new now next
On December 14, the FDA granted 510(k) clearance for Insulet’s next-generation, much smaller OmniPod insulin patch pump, concluding a lengthy 19-month US regulatory review process. Insulet expects to begin shipping the new pump to patients in early 2013. As we’ve been reporting, the new OmniPod is an impressive 34% smaller, 25% lighter, and 16% slimmer than its first-generation predecessor, yet it retains the 200-unit insulin reservoir and no tubing. We’ve seen it in person and can attest to the noticeable improvement in size over the current OmniPod.
The design of the second-generation pod has some new“human factor screens”, which we’re looking forward to seeing. Notably, the new OmniPod features improvements in both correction and meal boluses to calculate insulin on board (the current pod only accounts for meal boluses) – we know many diabetes educators and doctors who will be very excited about this. We’re also psyched to see that the new OmniPod features a greater wireless communication range between the pod and the updated handheld Personal Diabetes Manager (PDM) (up to approximately eight feet, compared to two feet in the current pod), The new OmniPod was officially launched at the EASD conference in Berlin, Germany, in October – patient feedback that we’ve heard has been excellent thus far and we look forward to writing a test drive in diaTribe #51 - we’re very eager to get our hands on one as we really think this product will make many more patients want to try pumping.
How do you get the new system? This will depend on your particular circumstances:
- Current in-warranty OmniPod users: Current OmniPod users will be upgraded to the new smaller pods and updated PDM handheld at no cost – sincere kudos to Insulet for making the improved product available at no extra cost to patients (this rarely happens with diabetes therapy on the drug front – we hope they take note). Once the new pod launches in early 2013, current users will be upgraded when they reorder supplies. As we understand it, Insulet plans to upgrade all current users by the end of the third quarter of 2013.
- OmniPod users currently out of warranty, patients with a competitor pump that is more than four years old, and non-pumpers: The new OmniPod will have the same price as the original, which is approximately $600 for the starter kit. For individuals who are not on an insulin pump or have had their current pump for more than four years, much of this cost is typically covered by insurance. While insurance may vary greatly, the average new OmniPod user pays approximately $100 out of pocket for an OmniPod starter kit. Those interested should contact Insulet directly or visit this page to receive their specific benefits information.
- Patients with a competitor pump that is less than four years old: Patients who obtained their current pump within the last four years can still switch to the OmniPod through Insulet’s “Cut the Cord” program for $199.
Insulet has announced that it will contact all current users by phone or email to inform them when it is time to upgrade – we’re sure many patients will be calling them as well. The company has also put together a page at http://www.myomnipod.com/NewOmniPod/ as an ongoing resource for updates on the coming launch. –AW/AB/KC
On January 8, JDRF and Tandem Diabetes Care announced a partnership to develop a new dual-chambered pump, which would enable delivery of insulin plus another hormone (e.g., glucagon to prevent hypoglycemia) using the same device. JDRF has agreed to support funding for the development, testing, and manufacturing of Tandem’s dual-chambered pump for the next two years. This is very encouraging news, since many researchers believe that insulin-only control with an artificial pancreas does not go far enough.
As a reminder, the pancreas in someone without diabetes secretes several hormones in addition to insulin. The goal of this JDRF-Tandem partnership would be to produce a pump that can deliver two types of hormonal therapies, enabling better, more physiologic regulation of blood glucose levels. This was a point of emphasis during the recent Diabetes Technology Meeting (DTM) in November (see conference pearls in diaTribe #50), where we heard enthusiasm for bihormonal control with insulin and glucagon (particularly from Dr. Ed Damiano).
As we understand it, the Tandem pump would have separate reservoirs for the different hormones, though we’re not quite sure how the infusion sets would work. We assume separate tubing and potentially separate infusion sites would be needed, though we suspect more details will be announced in the coming years. Aside from a two chambered pump, another key area needed for innovation is glucagon – since current formulations of glucagon require mixing a liquid and powder prior to use, they are not optimal for use in a pump. However, encouraging news on this front came at DTM in November from Dr. Steve Prestrelski of Xeris Pharmaceuticals. Xeris is working on a stable formulation of glucagon that would not need to be mixed prior to use. Trials are beginning soon, and if all goes well, the timeline of Xeris’ glucagon could line up well with Tandem’s new pump.
As a reminder, Tandem Diabetes Care manufactures the t:slim insulin pump (see test drive in diaTribe #47). The pump was cleared by the FDA at the end of 2011 and was launched at the end of August 2012. Tandem’s innovative and patient-centric approach helped them create a pump that is intuitive and simple to use, including a color touch screen and many safety features. The combination of Tandem’s creative approach to building products and JDRF’s incredibly impressive and influential work on the artificial pancreas (see new now next in diaTribe #40 and new now next in diaTribe #44) should hopefully translate into an excellent product for patients.
In addition to a dual-chambered pump, Tandem is already partnered with Dexcom to integrate CGM into an insulin pump. As of the most recent update we just heard at the JP Morgan Healthcare Conference, a Tandem pump with a Dexcom CGM receiver built in could come as soon as 2014. We’re glad to see Tandem putting in place the necessary tools to build an artificial pancreas, and we look forward to seeing the progress on both these fronts in the coming years. –MN/AB
On November 14, the European Commission approved AstraZeneca and Bristol-Myers Squibb’s Forxiga (dapagliflozin) for type 2 diabetes throughout the European Union. Forxiga is an SGLT-2 inhibitor, the first drug of its type to be approved for use anywhere in the world. Like other SGLT-2 inhibitors, Forxiga works by allowing excess glucose to escape the body through urine (see learning curve in diaTribe #24). The drug works in a glucose-dependent way, meaning more glucose will be excreted when blood sugar levels are higher. In trials, patients using dapagliflozin typically reduced their A1c by an average of 0.8% to 1% in trials lasting a year (this is from a starting A1c of 8.5% before the trial began). Urination of excess glucose also means losing some excess calories each day, and indeed, participants in clinical trials lost a few pounds on average and saw a small drop in blood pressure.
Forxiga is a once-daily pill and can be taken either alone or in conjunction with other type 2 diabetes medications. We are particularly excited about the combination of SGLT-2 inhibitors with other diabetes medications in a single pill (fixed-dose combinations), which may occur in the future – examples include metformin and DPP-4 inhibitors (e.g., Januvia, Onglyza, and Tradjenta). Research suggests that the addition of an SGLT-2 inhibitor could potentially benefit patients on any kind of pre-existing treatment since its the way it works is distinct from that of other medications. AstraZeneca and BMS have yet to announce specifics regarding Forxiga’s cost, launch timeline, or reimbursement options in Europe.
Forxiga’s most common side effect is urinary and genital tract infections, which should be relatively easy to treat should they occur. Regulatory agencies have also raised some concerns regarding a potential increased risk of bladder and breast cancer and potential damage to the liver. These concerns ultimately led the FDA to deny dapagliflozin approval in the United States in January of this year (see new now next in diaTribe #39), although AstraZeneca and BMS have resubmitted dapagliflozin to the FDA with a new decision expected in mid-2013. The European Commission has also acknowledged these potential safety risks, but they judged that the potential benefits of Forxiga outweighed the risks and so recommended these concerns be assessed in post-approval clinical trials.
The new year could see the approval of multiple new SGLT-2 inhibitors in both the United States and Europe. J&J has submitted Invokana (canagliflozin) to regulators in both regions with an eye toward approval in 2013. The FDA will hold an advisory committee meeting on January 10 to discuss Invokana (we’ll be there!), and a decision from the Agency is expected this coming March. Pfizer’s ertugliflozin and Eli Lilly and Boehringer Ingelheim’s empagliflozin are two other SGLT-2 inhibitors that are currently in phase 3 trials, although it’s not clear when the companies expect to submit these for approval. Lexicon also has an SGLT-1/SGLT-2 dual-inhibitor that will begin phase 3 studies in early 2013; this drug works by a slightly different mechanism that prevents some glucose from being absorbed from the intestines in addition to allowing glucose to be excreted in the urine. We look forward to learning much more about the advantages and optimal use of this drug class as it comes to market in the coming years. –AW/JD
In December, Novo Nordisk announced that it will advance FIAsp, an ultra-rapid-acting version of Novolog (insulin aspart), directly into phase 3 trials in late 2013 (the last series of studies before a drug can be submitted to regulatory authorities; see the learning curve in diaTribe #16). The company expects the phase 3 program, called “Onset,” will include about 3,000 patients with type 1 or type 2 diabetes. The timing means that regulatory submission of FIAsp could occur around late 2014 or early 2015 at the earliest, meaning approval could come as soon as late 2015 or early 2016.
We view this announcement as exciting news, particularly since Novo Nordisk is the biggest insulin manufacturer globally, and we believe mealtime insulin is the insulin that has the most room for improvement. Compared to current fast-acting insulins (Novolog, Humalog, and Apidra), an ultra-rapid-acting insulin like FIAsp would have the biggest impact around mealtimes, since the speedier insulin action would better match the quick rise in blood sugar that follows meals (and better mimic the near immediate speed of insulin in people without diabetes). A faster insulin would also be more convenient than current rapid-acting insulins, which are recommended to be taken about 30 minutes before meals. Newer ultra-rapid-acting insulins could also be associated with less hypoglycemia (and thus, potentially less weight gain) – if the insulins can drop blood glucose more quickly, patients would be less likely to stack insulin and experience delayed hypoglycemia. Last, a faster-acting insulin would significantly improve efforts to develop an artificial pancreas, since closed-loop algorithms’ ability to control glucose tightly is limited by the slow speed of available rapid-acting analogs.
Novo Nordisk’s FIAsp is the ultra-rapid-acting insulin second closest to market, behind Mannkind's Afrezza (an ultra-rapid-acting inhaled mealtime insulin for people with type 1 and type 2 diabetes). MannKind plans to resubmit Afrezza to the FDA in the third quarter of 2013, meaning approval could come sometime in the first half of 2014 (Afrezza was previously denied FDA approval in January 2011). Biodel has several different ultra-rapid-acting insulins in development, and data from phase 1 and phase 2 studies are expected throughout 2013. As noted in conference pearls in diaTribe #44, Halozyme is also attempting to produce faster-acting insulin by adding an enzyme (PH20) that would temporarily degrade connective tissue in the skin, allowing insulin to be absorbed more quickly. One approach will test an injection of PH20 prior to inserting an insulin pump infusion set (“pre-administration”). Although PH20 is already FDA approved for use with other medications, Halozyme plans to conduct a large study in 2013 to confirm the early promising results the company has seen in insulin pumpers. It’s been great to see new progress on basal insulins, but especially for pumpers that only use rapid acting insulin, this will be an important move forward. Finally, the patents will expire in the next few years for current “rapid acting” insulins (Humalog, Novolog, Apidra), which means that those will also become more accessible for many more patients – very positive in our book, as they tend to work better for many patients than the traditional “regular” insulin, which is far less stable. We look forward to watching this field move forward. –AB
On November 28, CeQur announced that it had received CE Mark approval for its PaQ Insulin Delivery Device, allowing the product to be sold in Europe. The Swiss-based company has focused on bringing the PaQ device to the European market first, and it has not yet begun the process of securing FDA approval. No details have been shared on the product’s launch timeline, though clinical trial data will be presented at two meetings in 2013. PaQ is another simpler insulin delivery option designed for type 2 patients. Like Valeritas’ V-Go, CeQur is a wearable patch pump (no tubing) designed to provide basal-bolus insulin therapy for type 2 patients. As a reminder, the V-Go has been available here in the US since early 2012, and a recent user study suggests patients really like the device.
Insulin delivery for type 2 diabetes has long been an area of great need, since doctors have found it challenging to teach many type 2 patients how to take the optimal doses of insulin. Certainly, insulin pens represented great innovation, but particularly for patients needing multiple doses per day, it is great to see new options. Additionally, since many patients with type 2 diabetes do not require full-featured pumps (e.g., Medtronic’s Paradigm, Animas’ OneTouch Ping, Insulet’s OmniPod), and would also like more discretion, convenience, and simplicity than using pens and syringes. Products like the PaQ, V-Go, and J&J/Calibra Medical’s Finesse (bolus only) offer a nice middle ground between these two extremes. Indeed, these three pumps do not have screens, allow easy bolusing through clothing, and require no on-device customization or setup.
Besides their different geographic availability (V-Go currently in the US, PaQ eventually in Europe to start), there are some other key differences between the insulin delivery devices. Whereas the V-Go can be worn for 24 hours before it needs to be replaced (56, 66, or 76 unit reservoir), CeQur’s PaQ has a 330-unit reservoir that lasts up to three days. PaQ also allows for a wider range of basal rates than the V-Go, as users can select from seven preset basal rates (16, 20, 24, 32, 40, 50, or 60 units per day) vs. three for the V-G0 (20, 30, or 40 units per day). The key advantage of the V-Go is that it is purely mechanical and has no electronics, while the PaQ incorporates an electronic messenger that needs to be replaced periodically. As a result, the PaQ might be more expensive than the V-Go once it is launched, but there is limited information on pricing at present. –AW/AB
On November 29, NeuroMetrix announced that it had cleared the final hurdle holding up the introduction of the Sensus Pain Management System, designed for the treatment of chronic pain such as that caused by diabetic peripheral neuropathy (DPN). While the FDA cleared the Sensus device itself in August (see new now next in diaTribe #46), NeuroMetrix could not launch until the FDA granted 510(k) clearance for the disposable electrode that is used in tandem with the device. NeuroMetrix is now on track to launch Sensus in early 2013 – earlier in November, the company announced a distribution agreement with OneSource Medical Group, which focuses on Texas and Florida. Other such agreements will likely be forthcoming.
Sensus provides electrical stimulation to the skin using the newly approved electrodes, and this stimulation is designed to relieve the symptoms and better manage the chronic pain of diabetic peripheral neuropathy. DPN affects about half of all people with diabetes, and the extremely complex tangle of underlying causes for DPN means there’s no one treatment that is guaranteed to provide relief for all patients. Pfizer’s Lyrica, Eli Lilly’s Cymbalta, and J&J’s Nucynta ER are all used to manage the symptoms of DPN, and now Sensus has become the first device approved in the United States that is specifically designed to manage chronic pain in people with diabetes. According to NeuroMetrix, Sensus can be set up for use in less than a minute and can be worn underneath clothing for discrete pain relief. –AW
This month, in a surprise move, Vivus announced that its weight management medication Qsymia is now available via mail order through Walmart. This is an addition to the existing certified mail order pharmacy network of CVS, Walgreens, Express Scripts, and Kaiser Permanente (members only) as home delivery options for the medication. We’re encouraged to see that Walmart will participate in the Get Started Program as well, which offers a 14-day free trial of the lowest, starting dose of Qsymia (see new now next in diaTribe #49 for more information).
Vivus also recently announced that Qsymia is now covered as a standard benefit under the Express Scripts pharmacy benefit plan. This means that participating patients will now pay an estimated $50-$60 for their co-payment for a monthly prescription of Qsymia, approximately one-third of the retail price. Given Qsymia’s strong efficacy in late stage trials – patients lost 25 pounds on average! – these agreements should give more patients affordable access to the drug. Longer-term, we strongly believe more insurance companies and the government will begin paying for it. To learn more about Qsymia’s patient program, called “Q and Me”, which is available to anyone looking to lose weight (one doesn’t have to be on Qsymia to participate in this educational program), see www.qsymia.com. –AW/AB
On December 11, Omada Health launched Prevent (http://www.preventnow.com), an online version of the Diabetes Prevention Program (DPP). The landmark NIH-funded DPP study found that moderate weight loss (around 5% of body weight) and lifestyle changes could reduce the risk of developing type 2 diabetes by 58%. Participants in Omada Health’s 16-week Prevent program receive one-on-one support from a professional health coach via phone and messaging, as well as online courses to guide them through the DPP curriculum. To see how it works, click here.
Most notably, Prevent uses social networking to bring together similar participants, who are matched together based on their age, BMI, and location. These small groups then support each other as they follow Prevent’s four-phase program, which entails changing participants’ food habits; increasing their activity and exercise levels; preparing to face the challenges that might otherwise cause participants to fall back into unhealthy habits; and then sustaining their new, healthier choices long-term. Prevent also incorporates health data tracking using a pedometer and a cellular-connected wireless scale, which participants receive in the mail when they sign up. A recent pilot study of 230 people found that Prevent participants lost an average of 14 pounds, or 6.4% of their body weight, and 72% of participants remained in the program for the full 16 weeks, which is a very strong retention rate for a this type of program.
Prevent currently costs $120 per month for the four-month course ($480 total). This price is for individual consumers, and Omada Health is also working on a commercial version that will be offered through employers. Omada is also in talks with insurers and health systems to secure reimbursement for the program – we believe this is a question of “when,” not “if.” For comparison, Retrofit costs $259-$359 per month, the weight management drug Qsymia costs $135-$185 per month without reimbursement, and the original DPP cost about $280 per month to administer. The YMCA’s DPP is cheaper, generally costing no more than $75 per month to administer, but it lacks the technological integration, online access, social networking, and greater privacy that could make Prevent particularly useful for those trying to balance healthier choices with the day-to-day pressures of their busy lives. –AW
Amylin Pharmaceuticals, developer of the GLP-1 agonists Byetta and Bydureon (recently acquired by Bristol-Myers Squibb), has pledged to donate $5 to a diabetes charity for each person with type 2 diabetes who pledges to adopt a new healthy habit for one week as part of the This Week I Will Program. The ultimate goal is to raise $25,000 apiece for four major diabetes charities: the American Diabetes Association, the Behavioral Diabetes Institute, Diabetes Sisters, and the Diabetes Hands Foundation – this $100,000 goal will require 20,000 pledges, and This Week I Will is already over halfway there. The pledges call for simple changes, as participants can promise to eat a healthy breakfast each morning for a week, learn what their A1c numbers mean, take the stairs instead of the elevator, go on a 30-minute walk four times during the week, use smaller plates at mealtime, or substitute fruit in place of dessert or candy, among other options. When a person makes their particular pledge, This Week I Will sends them an email with tips and advice to help them follow through with their promise. For more information and to make your own pledge, visit http://www.diabeticconnect.com/ThisWeekIWill/. –AW
The Centers for Disease Control and Prevention (CDC) recently released a report tracking the skyrocketing prevalence of diabetes throughout all fifty states, the District of Columbia, and Puerto Rico. Adjusting for age, the prevalence of diagnosed diabetes in these 52 geographic areas increased from a 1995 median of 4.5% to 8.2% in 2010. Whereas in 1995 only three states, DC, and Puerto Rico had a prevalence of over 6%, now all 52 are above 6%. In terms of the relative increase in diabetes prevalence, 42 states experienced jumps of over 50%, while diabetes increased by more than 100% in 18 states, with Oklahoma experiencing the greatest increase of 227%. The South had the highest median prevalence of any region at 9.8%, and it is home to most of the states with prevalence over 10%. It should be noted that the CDC does not distinguish between type 1 and type 2 diabetes in these figures, but since type 2 accounts for well over 90% of all diabetes cases, these figures primarily speak to the increased prevalence of type 2 diabetes.
While these figures are certainly indicative of the significant increase in new diagnoses of diabetes since 1995, there is some small measure of optimism. As noted in the report, part of the reason why the prevalence of diabetes has increased so much is because people with diabetes now live significantly longer and healthier lives than they did in 1995 – indeed, the report notes that the mortality rate for people with diabetes dropped significantly between 1997 and 2006, at a rate much greater than that of people without diabetes. What’s more, the report points out that this increase in longevity has been accompanied by several improvements in the health of people with diabetes. –AW
The New England Journal of Medicine just published the results of a poll (1,290 votes from 75 countries) that asked readers to vote on the government regulation (e.g., taxes, bans) of sugar-sweetened beverages. An astounding 84% of voters from the rest of the world supported government regulation of sugar-sweetened beverages, compared to only 58% of voters from the United States. Authors Drs. James Colbert and Jonathan Adler attributed this marked difference to US history and culture (e.g., individualism, personal responsibility) and pointed to reader comments to help better explain the survey’s results. Those in support of government regulation argued that it was necessary to address the serious and wide-ranging public health concerns of obesity. Those against regulation emphasized the importance of education (rather than regulation) and that government intervention does not solve the fundamental problem: people need to change the way they live their lives.
Here at diaTribe, we’ve been hearing much more about the regulation of sugary drinks in recent politics and at conferences. In September 2012, the New York City Board of Health approved a ban on the sale of soda and sugar-sweetened drinks sold in containers larger than 16 ounces (see new now next in diaTribe #48). And as we noted in conference pearls in diaTribe #48, the topic of sugar-sweetened beverages received considerable attention at The Obesity Society conference. Dr. Steven Gortmaker (Harvard School of Public Health, Boston) estimated that a one cent per ounce tax on these drinks could reduce national health care costs by $1,700 per dollar spent, raise $12.7 billion each year in taxes, and lead to health benefits beyond those directly related to weight loss. Dr. Frank Chaloupka came to a similar conclusion: a penny per ounce tax on sugar-sweetened beverages would generate approximately $15 billion in additional revenue per year. Now wouldn’t that be something to put toward obesity education, subsidizing healthier foods, and exercise! Though there is not a one golden ticket solution to prevent and reduce obesity, we expect that these discussions and opinions of the government’s role will continue to evolve as the expansion of healthcare occurs through the Patient Protection and Affordable Care Act. –MN/AB