| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period, Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (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 as Recorded During 10-Point Glucose Monitoring, Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during 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) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are 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 at Least 2/3 of the Time, 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 was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by 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, The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and \<56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, 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 groups). 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, Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are 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 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 PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are 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
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| Locations: |
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Medical Group of Encino, Encino, California, 91436, United States|AMCR Institute, Inc., Escondido, California, 92026, United States|Marin Endocrine Care and Research, Greenbrae, California, 94904, United States|Mills-Peninsula Health Services, San Mateo, California, 94401, United States|Center for Diabetes and Endocrine Care, Hollywood, Florida, 33021, United States|Diabetes Research Institute, Miami, Florida, 33136, United States|Baptist Diabetes Associates, Miami, Florida, 33156, 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|Diabetes and Endocrinology Associates, PC, Morehead, North Carolina, 28557, 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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