Halozyme Therapeutics announced results from a Phase 2 study of prandial insulin formulations, which include the Company’s recombinant human hyaluronidase (rHuPH20) enzyme, in patients with Type 1 diabetes. The study met its primary endpoint of A1C non-inferiority. Further, data from the study indicated that rHuPH20 reduced postprandial glycemic excursions, as well as significantly reduced hypoglycemic events.
“There is a real need for faster-acting mealtime insulins. By accelerating the absorption and action of prandial insulins, rHuPH20 may help reduce mealtime glucose fluctuations that make managing diabetes difficult,” said Irl B. Hirsch, M.D., Professor of Medicine, Diabetes Treatment and Teaching Chair, University of Washington School of Medicine. “This faster-in, faster-out profile may also attenuate the risk of hypoglycemia. In this study, improved control of mealtime glucose significantly reduced hypoglycemic events in patients receiving treatments with the rHuPH20 enzyme. The data further indicated that Halozyme’s ultrafast insulin formulations moderate glucose swings, thus more closely mimicking the effects of endogenous insulin and, if approved, could ultimately help patients with diabetes live healthier lives.”
The study compared two rapid acting insulin analog products (lispro or aspart), formulated with rHuPH20 (lispro-PH20 and aspart-PH20, each an Analog-PH20), to an active comparator (lispro alone). The study met the primary endpoint, showing that the Analog-PH20 formulations were non-inferior for A1C, compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.05, +.15). Patient groups in all treatment arms of this study achieved excellent blood glucose control, with endpoint A1C values <6.9%. Data from the study also showed that mean post-meal glycemic excursions (measured at 90 minutes) in the patient groups treated with Analog-PH20 were reduced by 82 percent (p=.0045), with more patients consistently achieving post-prandial glucose targets for at least two-thirds of their meals, as compared with the patient group treated with lispro alone. For those patient groups treated with Analog-PH20, overall hypoglycemic rates as defined by the ADA (glucose <70 mg/dL) were reduced by 5 percent (p=.035) and hypoglycemic events as defined by a more stringent definition (glucose <56 mg/dL) by 7 percent (p=.044), as compared with the patient group treated with lispro alone.
Additionally, over the 12 week study period total daily insulin dose with the Analog-PH20 treatment groups was comparable (54+27 U vs. 56+27 U, p=.057) as was weight change (-0.25 lbs. vs. +0.10 lbs., p=.27), compared with the patient group treated with lispro alone. Adverse events were also comparable between treatments, with no meaningful difference in adverse events, immunogenicity or injection site pain and Analog-PH20 was well tolerated. Treatment phase severe adverse events were limited to hypoglycemia, which occurred in two subjects treated with lispro alone.