| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period, Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect., Baseline, Week 12 and Week 24 | Secondary: Mean Daily Insulin Dose, Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts)., Week 10 and Week 22|Percentage of Participants Meeting Glucose Targets, Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of \<140 and \<180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts)., Baseline through Week 24, excluding 10-point glucose monitoring days|Rates of Hypoglycemia at the End of Each Treatment Period, Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter \[mg/dL\] and \<56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module., Week 12 and Week 24|Change From Baseline in Body Weight at the End of Each Treatment Period, Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts)., Baseline, Week 12 and Week 24|Mean Daily Postprandial Glucose (PPG) Excursions, Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented., Week 10 and Week 22
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| Locations: |
AMCR Institute, Inc., Escondido, California, 92026, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|Mills-Peninsula Health Services, San Mateo, California, 94401, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|Center for Diabetes and Endocrine Care, Hollywood, Florida, 33021, United States|Diabetes Research Institute, Miami, Florida, 33136, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Mid-America Diabetes Associates, Wichita, Kansas, 67211, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, 70112, United States|Medstar Research Institute, Hyattsville, Maryland, 20782, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Mercury Street Medical, Butte, Montana, 59701, United States|Desert Endocrinology, Henderson, Nevada, 89052, United States|UT Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States|Texas Diabetes and Endocrinology, Round Rock, Texas, 78681, United States|Cetero Research-San Antonio, San Antonio, Texas, 78229, United States|West Olympia Internal Medicine, Olympia, Washington, 98502, United States|University of Washington School of Medicine, Seattle, Washington, 98105, United States
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