Data Demonstrating Potential Benefits of Simple Insulin Delivery Device Presented at European Association for the Study of Diabetes Annual Meeting

- Data suggest PaQ ® may help people with type 2 diabetes maintain better glycemic control

HORW, Switzerland, Sept. 24, 2013 /PRNewswire/ -- CeQur® SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that comprehensive data from a study of the company's PaQ® Insulin Delivery Device were presented today at the 49^th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona.

The data suggest that the discreet, wearable PaQ device can potentially improve glycemic control among people with type 2 diabetes, and is associated with both high patient acceptance and satisfaction.

Previous research suggests that approximately 50 percent of insulin-requiring individuals do not achieve appropriate glycemic control.[1] Half of all patients requiring multiple-daily insulin injections (MDIs) report they intentionally skip doses because they consider the injections embarrassing, inconvenient, painful, and/or disruptive to their daily activities.[2] Continuous, subcutaneous insulin infusion (CSII) is an alternative to insulin injections, but adoption has been limited by the complexity and cost of existing, approved CSII devices.

"We are extremely gratified to have developed a simple CSII device with demonstrated ability to safely and effectively address many of the issues that make daily injection therapy a challenge," said James Peterson, founder and CEO, CeQur. "We believe PaQ creates tremendous value by freeing people from the daily injection burden, thereby enabling intensive insulin therapy and reducing the impact of diabetes on patients' lives."

Julia Mader, MD, presented findings from a 20-patient study conducted at the University Hospital in Graz, Austria that evaluated the ability of people with type 2 diabetes (T2D) who were on a stable MDI regimen to use PaQ in replacing the insulin injections required to control their blood sugar (Poster #1109). Study endpoints included glycemic control, patient satisfaction and safety.

Changes in self-monitored blood glucose values during PaQ therapy showed a trend toward better glycemic control compared to baseline at multiple points throughout the day. Blinded continuous glucose monitoring (CGM) data during PaQ therapy also revealed a trend toward improved glycemic control. The reduction in glucose exposure occurred overnight and during the day, and CGM revealed no episodes of severe hypoglycemia.

"Previous studies have demonstrated that CSII may improve treatment satisfaction among people with type 2 diabetes and may thereby improve glycemic control or willingness to switch to insulin," said John Pickup, MD, professor of Diabetes and Metabolism at the Kings College London School of Medicine. "But we need devices that are less complex and more affordable. Simpler insulin delivery devices such as the PaQ are both clinically and economically justified for type 2 diabetes."

Previously presented data from the Graz study demonstrate that PaQ safely and effectively delivered patients' insulin requirements. No severe hypoglycemic events occurred during the study baseline period or while participants were on PaQ, and all patients were able to correctly assemble and use PaQ with just one hour of training.

CeQur recently announced the closing of a $27 million dollar Series B financing that will support manufacturing scale up for PaQ, which received CE Mark approval in November 2012, and fund activities related to United States regulatory approval. 

The Need for Simple Insulin Infusion

There are currently more than 11 million people in the United States and European Union who are taking insulin injections to manage their T2D.  Studies suggest that simple CSII regimens may improve glycemic control and quality of life among these individuals. However, current CSII has not been widely used in T2D to date due to its complexity and cost.

About PaQ

PaQ is a discreet, wearable device that provides three days of consistent, basal insulin delivery along with easy, on-demand bolus insulin. The small device comprises a disposable insulin infuser reservoir attached to a reusable insulin monitor.

About CeQur® SA

CeQur is dedicated to developing and commercializing advanced insulin delivery devices that make it easier for people living with type 2 diabetes to adhere to therapy and stay in control of  their disease. The company is headquartered in Horw, Switzerland, with operations in Nordborg, Denmark and Marlborough, Massachusetts.

CeQur was established in January 2008.  The company's lead product candidate is the PaQ Insulin Delivery Device, a novel, wearable device that provides freedom from multiple daily injections.  More information can be found at www.cequrcorp.com.  

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[1] Hoerger, T et. al. Is Glycemic Control Improving in U.S. Adults? Diabetes Care 2008, 31:81-86

[2] Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010;33:240-5