Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.
The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
48
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Diabetes Research Institute
Miami, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercury Street Medical
Butte, Montana, United States
Postprandial Glucose Excursion
A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.
Time frame: Week 14 and Week 26
Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring
Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.
Time frame: Week 14 and Week 26
Number of Participants With Hypoglycemic Events
The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline through Week 29
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UNC Diabetes Care Center/Highgate Specialty Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
West Olympia Internal Medicine
Olympia, Washington, United States