New Inhaled Insulin Qdose Shows Positive Results in Study

Peak levels achieved more quickly then subcutaneous insulin injection and was safe and effective.

MicroDose Technologies, Inc., a privately held drug delivery and specialty pharmaceuticals company announced Monday the results from a glucose clamp study of the QDose inhaled insulin product. MicroDose, through its joint venture with Vectura Group plc, QDose Limited, has developed a highly efficient, rapid acting, insulin inhaler, based upon MicroDose’s proprietary electronic inhaler technology and Vectura’s dry powder insulin formulation. The QDose inhaled insulin product offers dose titration capability over a broad range of dose strengths, in a single inhalation.  The inhaler also provides active dose feedbacks to the patient in an easy to use, pocket-sized device.

The study employed the widely used and validated glucose clamp technique, and results demonstrated that:
–The inhaled insulin formulation was safe and effective

— Peak levels of insulin activity were achieved more quickly than those from the subcutaneous insulin injection 

   
— Relative bioavailability of inhaled insulin was approximately 18% during the 3 hour period following dosing; higher than the published values for the currently marketed inhalation product

— Administration of the same total dose of inhaled insulin from either single blister or two "half strength" blisters led to equivalent activity; an advantage over the currently marketed inhalation product

The study was a randomized, crossover, open-label glucose clamp study, designed to confirm the high relative bioavailability of the QDose insulin formulation previously observed, and to demonstrate the product’s dose titration capability.  The results confirmed the faster onset of action seen with the QDose inhaled formulation compared with subcutaneous insulin.  The relative bioavailability observed in this study compares favorably with available information on competitor inhaled insulin programs.  The study was conducted in the United States at Profil Institute for Clinical Research Inc (Profil) in San Diego, with 14 healthy male volunteers, using a glucose clamp technique.
For further information please visit www.icrodose-tech.com

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DID YOU KNOW:
Diabetes Increases Hospital Complications for Trauma Patients: Diabetes complicates hospital trauma care much as it does for in-patient acute care, researchers here reported. Data from Pennsylvania trauma centers over 18 years showed that hospitalized patients with diabetes were almost twice as likely as non-diabetics with injuries of similar severity to have a complication, although mortality rates were the same, reported Robert A. Cherry, M.D., of Penn State, and colleagues. Studies have shown that diabetic patients have more complications and worse outcomes after hospitalization for stroke, myocardial infarction, and cardiothoracic surgery, but little had been known about outcomes for diabetic trauma patients, the authors noted. Ahmad R, et al "Increased Hospital Morbidity Among Trauma Patients With Diabetes Mellitus Compared With Age- and Injury Severity Score-Matched Control Subjects." Arch Surg. 2007; 142: 613-618.

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