FDA approves Medtronic's LGS IDE for clinical trial to treat Type 1 diabetes

In our continued commitment to develop an artificial pancreas, Medtronic, Inc. (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE study of the MiniMed Paradigm^® System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic's ASPIRE study the first in-home pivotal trial of a closed loop system for Type 1 diabetes management.

"This study leads an industry-wide effort to close the diabetes treatment loop by tackling the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react," said David Klonoff, Medical Director of the Diabetes Research Institute at Mills-Peninsula Health Services. "The new Low Glucose Suspend integrated system is designed to help improve patients' ability to manage nocturnal hypoglycemia, which can be one of the most frightening aspects of living with Type 1 diabetes. Until now, we have never had a therapy designed to automatically intervene when blood glucose becomes severely low."

"FDA approval of the ASPIRE in-home study is an important milestone toward bringing Low Glucose Suspend technology to the U.S. market," said Dr. Francine Kaufman, Chief Medical Officer and Vice President of Global Clinical Affairs for the Diabetes business of Medtronic. "It's also a critical step toward our ultimate goal — the development of an artificial pancreas. We believe this innovation has the potential to provide patients with added protection by lowering the risks associated with nocturnal hypoglycemia."

This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic's newest continuous glucose sensor, the Enlite^™ sensor, will be tested as part of the overall system.

ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF in the actual use environment and by the intended use population with Type 1 diabetes. The first study objective is to demonstrate that home use of LGS is safe and is not associated with glycemic deterioration, as measured by a change in HbA1C. The second study objective is to demonstrate that home use of LGS is associated with a reduction in nocturnal hypoglycemia when patients fail to respond. Hypoglycemia is a common occurrence and concern in diabetes management and can result in confusion, unresponsiveness and — in severe cases — even death.

"FDA review of the ASPIRE IDE application was conducted through an interactive review process that involved frequent communication with the FDA review team, allowing issues to be resolved quickly and avoiding any unnecessary delays during the review. We appreciate the valuable input provided by members of the FDA's Artificial Pancreas Working Group," added Dr. Kaufman.