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Clinical Trial Details

Trial ID: L2955
Source ID: NCT03376789
Associated Drug: Myl-1501d Product Using Manufacture Process V
Title: Mylan Insulin Glargine Study
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03376789/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: MYL-1501D product using manufacture process V|DRUG: MYL-1501D product using manufacture process VI
Outcome Measures: Primary: Change in HbA1c, Change in HbA1c from baseline, Baseline to Week 18 | Secondary: Change in FPG, Change in fasting plasma glucose from baseline, Baseline to Week 18|Change in Insulin Dose, Change in daily total insulin dose per unit body weight (U/kg) from baseline, Baseline to Week 18|Change in 8-point SMBG, Change in 8-point self-monitored blood glucose (SMBG) daily average, Baseline to Week 18
Sponsor/Collaborators: Sponsor: Mylan Inc. | Collaborators: Mylan GmbH
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 219
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-11-29
Completion Date: 2019-01-10
Results First Posted: 2022-03-03
Last Update Posted: 2022-03-03
Locations: Mylan Investigator Site, Fresno, California, 93720, United States|Mylan Investigator Site, Greenbrae, California, 94904, United States|Mylan Investigator Site, Huntington Beach, California, 92648, United States|Mylan Investigator Site, La Mesa, California, 91942, United States|Mylan Investigator Site, Los Gatos, California, 95032, United States|Mylan Investigator Site, Mission Hills, California, 91345, United States|Mylan Investigator Site, Montclair, California, 91763, United States|Mylan Investigator Site, Northridge, California, 91324, United States|Mylan Investigator Site, Oakland, California, 94607, United States|Mylan Investigator Site, Santa Monica, California, 90404, United States|Mylan Investigator Site, Tarzana, California, 91356, United States|Mylan Investigator Site, Tustin, California, 92780, United States|Mylan Investigator Site, Walnut Creek, California, 94598, United States|Mylan Investigator Site, Denver, Colorado, 80246, United States|Mylan Investigator Site, Bradenton, Florida, 34201, United States|Mylan Investigator Site, Fort Lauderdale, Florida, 33312, United States|Mylan Investigator Site, Fort Myers, Florida, 33912, United States|Mylan Investigator Site, Hialeah, Florida, 33012, United States|Mylan Investigator Site, Maitland, Florida, 32751, United States|Mylan Investigator Site, Miami, Florida, 33126, United States|Mylan Investigator Site, Miami, Florida, 33156, United States|Mylan Investigator Site, Miami, Florida, 33175, United States|Mylan Investigator Site, New Port Richey, Florida, 34652, United States|Mylan Investigator Site, Palm Harbor, Florida, 34684, United States|Mylan Investigator Site, Saint Petersburg, Florida, 33709, United States|Mylan Investigator Site, Spring Hill, Florida, 34609, United States|Mylan Investigator Site, Tampa, Florida, 33634, United States|Mylan Investigator Site, West Palm Beach, Florida, 33401, United States|Mylan Investigator Site, Atlanta, Georgia, 30318, United States|Mylan Investigator Site, Columbus, Georgia, 31904, United States|Mylan Investigator Site, Lawrenceville, Georgia, 30045, United States|Mylan Investigator Site, Roswell, Georgia, 30076, United States|Mylan Investigator Site, Idaho Falls, Idaho, 83404, United States|Mylan Investigator Site, Meridian, Idaho, 83642, United States|Mylan Investigator Site, Springfield, Illinois, 62701, United States|Mylan Investigator Site, Council Bluffs, Iowa, 51501, United States|Mylan Investigator Site, Austin, Texas, 78731, United States|Mylan Investigator Site, Dallas, Texas, 75231, United States
URL: https://clinicaltrials.gov/show/NCT03376789

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress