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Clinical Trial Details

Trial ID: L5100
Source ID: NCT02106364
Associated Drug: Insulin Peglispro
Title: A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Peglispro|DRUG: Insulin Glargine
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
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-02
Completion Date: 2016-06
Results First Posted:
Last Update Posted: 2016-03-28
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
URL: https://clinicaltrials.gov/show/NCT02106364