Positive Results from First Human Clinical Trials of a First-Generation Artificial Pancreas System is Significant Step Forward for Millions with Type 1 Diabetes
System in Development from Animas-JDRF Partnership Successfully Detects Highs and Lows and Automatically Adjusts Insulin Delivery in Clinical Setting with No Safety Concerns
WEST CHESTER, Pa., June 11, 2012 – Results from the first feasibility study of an advanced first-generation artificial pancreas system were presented today at the 72nd Annual American Diabetes Association Meeting in Philadelphia. Findings from the study indicated that the Hypoglycemia-Hyperglycemia Minimizer (HHM) System was able to automatically predict a rise and fall in blood glucose and correspondingly increase and/or decrease insulin delivery safely. The HHM System included a continuous, subcutaneous insulin pump, a continuous glucose monitor (CGM) and special software used to predict changes in blood glucose. The study was conducted by Animas Corporation in collaboration with JDRF as part of an ongoing partnership to advance the development of a closed-loop artificial pancreas system for patients with Type 1 diabetes.
“The successful completion of this study using the HHM System in a human clinical trial setting is a significant step forward in the development of an advanced first-generation artificial pancreas system,” said Dr. Henry Anhalt, Animas Chief Medical Officer and Medical Director of the Artificial Pancreas Program. “It lays the foundation for subsequent clinical trials, bringing us one step closer to making the dream of an artificial pancreas a reality for millions of people living with Type 1 diabetes.”
In June 2011, Animas received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to proceed with human clinical feasibility studies for the development of a closed-loop artificial pancreas system. The company partnered with the JDRF in January 2010 to begin developing such an automated system to help people living with Type 1 diabetes better control their disease.
“We are encouraged by the results of the first human trials in this partnership with Animas,” said Aaron Kowalski, Ph.D., Assistant Vice President of Research at JDRF. “An artificial pancreas system that can not only detect, but can predict high and low blood sugar levels and make automatic adjustments to insulin delivery would be a major advance for people with Type 1 diabetes. Such a system could alleviate a huge burden of managing this disease.”
About the Studies
The trial was a non-randomized, uncontrolled feasibility study of 13 participants with Type 1 diabetes at one trial site in the United States. The investigational Hypoglycemia-Hyperglycemia Minimizer (HHM) system was studied for approximately 24 hours for each study participant during periods of open and closed loop control via a model predictive control algorithm with a safety module run from a laptop platform. Insulin and food variables were manipulated throughout the study time period to challenge and assess the system.
The primary endpoint was to evaluate the ability of the algorithm to predict a rise and fall in glucose above or below set thresholds and to command the pump to increase, decrease, suspend and/or resume insulin infusion accordingly. The secondary endpoint was to understand the HHM system’s ability to safely keep glucose levels within a target range and to provide guidance for future system development. The study also examined the relationship between CGM trends and the control model’s algorithm for insulin delivery.
About Animas Corporation
As part of the Johnson & Johnson Family of Companies, Animas is dedicated to creating a world without limits for people with diabetes through a wide range of products, including the OneTouch® Ping® Glucose Management System and the Animas® 2020 insulin pump. Animas, from the Latin word meaning “true inner self or soul,” has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit http://www.animas.com/.
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Animas Corporation and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Animas Corporation nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is now the largest charitable supporter of T1D research. The goal of JDRF research is to improve the lives of all people affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal.
Since its founding in 1970, JDRF has awarded more than $1.7 billion to diabetes research. Past JDRF efforts have helped to significantly advance the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. More than 80 percent of JDRF’s expenditures directly support research and research-related education.