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Diabetic hypoglycemia remains a critical concern in young patients

November 04, 2015

Dose ranging PK study ?? This Phase 1 clinical trial, which has been completed, began in 4Q08 and investigated the optimal insulin/PH20 ratios. Humalog and Humulin? R were tested with and without PH20 across a range of doses of insulin and concentrations of both PH20 and insulin in this euglycemic glucose clamp study and various PK parameters were measured in approximately 40 healthy subjects. Results of the study have been and will continue to be used to optimize dosing in future trials. Halozyme will present study results at the International Diabetes Federation Congress to be held on October 18-22, 2009 in Montreal and at the Diabetes Technology Society meeting in San Francisco on November 5-7, 2009. ClinicalTrials identifier: NCT00803972. Type 1 standard meal study ?? This Phase 2 clinical trial began in October 2008 and was completed in March 2009. It compared regular human insulin (Humulin R) with and without PH20 and lispro with and without PH20. Results from the study for the insulin analog, lispro, were presented at the American Diabetes Association meeting in June 2009. The study demonstrated faster insulin absorption and increased peak insulin plasma concentrations in type 1 diabetes patients for the combination of lispro with PH20. The results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal for the analog combination treatment. This study provided confirmation in type 1 diabetes patients of our previous pharmacokinetic findings with an analog insulin in healthy volunteers. Additional results from this study for Humulin R alone and in combination with PH20 have been accepted for presentation at the European Association for the Study of Diabetes (EASD) meeting in Vienna on October 1, 2009. ClinicalTrials identifier: NCT00705536. Type 2 standard meal study ?? This Phase 2 three-way crossover design study began in July 2009 and is fully enrolled with approximately 20 patients. It compares insulin lispro with PH20 and regular insulin with PH20 to lispro alone. The primary endpoint of this trial is the glycemic excursion over the first 4 hours. Secondary endpoints include the comparison of optimum doses of insulin required for glycemic control, as well as various PK, PD and safety endpoints. Type 2 diabetes patients typically must take higher doses of insulin and the effects of our enzyme may produce more pronounced absorption and concentration effects in this patient population. Results from this study in type 2 patients are expected in mid-2010. ClinicalTrials identifier: NCT00916357. Intra-subject variability study ?? This Phase 1 trial started in 1Q09 and is testing regular insulin with PH20, lispro with PH20 and lispro alone. It is a euglycemic glucose clamp study in 20 healthy subjects that measures PK and GD parameters over eight hours on two separate administrations with the same test dose of each study drug. Intrapatient insulin absorption can be highly variable and this study evaluates and quantifies the ability of PH20 to produce a more consistent PK profile relative to the PK variability produced by the insulin analog alone. Information regarding the consistency of insulin absorption and action has been collected and the results have been accepted for presentation at the Diabetes Technology Society meeting in San Francisco on November 5-7, 2009. ClinicalTrials identifier: NCT00862849.

In addition to the clinical pharmacology studies, the following registration trial-enabling treatment studies are ongoing or planned.

Insulin-PH20 type 1 treatment study ?? This Phase 2 clinical trial, which began in May 2009, will compare Insulin-PH20 (non-analog insulin) to lispro alone. After a one month observation period that includes dose optimization, patients were randomized to Insulin-PH20 or lispro and will be treated for three months. At the end of three months, patients crossover to the other study treatment for another three months. The study will evaluate safety and efficacy. Roughly 40 patients have been enrolled and results should be available in 3Q2010. Patients will self-administer their insulin three times daily on an outpatient basis. This study will provide insight into the ability of PH20 to improve regular insulin compared to treatment with analog insulin and will also provide important safety information with regard to chronic dosing for our PH20 enzyme. ClinicalTrials identifier: NCT00883558. Analog-PH20 type 1 treatment study ?? This Phase 2 clinical trial, targeted for initiation in mid-2010, will compare one or more Analog-PH20 candidates to analog alone. The double-blind study will be powered to assess safety over three months when administered three times daily with each meal, and to demonstrate the potential benefit of Analog-PH20 relative to the standard of care for key endpoints that may help drive commercial uptake.

Source: halozyme/