Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
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.
Diabetes Mellitus, Type 1
Drug: Insulin Lispro
Drug: regular human insulin
Drug: recombinant human hyaluronidase PH20
Drug: Insulin glargine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes|
- Postprandial Glucose Excursion [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]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 Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]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.
- Number of Participants With Hypoglycemic Events [ Time Frame: Baseline through Week 29 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: INSULIN-PH20 NP / Insulin Lispro
All enrolled participants underwent a 1-month dose titration period and received 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC) pre-meals, with doses titrated to each participant individually.
Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.
INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump.
Drug: Insulin Lispro
Other Name: HumalogDrug: regular human insulin
Other Name: Humulin RDrug: recombinant human hyaluronidase PH20
Other Names:Drug: Insulin glargine
Other Name: Lantus
The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883558
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Diabetes Research Institute|
|Miami, Florida, United States, 33136|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Montana|
|Mercury Street Medical|
|Butte, Montana, United States, 59701|
|United States, North Carolina|
|UNC Diabetes Care Center/Highgate Specialty Center|
|Durham, North Carolina, United States, 27713|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Texas Diabetes and Endocrinology|
|Austin, Texas, United States, 78731|
|United States, Washington|
|West Olympia Internal Medicine|
|Olympia, Washington, United States, 98502|
|Study Director:||Douglas Muchmore, M.D.||Halozyme Therapeutics|