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Clinical Trial Details

Trial ID: L5511
Source ID: NCT02227875
Associated Drug: Mylan's Insulin Glargine
Title: Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Acronym: INSTRIDE 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02227875/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Mylan's insulin glargine|DRUG: Lantus®
Outcome Measures: Primary: Change in HbA1c From Baseline to 24 Weeks, 24 weeks | Secondary: Rate of Hypoglycemic Events Per 30 Days, The change from baseline at 12 and 24 weeks is reported, Baseline and up to 24 weeks|Hypoglycemia Occurrence, Overall hypoglycemic incidence during treatment period, 24 weeks|Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time, Comparison of change from Baseline in Immunogenicity, Week 12 and week 24|Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time, Comparison of change from Baseline in Immunogenicity, week 12 and week 24|Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time, Comparison of change from Baseline in Immunogenicity, week 12 and week 24|Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time, Comparison of change from Baseline in Immunogenicity, Week 12 and week 24
Sponsor/Collaborators: Sponsor: Mylan Inc. | Collaborators: Mylan GmbH
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 560
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-08
Completion Date: 2015-12
Results First Posted: 2020-08-13
Last Update Posted: 2022-03-03
Locations: Mylan Investigational Site, Chandler, Arizona, 85224, United States|Mylan Investigational Site, Bell Gardens, California, 90201, United States|Mylan Investigational Site, Fresno, California, 93720, United States|Mylan Investigational Site, Greenbrae, California, 94904, United States|Mylan Investigational Site, Long Beach, California, 90807, United States|Mylan Investigational Site, Los Angeles, California, 90057, United States|Mylan Investigational Site, Los Gatos, California, 95032, United States|Mylan Investigational Site, Mission Hills, California, 91345, United States|Mylan Investigational Site, National City, California, 47304, United States|Mylan Investigational Site, Northridge, California, 91324, United States|Mylan Investigational Site, Orange, California, 92868, United States|Mylan Investigational Site, Palm Springs, California, 92262, United States|Mylan Investigational Site, Spring Valley, California, 91978, United States|Mylan Investigational Site, Tustin, California, 92780, United States|Mylan Investigational Site, Walnut Creek, California, 94598, United States|Mylan Investigational Site, West Hills, California, 91307, United States|Mylan Investigational Site, Bradenton, Florida, 34208, United States|Mylan Investigational Site, Cooper City, Florida, 33024, United States|Mylan Investigational Site, Hialeah, Florida, 33012, United States|Mylan Investigational Site, Miami, Florida, 33142, United States|Mylan Investigational Site, Miami, Florida, 33156, United States|Mylan Investigational Site, New Port Richey, Florida, 34652, United States|Mylan Investigational Site, Palm Harbor, Florida, 34684, United States|Mylan Investigational Site, Pembroke Pines, Florida, 33028, United States|Mylan Investigational Site, Port Charlotte, Florida, 33952, United States|Mylan Investigational Site, West Palm Beach, Florida, 33401, United States|Mylan Investigational Site, Winter Haven, Florida, 33880, United States|Mylan Investigational Site, Columbus, Georgia, 31904, United States|Mylan Investigational Site, Gainesville, Georgia, 30501, United States|Mylan Investigational Site, Honolulu, Hawaii, 96814, United States|Mylan Investigational Site, Idaho Falls, Idaho, 83404, United States|Mylan Investigational Site, Chicago, Illinois, 60616, United States|Mylan Investigational Site, Crystal Lake, Illinois, 60012, United States|Mylan Investigational Site, Springfield, Illinois, 62704, United States|Mylan Investigational Site, Anderson, Indiana, 46011, United States|Mylan Investigational Site, Council Bluffs, Iowa, 51501, United States|Mylan Investigational Site, Des Moines, Iowa, 50314, United States|Mylan Investigational Site, Augusta, Kansas, 67010, United States|Mylan Investigational Site, Topeka, Kansas, 66606, United States|Mylan Investigational Site, Wichita, Kansas, 67207, United States|Mylan Investigational Site, Crestview Hills, Kentucky, 41017, United States|Mylan Investigational Site, Lexington, Kentucky, 40503, United States|Mylan Investigational Site, Waltham, Massachusetts, 02453, United States|Mylan Investigational Site, Kansas City, Missouri, 64114, United States|Mylan Investigational Site, Saint Louis, Missouri, 63128, United States|Mylan Investigational Site, Billings, Montana, 59101, United States|Mylan Investigational Site, Lincoln, Nebraska, 68516, United States|Mylan Investigational Site, Omaha, Nebraska, 68114, United States|Mylan Investigational Site, Omaha, Nebraska, 68131, United States|Mylan Investigational Site, Las Vegas, Nevada, 89119, United States|Mylan Investigational Site, Las Vegas, Nevada, 89128, United States|Mylan Investigational Site, Nashua, New Hampshire, 03063, United States|Mylan Investigational Site, Albany, New York, 12206, United States|Mylan Investigational Site, Hartsdale, New York, 10530, United States|Mylan Investigational Site, Smithtown, New York, 11787, United States|Mylan Investigational Site, Staten Island, New York, 10301, United States|Mylan Investigational Site, Asheville, North Carolina, 28803, United States|Mylan Investigational Site, Burlington, North Carolina, 27215, United States|Mylan Investigational Site, Cary, North Carolina, 27513, United States|Mylan Investigational Site, Greensboro, North Carolina, 27408, United States|Mylan Investigational Site, Greenville, North Carolina, 28590, United States|Mylan Investigational Site, Hickory, North Carolina, 28601, United States|Mylan Investigational Site, Morehead City, North Carolina, 28557, United States|Mylan Investigational Site, Wilmington, North Carolina, 28401, United States|Mylan Investigational Site, Cincinnati, Ohio, 45236, United States|Mylan Investigational Site, Cleveland, Ohio, 44122, United States|Mylan Investigational Site, Columbus, Ohio, 43201, United States|Mylan Investigational Site, Bend, Oregon, 97701, United States|Mylan Investigational Site, Charleston, South Carolina, 29407, United States|Mylan Investigational Site, Greer, South Carolina, 29651, United States|Mylan Investigational Site, Bristol, Tennessee, 34208, United States|Mylan Investigational Site, Kingsport, Tennessee, 37660, United States|Mylan Investigational Site, Memphis, Tennessee, 38119, United States|Mylan Investigational Site, Austin, Texas, 78731, United States|Mylan Investigational Site, Corpus Christi, Texas, 78404, United States|Mylan Investigational Site, Dallas, Texas, 75230, United States|Mylan Investigational Site, Dallas, Texas, 75231, United States|Mylan Investigational Site, El Paso, Texas, 79925, United States|Mylan Investigational Site, Houston, Texas, 77004, United States|Mylan Investigational Site, Houston, Texas, 77095, United States|Mylan Investigational Site, McKinney, Texas, 75070, United States|Mylan Investigational Site, Round Rock, Texas, 78681, United States|Mylan Investigational Site, San Antonio, Texas, 78258, United States|Mylan Investigational Site, Spring, Texas, 77379, United States|Mylan Investigational Site, Victoria, Texas, 77901, United States|Mylan Investigational Site, Ogden, Utah, 84405, United States|Mylan Investigational Site, Salt Lake City, Utah, 84102, United States|Mylan Investigational Site, Salt Lake City, Utah, 84109, United States|Mylan Investigational Site, Salt Lake City, Utah, 84121, United States|Mylan Investigational Site, South Jordan, Utah, 84095, United States|Mylan Investigational Site, Chesapeake, Virginia, 23321, United States|Mylan Investigational Site, Manassas, Virginia, 20110, United States|Mylan Investigational Site, Tacoma, Washington, 98405, United States|Mylan Investigational Site, Vancouver, Washington, 98405, United States|Mylan Investigational Site, Amman, Jordan|Mylan Investigational Site, Irbid, Jordan|Mylan Investigational Site, Seoul, Gyeonggi-do, Korea, Republic of|Mylan Investigational Site, Suwon-si, Gyeonggi-do, Korea, Republic of|Mylan Investigational Site, Seoul, 110744, Korea, Republic of|Mylan Investigational Site, Banska Bystrica, Slovakia|Mylan Investigational Site, Bardejov, Slovakia|Mylan Investigational Site, Bratislava, Slovakia|Mylan Investigational Site, Dolny Kubin, Slovakia|Mylan Investigational Site, Kosice, Slovakia|Mylan Investigational Site, Levice, Slovakia|Mylan Investigational Site, Sabinov, Slovakia|Mylan Investigational Site, Sahy, Slovakia|Mylan Investigational Site, Stropkov, Slovakia|Mylan Investigational Site, Sturovo, Slovakia|Mylan Investigational Site, Trebisov, Slovakia|Mylan Investigational Site, Trencin, Slovakia|Mylan Investigational Site, Zilina, Slovakia|Mylan Investigational Site, Johannesburg, Gauteng, South Africa|Mylan Investigational Site, Durban, KwaZulu-Natal, South Africa|Mylan Investigational Site, Cape Town, Western Cape, 7646, South Africa|Mylan Investigational Site, Cape Town, Western Cape, South Africa|Mylan Investigational Site, Worcester, Western Cape, South Africa|Mylan Investigational Site, Bloemfontein, South Africa|Mylan Investigational Site, Kaohsiung, Taiwan|Mylan Investigational Site, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT02227875

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress