Outcome Measures: |
Primary: Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint, Baseline, 26 Weeks | Secondary: Proportion of Participants with HbA1c ≤6.5% and <7.0%, Week 26 and Week 52|Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event, Baseline through 26 Weeks and Baseline through 52 Weeks|Rate of Total and Nocturnal Hypoglycemia Events, Baseline to 26 Weeks|Fasting Serum Glucose (FSG) by Laboratory Measurements, 26 Weeks|9 Point Self Monitored Blood Glucose, 26 Weeks|Change from Baseline in Body Weight at Week 26 Endpoint, Baseline, 26 Weeks|Change from Baseline in HbA1c at 52 Week Endpoint, Baseline, Week 52|Insulin Dose by Unit, 26 Weeks|Time to Reach Steady-State, Baseline through 52 Weeks|Fasting Blood Glucose by Self Monitoring, Baseline through 52 Weeks|Intra-Participant Variability in Fasting Blood Glucose, Baseline through 52 Weeks|Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score, Baseline, Week 26, Week 52|Change from Baseline in the Low Blood Sugar Survey (LBSS), Baseline, Week 26, Week 52|Number of Participants Developing Anti-Insulin Peglispro Antibodies, Week 26 and Week 52|Change from Baseline in Lipid Profile, Baseline, Week 26
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Locations: |
Rheumatology Associates PC, Birmingham, Alabama, 35205, United States|Florida Medical Clinic PA, Zephyrhills, Florida, 33542-7505, United States|Diagnostic Rheumatology and Research, Indianapolis, Indiana, 46227, United States|Heartland Research Associates, Wichita, Kansas, 67207, United States|Washington University Medical Center, Saint Louis, Missouri, 63110, United States|Albuquerque Rehabilitation & Rheumatology, PC, Albuquerque, New Mexico, 87102, United States|PMG Research of Hickory, LLC, Hickory, North Carolina, 28602, United States|Carolina Arthritis Associates, Wilmington, North Carolina, 28401, United States|STAT Research, Dayton, Ohio, 45417, United States|Apex Clinical Research, Kennewick, Washington, 99336, United States
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