Medtronic (NYSE:MDT) and Intarcia Therapeutics were in the spotlight at the American Diabetes Assn.’s annual scientific sessions conference in Boston last week, revealing new medical device developments in the fight against diabetes.
Medtronic took center stage, announcing new developments for its artificial pancreas program, touting positive data from a user study of its MiniMed 640g and revealing plans to collaborate with Becton Dickinson & Co. (NYSE:BDX) on a new infusion set.
Boston, Mass.-based Intarcia also revealed new data on its Type II diabetes drug-device combination from 2 new studies, as the company continues towards FDA approval.
Medtronic works towards an artificial pancreas
Medtronic said information from a user evaluation of its MiniMed 640G showed reductions in low-blood glucose, and that it enrolled its 1st patient in a pivotal trial of its “Hybrid Closed Loop” system designed to control glucose levels with minimal patient input.
The Fridley, Minn.-based medical device giant said data from the user evaluation showed the device’s SmartGuard system, designed to suspend insulin delivery when a low-glucose level is predicted, was able to manage glucose levels in 83.1% of low-glucose events without glucose levels reaching hypoglycemic limits.
“Severe hypoglycemia can have devastating effects on people with diabetes and even milder episodes can really impair quality of life. The more we can do to minimize the impact of hypoglycemia, the better we can make lives of people with diabetes. That is why patients in our user evaluation really loved MiniMed 640G with SmartGuard technology, because it effectively and unobtrusively reduced hypoglycemia,” lead investigator Dr. Pratik Choudhary of King’s College London said in a press release.
Medtronic also said it enrolled the 1st patient in a pivotal study of its “Hybrid Closed Loop” system, designed to automatically control glucose levels with only carbohydrate data at mealtime and occasional sensor calibrations.
“Insulin pumps and continuous glucose monitoring systems have greatly improved the ability for people with diabetes to achieve better glucose control and live longer, healthier lives. However, even with these systems, patients must make hundreds of decisions each day. Simplifying this self-management with a more automated Hybrid Closed Loop system would have a very meaningful impact on these patients’ lives,” Dr. Satish Gargof the University of Colorado’s Barbara Davis Center for Childhood Diabetes said in a prepared statement.
Medtronic claimed it would be the 1st pivotal trial of a closed loop system conducted in the U.S. The single-arm, multi-center clinical study is slated to enroll 150 Type I diabetics, the company added.
“After years of research and development, the critical components of a closed loop system are here. We are thrilled to be partnering with the world’s leading investigators to do the clinical work to bring this technology to market so that it can help people with diabetes enjoy even greater freedom and better health,” Medtronic chief medical officer Dr. Francine Kaufman said in prepared remarks.
Medtronic to collaborate with BD on new insulin pump infusion set
Medtronic and BD’s medical division said they’re collaborating to produce and market a new insulin pump infusion set. The deal calls for Medtronic to commercialize the set, with BD Medical manufacturing the product, the companies said. The device will utilize BD’s FlowSmart technology, which features a side-ported catheter designed to improve insulin flow and reduce flow interruptions.
“We are very excited to partner with a global leader like Medtronic to ensure that the benefits of BD FlowSmart technology can be made widely available to as many people living with diabetes as possible. By increasing the reach and availability of this technology, we have an opportunity to enhance the use of insulin pump therapy by providing potentially more consistent insulin delivery and fewer flow interruptions. This technology is an extension of BD’s long-standing commitment to deliver injection solutions, and builds on previous BD research that has advanced the science and understanding of insulin delivery as well as patient comfort,” BD Medical diabetes care worldwide president Kenneth Miller said in a press release.
The companies said the infusion set won FDA 510(k) clearance in April, Health Canada approval in January, and that an application has been submitted for CE Mark approval in the European Union. The companies expect a launch by 2016.
“Medtronic is committed to advancing innovation across the entire insulin pump system, including infusion sets, to improve outcomes and expand options to satisfy different patient needs, body types and lifestyles. Our partnering with diabetes technology leaders, such as BD, will give more people with diabetes access to these innovations so they can enjoy greater freedom and better health,” vice president of diabetes services and solutions Annette Brüls said in a prepared statement.
Intarcia Therapeutics touts positive data on drug-device combo
Intarcia Therapeutics said data from 2 studies of its ITCA 650 drug-device treatment showed positive data on key endpoints.
Data from the company’s 39-week Freedom-1 Phase III trial showed significant HbA1c reductions and weight reductions in patients treated with the device, the company said.
HbA1c reductions, which is hemoglobin tied to blood sugar, were at 1.4% in treated patients; mean weight loss was 4kg in treated patients, double the 2kg loss in the placebo group, the Boston-based company said.
“Reaching and sustaining recommended blood glucose levels and weight loss are important but very difficult goals to achieve and maintain for the majority of patients with Type II diabetes. These positive Phase III trial results suggest ITCA 650 holds the potential to open up a new treatment approach to address the significant unmet needs for enhancing treatment adherence to help bring more patients into glycemic control in the growing epidemic of Type II diabetes,” lead investigator Dr. Julio Rosenstock, of the Dallas Diabetes & Endocrine Center, said in a press release.
Complications were minimal and adverse events associated with administration of the device were mild or transient, the company said. Discontinuation rate for nausea was in the low single digits, Intarcia said.
A 2nd study of 60 patients with high baseline levels of hemoglobin also showed a significant reduction in HbA1c, the company said. Patients from the 2nd trial showed a mean reduction in HbA1c of 3.4%, according to the study.
“I am very pleased with these Phase III results. ITCA 650 delivered excellent results for such a high risk and refractory patient population – and all of this without the need for regular self-injections. I think these new data indicate that the ITCA 650 method of delivery may provide an uninterrupted, smooth and continuous dose that delivers powerful reductions in HbA1c without the need for patient action in terms of managing their medication, which we all know can be extremely challenging. With continued success in the remaining Phase III trials this year, and a corresponding approval by regulatory authorities, the diabetes community, including payers, providers and patients, could have a new therapeutic choice that may fundamentally change the way we treat diabetes. We desperately need new innovations to positively affect the treatment of this devastating and growing epidemic worldwide,” University of California San Diego’s Dr. Robert Henry said in a prepared statement.
Two more Phase III trials are being conducted by Intarcia as it seeks FDA approval, the company told The Boston Business Journal, with over 5,000 patients enrolled in 1 of the studies.
Intarcia has raised more than $1 billion in funding, after announcing in April a $225 million round it plans to use to run clinical trials and commercialize its the drug-device combination treatment it’s developing for Type II diabetes.
Intarcia, which last year inked a $1 billion development deal with French pharmaceutical independent Servier, raised a $210 million round back in November 2012. Last year saw another $200 million addition, plus a $171 million up-front payment from Servier, a company spokeswoman told MassDevice.com, on top of “several” previous bridge rounds of undisclosed amounts.
More news from the ADA meeting
Valeritas said data from 2 studies of its V-Go disposable insulin delivery device showed significant HbA1c reductions on less insulin across the board, and that significant HbA1c results were maintained for 9 months while using up to 40% less insulin from baseline.
GI Dynamics (ASX:GID) said a new study of its EndoBarrier therapy in 30 obese patients with Type II diabetes showed improvements in multiple glycemic parameters and sustained lower body weight and body fat.
Glytec said new studies show positive effects of its electronic glucose management systems in newly diagnosed patients, as well as patients with kidney disease and renal or hematopoietic cell transplants.