| Outcome Measures: |
Primary: Change in HbA1c, Change in HbA1c from Week 0 to Week 13, from Week 0 to Week 26, and from Week 13 to Week 26, 26 weeks | Secondary: Change in fasting blood glucose glucose levels, Difference in fasting blood glucose levels Mean Mixed Tolerance Test AUC,, 26 weeks|Hypoglycemia occurrences by category: Severe, Documented Symptomatic, and Asymptomatic Hypoglycemia, Comparison of frequency and severity of hypoglycemia, 26 weeks|Number of Patients with Adverse Events, • To demonstrate the safety of HDV insulin lispro over 26 weeks of administration., 26 weeks|Change in total insulin usage, • Comparison of basal and bolus insulin doses as a mean of 3 days of use at Week 0 and at 13 and 26 weeks, and comparison of total bolus insulin dosing at end of run-in phase to the end of the 13 week treatment period, and from the 13 week treatment period to the 26 week treatment period., 26 weeks|Change in Body Weight, Comparison of change in body weight (in Kilograms) from baseline through week 26., 26 weeks|Mean Mixed Meal Tolerance Test, Comparison of mean mixed meal tolerance test (MMTT) (AUC0-120) from Week 0 (baseline) to Week 13, from Week 0 (baseline) to Week 26, and from Week 13 to Week 26, 13 and 26 weeks
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| Locations: |
Hope & Wellness Clinical Trials, Inc., Corona, California, 92882, United States|National Research Institute, Los Angeles, California, 90057, United States|California Medical Research Associates Inc., Northridge, California, 91324, United States|Bay Area Clinical Research, San Carlos, California, 94070, United States|Mills-Peninsula Health Services, San Mateo, California, 94401, United States|Orange County Research Center, Tustin, California, 92780, United States|Creekside Endocrine Associates, PC, Denver, Colorado, 80209, United States|Advanced Pharma CR, LLC, Miami, Florida, 33147, United States|Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach, Florida, 32174, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Rocky Mountain Diabetes & Osteoporosis Center, PA, Idaho Falls, Idaho, 83404, United States|Associates in Endocrinology, Elgin, Illinois, 60124, United States|University of Massachusetts Memorial Hospital, Worcester, Massachusetts, 01655, United States|Desert Endocrinology Clinical Research Center, Henderson, Nevada, 89052, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|LION Research, Norman, Oklahoma, 73072, United States|Endocrine and Psychiatry Center, Houston, Texas, 77095, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Rainier Clinical Research Center, Inc., Renton, Washington, 98057, United States
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