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Clinical Trial Details

Trial ID: L2939
Source ID: NCT02273180
Associated Drug: Sar342434
Title: Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Acronym: SORELLA1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02273180/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: SAR342434|DRUG: Humalog|DRUG: Insulin glargine HOE901
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26., Baseline, Week 26 | Secondary: Percentage of Participants With HbA1c <7.0% at Week 26, Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders., Week 26|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26., Baseline, Week 26|Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26, Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26., Baseline, Week 26|Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26, Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26., Baseline, Week 26|Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year, Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (\<3.0 mmol/L) were also analyzed., First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions, Percentage of participants with hypersensitivity reactions and injection site reactions were reported., First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs), Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA)., First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) | Other: Change in Daily Insulin Dose From Baseline to Week 26 and Week 52, Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively., Baseline, Week 26, Week 52
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 507
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-10
Completion Date: 2016-07
Results First Posted: 2018-01-18
Last Update Posted: 2018-01-18
Locations: Investigational Site Number 840049, Tucson, Arizona, 85714, United States|Investigational Site Number 840016, Bell Gardens, California, 90201, United States|Investigational Site Number 840048, Chula Vista, California, 91910, United States|Investigational Site Number 840046, Concord, California, 94520, United States|Investigational Site Number 840039, Fresno, California, 93720, United States|Investigational Site Number 840028, La Jolla, California, 92037, United States|Investigational Site Number 840022, Ventura, California, 93003, United States|Investigational Site Number 840003, Denver, Colorado, 80209, United States|Investigational Site Number 840037, Denver, Colorado, 80262, United States|Investigational Site Number 840005, Bradenton, Florida, 34208, United States|Investigational Site Number 840061, Miami Lakes, Florida, 33014, United States|Investigational Site Number 840057, Miami Lakes, Florida, 33016, United States|Investigational Site Number 840050, Miami, Florida, 33155, United States|Investigational Site Number 840042, Miami, Florida, 33176, United States|Investigational Site Number 840006, New Port Richey, Florida, 34652, United States|Investigational Site Number 840013, North Miami Beach, Florida, 33162, United States|Investigational Site Number 840031, Port Charlotte, Florida, 33952, United States|Investigational Site Number 840036, Atlanta, Georgia, 30318, United States|Investigational Site Number 840045, Roswell, Georgia, 30076, United States|Investigational Site Number 840020, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840019, Chicago, Illinois, 60607, United States|Investigational Site Number 840033, Chicago, Illinois, 60612, United States|Investigational Site Number 840012, McHenry, Illinois, 60050, United States|Investigational Site Number 840004, Des Moines, Iowa, 50314, United States|Investigational Site Number 840043, Marrero, Louisiana, 70072, United States|Investigational Site Number 840021, Metairie, Louisiana, 70006, United States|Investigational Site Number 840038, Baltimore, Maryland, 21237, United States|Investigational Site Number 840014, Rockville, Maryland, 20852, United States|Investigational Site Number 840060, Great Falls, Montana, 59405, United States|Investigational Site Number 840026, Omaha, Nebraska, 68114, United States|Investigational Site Number 840040, Omaha, Nebraska, 68131, United States|Investigational Site Number 840015, Albuquerque, New Mexico, 87106, United States|Investigational Site Number 840054, Albuquerque, New Mexico, 87109, United States|Investigational Site Number 840059, Mineola, New York, 11501, United States|Investigational Site Number 840030, Burlington, North Carolina, 27215, United States|Investigational Site Number 840051, Greenville, North Carolina, 27834, United States|Investigational Site Number 840062, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840018, Gallipolis, Ohio, 45631, United States|Investigational Site Number 840007, Dakota Dunes, South Dakota, 57049, United States|Investigational Site Number 840027, Rapid City, South Dakota, 57701, United States|Investigational Site Number 840041, Dallas, Texas, 75230, United States|Investigational Site Number 840029, Dallas, Texas, 75231, United States|Investigational Site Number 840034, Dallas, Texas, 75246, United States|Investigational Site Number 840002, Houston, Texas, 77090, United States|Investigational Site Number 840011, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840023, Tacoma, Washington, 98415-0299, United States|Investigational Site Number 840009, Milwaukee, Wisconsin, 53209-0996, United States|Investigational Site Number 250002, Corbeil Essonnes, 91100, France|Investigational Site Number 250005, Mantes La Jolie, 78200, France|Investigational Site Number 250003, Montpellier Cedex 5, 34295, France|Investigational Site Number 250001, Vandoeuvre Les Nancy, 54511, France|Investigational Site Number 276001, Berlin, 10115, Germany|Investigational Site Number 276004, Dortmund, 44137, Germany|Investigational Site Number 276006, Hannover, 30159, Germany|Investigational Site Number 276002, Heidelberg, 69115, Germany|Investigational Site Number 276003, Neumünster, 24534, Germany|Investigational Site Number 276008, Pirna, 01796, Germany|Investigational Site Number 276007, Potsdam, 14469, Germany|Investigational Site Number 276005, Sulzbach-Rosenberg, 92237, Germany|Investigational Site Number 348002, Budapest, 1023, Hungary|Investigational Site Number 348005, Budapest, 1033, Hungary|Investigational Site Number 348003, Budapest, 1062, Hungary|Investigational Site Number 348011, Budapest, 1062, Hungary|Investigational Site Number 348010, Budapest, 1139, Hungary|Investigational Site Number 348001, Budapest, 1213, Hungary|Investigational Site Number 348007, Debrecen, 4031, Hungary|Investigational Site Number 392006, Chuo-Ku, Japan|Investigational Site Number 392003, Higashiosaka-Shi, Japan|Investigational Site Number 392004, Izumisano-Shi, Japan|Investigational Site Number 392005, Kamakura-Shi, Japan|Investigational Site Number 392001, Shinjuku-Ku, Japan|Investigational Site Number 392002, Yamato-Shi, Japan|Investigational Site Number 616005, Krakow, 31-501, Poland|Investigational Site Number 616001, Poznan, 60-834, Poland|Investigational Site Number 616003, Szczecin, 70-506, Poland|Investigational Site Number 616002, Warszawa, 02-507, Poland|Investigational Site Number 616004, Zabrze, 41-800, Poland|Investigational Site Number 643003, Moscow, 117036, Russian Federation|Investigational Site Number 643006, Samara, 443041, Russian Federation|Investigational Site Number 643002, Saratov, 410030, Russian Federation|Investigational Site Number 643004, St-Petersburg, 190068, Russian Federation|Investigational Site Number 643001, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643005, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643007, Tomsk, 634050, Russian Federation|Investigational Site Number 724002, A Coruña, 15006, Spain|Investigational Site Number 724001, Cáceres, 10003, Spain|Investigational Site Number 724004, Lérida, 25198, Spain|Investigational Site Number 724005, Málaga, 29010, Spain|Investigational Site Number 724003, Sabadell, 08208, Spain
URL: https://clinicaltrials.gov/show/NCT02273180

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress