SAN DIEGO – Recombinant human hyaluronidase combined with human regular insulin yielded comparable glycemic responses to lispro insulin in a study of 46 patients with well-controlled type 1 diabetes.
Recombinant human hyaluronidase (rHuPH20) is approved by the Food and Drug Administration to increase the dispersion and absorption of other injected drugs. This randomized, open-label, crossover study investigated whether a combination of rHuPH20 with human regular insulin (Halozyme Therapeutics' investigational Insulin-PH20) could produce glycemic control comparable to that of the currently available rapid-acting analogues. The ultimate aim is to combine it with those to make an even faster-acting analogue, Dr. Satish K. Garg said at the meeting.
“If we really want to achieve euglycemia in the postprandial phase, especially 1 and 2 hours after meals, we need an ultra–fast-acting insulin, and we don't have that,” said Dr. Garg, professor of medicine and pediatrics at the University of Colorado, Denver.
The 46 patients had a mean age of 42 years, a mean body mass index of 26 kg/m
The prespecified primary end point was a noninferiority margin of post-prandial glucose values not exceeding 21.6 mg/dL for three meals over 3 days. The difference in glycemic excursions between the two insulin formulations was 2.4 mg/dL, clearly meeting the end point, Dr. Garg said.
HbA1c was maintained for both groups in the trial, 7.0% for Insulin-PH20 and 6.9% for lispro, meeting the commonly applied noninferiority margin of 0.4%. Continuous glucose monitoring during the last 2 weeks of each treatment period showed similar mean glucose values (153 vs. 143 mg/dL), with similar amounts of time spent in the target range of 70-130 mg/dL (39% vs. 44%).
There were no significant differences in overall hypoglycemia, defined as blood glucose value of 70 mg/dL or below.
Dr. Garg has received grants and honoraria from Halozyme Therapeutics, Sanofi-Aventis, Novo-Nordisk, Dexcom, and Eli Lilly.
To view an interview with Dr. Garg, simply scan this QR code using your smartphone.