or to a wireless display. This information can be used for diet adjustment and to record progress in an exercise regimen. BodyMedia also provides software called the BodyMedia FIT Activity Manager, which can track calorie expenditure, calorie intake (by inputting what you’ve eaten), and even sleep duration and efficiency. For more information on this tool, visit http://www.bodymedia.com. --NW

Academy Award winner Olympia Dukakis and her husband Louis Zorich are campaigning to increase diabetes awareness.

Ask.Screen.Know Promotes Free Medicare Diabetes Screening

While 18 million people are currently diagnosed with diabetes in the US, roughly six million more are estimated to have diabetes that has not been diagnosed. Gone unchecked, these people’s diabetes can quickly progress into diabetic complications like kidney or eye disease. Academy Award winner Olympia Dukakis and her husband, Louis Zorich, went for their free Medicare diabetes screening, and found out that Louis had diabetes. Since then, the two have been working to increase awareness and promote the use of Medicare’s free diabetes screening for people aged 65 and older. Their website, http://www.askscreenknow.com, provides information about the importance of being screening and what the results mean for you. If you know somebody that you think should take advantage of the free Medicare diabetes test, you can send them an email through the site that details Olympia and Louis’ experience and explains how they can get tested. --NW

Agamatrix, makers of the WaveSense brand of blood glucose meters, recently penned a deal with insulin manufacturer sanofi-aventis.

Sanofi-Aventis Partners with AgaMatrix on Diabetes Technology Front

Sanofi-aventis, makers of Lantus long-acting insulin and Apidra rapid-acting insulin, has teamed up with AgaMatrix, which manufacturers the WaveSense brand of blood glucose meters (KeyNote, Presto, and Jazz). AgaMatrix will continue to market WaveSense meters, but additionally the two companies will work together to design new products for diabetes management. The companies have not yet disclosed the nature of their joint products; we assume many of the ideas relate to having a blood glucose monitor around to better dose insulin. Or, perhaps a joint insulin pen and blood glucose monitor could somehow be built. This would mean one less piece of equipment for pen users to carry around, something any insulin user would surely appreciate. Management at sanofi-aventis said in a recent report that they expected the first blood glucose meter(s) jointly developed with AgaMatrix to be available sometime between July and December of 2010. Notably, they said the product(s) would specifically help patients in the dosing of Lantus. --NW