Clinical Trial Details
| Trial ID: | L5382 |
| Source ID: | NCT02642159 |
| Associated Drug: | Alirocumab |
| Title: | Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02642159/results |
| Conditions: | Dyslipidemia |
| Interventions: | DRUG: Alirocumab|DRUG: Statins|DRUG: Ezetimibe|DRUG: Fenofibrate|DRUG: Nicotinic acid|DRUG: Omega-3 fatty acids|DRUG: Antihyperglycemic Drug |
| Outcome Measures: | Primary: Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis, Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis)., From Baseline to Week 24|Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24 | Secondary: Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis, Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis, Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis, Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum, Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis, Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model., From Baseline to Week 24|Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis, Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis, LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum, LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate., From Baseline to Week 24|Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis, Absolute change = HbA1c value at specified week minus HbA1c value at baseline., Baseline, Week 12 and 24|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis, Absolute change = FPG value at specified week minus FPG value at baseline., Baseline, Week 12 and 24|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis, Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value., Baseline, Week 12 and 24 |
| Sponsor/Collaborators: | Sponsor: Sanofi | Collaborators: Regeneron Pharmaceuticals |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 413 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-03-15 |
| Completion Date: | 2017-05-15 |
| Results First Posted: | 2018-05-01 |
| Last Update Posted: | 2018-05-01 |
| Locations: | Investigational Site Number 840-163, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840-141, Fresno, California, 93720, United States|Investigational Site Number 840-152, Huntington Beach, California, 92648, United States|Investigational Site Number 840-115, La Jolla, California, 92037, United States|Investigational Site Number 840-118, Los Angeles, California, 90057, United States|Investigational Site Number 840-106, Northridge, California, 91325, United States|Investigational Site Number 840-176, Port Hueneme, California, 93041, United States|Investigational Site Number 840-122, Tarzana, California, 91356, United States|Investigational Site Number 840-156, Tustin, California, 92780-6953, United States|Investigational Site Number 840-160, Van Nuys, California, 91405, United States|Investigational Site Number 840-107, Boca Raton, Florida, 33434, United States|Investigational Site Number 840-170, Boynton Beach, Florida, 33472, United States|Investigational Site Number 840-114, Bradenton, Florida, 34201, United States|Investigational Site Number 840-132, Ocoee, Florida, 34761, United States|Investigational Site Number 840-179, Oviedo, Florida, 32765, United States|Investigational Site Number 840-123, Tampa, Florida, 33634, United States|Investigational Site Number 840-137, Bainbridge, Georgia, 39819, United States|Investigational Site Number 840-128, Columbus, Georgia, 31904, United States|Investigational Site Number 840-169, Stockbridge, Georgia, 30281, United States|Investigational Site Number 840-167, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840-161, Chicago, Illinois, 60607, United States|Investigational Site Number 840-184, Crystal Lake, Illinois, 60012, United States|Investigational Site Number 840-174, Evanston, Illinois, 60201, United States|Investigational Site Number 840-138, Springfield, Illinois, 62711, United States|Investigational Site Number 840-108, Louisville, Kentucky, United States|Investigational Site Number 840-183, Paducah, Kentucky, 42003, United States|Investigational Site Number 840-190, Metairie, Louisiana, 70006, United States|Investigational Site Number 840-151, Rockville, Maryland, 20852, United States|Investigational Site Number 840-113, Jefferson City, Missouri, 65109, United States|Investigational Site Number 840-120, Saint Louis, Missouri, 63110, United States|Investigational Site Number 840-148, Omaha, Nebraska, 68131-2137, United States|Investigational Site Number 840-101, Las Vegas, Nevada, 89119, United States|Investigational Site Number 840-140, Las Vegas, Nevada, 89128, United States|Investigational Site Number 840-178, Albany, New York, 12206, United States|Investigational Site Number 840-181, New York, New York, 10016, United States|Investigational Site Number 840-157, New York, New York, 10029, United States|Investigational Site Number 840-188, Greensboro, North Carolina, 27408, United States|Investigational Site Number 840-131, Morehead City, North Carolina, 28557, United States|Investigational Site Number 840-158, Morganton, North Carolina, 28655, United States|Investigational Site Number 840-129, Fargo, North Dakota, 58103, United States|Investigational Site Number 840-104, Columbus, Ohio, 43213, United States|Investigational Site Number 840-105, Marion, Ohio, 43302, United States|Investigational Site Number 840-175, Maumee, Ohio, 43537, United States|Investigational Site Number 840-136, Bend, Oregon, 97702, United States|Investigational Site Number 840-187, Murrells Inlet, South Carolina, 29576-9351, United States|Investigational Site Number 840-111, Summerville, South Carolina, 29485, United States|Investigational Site Number 840-147, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840-159, Knoxville, Tennessee, 37920, United States|Investigational Site Number 840-153, Dallas, Texas, 75230, United States|Investigational Site Number 840-143, Houston, Texas, 77095, United States|Investigational Site Number 840-168, Houston, Texas, 77099, United States|Investigational Site Number 840-142, Round Rock, Texas, 78681, United States|Investigational Site Number 840-133, Tomball, Texas, 77375, United States|Investigational Site Number 840-185, Orem, Utah, 84058, United States|Investigational Site Number 840-150, Salt Lake City, Utah, 84102, United States|Investigational Site Number 840-126, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840-171, Richmond, Virginia, 23249, United States|Investigational Site Number 036102, Herston, 4006, Australia|Investigational Site Number 036104, Merewether, 2291, Australia|Investigational Site Number 036101, St Leonards, 2065, Australia|Investigational Site Number 076103, Campinas, 13060080, Brazil|Investigational Site Number 076104, Fortaleza, 60115-282, Brazil|Investigational Site Number 076101, Sao Paulo, 04040-001, Brazil|Investigational Site Number 076105, São paulo, 01223-001, Brazil|Investigational Site Number 076106, São Paulo, 05403-900, Brazil|Investigational Site Number 076102, SãO Paulo, Brazil|Investigational Site Number 246102, Oulu, 90100, Finland|Investigational Site Number 246101, Oulu, 90220, Finland|Investigational Site Number 246104, Tampere, 33520, Finland|Investigational Site Number 276112, Berlin, 13347, Germany|Investigational Site Number 276109, Berlin, 13353, Germany|Investigational Site Number 276104, Dippoldiswalde, 01744, Germany|Investigational Site Number 276101, Dresden, 01307, Germany|Investigational Site Number 276110, Essen, 45355, Germany|Investigational Site Number 276108, Essen, 45359, Germany|Investigational Site Number 276111, Goch, 47574, Germany|Investigational Site Number 276107, Karlsruhe, 76199, Germany|Investigational Site Number 276103, Künzing, 94550, Germany|Investigational Site Number 276102, Oldenburg in Holstein, 23758, Germany|Investigational Site Number 376101, Beer Sheva, Israel|Investigational Site Number 376103, Petach Tikva, Israel|Investigational Site Number 376104, Petach tikva, Israel|Investigational Site Number 376102, Rehovot, Israel|Investigational Site Number 376106, Tel-Aviv, Israel|Investigational Site Number 380104, Bergamo, 24127, Italy|Investigational Site Number 380107, Catanzaro, 88100, Italy|Investigational Site Number 380103, Napoli, 80131, Italy|Investigational Site Number 380108, Padova, 35100, Italy|Investigational Site Number 380106, Partinico, 90047, Italy|Investigational Site Number 380101, Pisa, 56124, Italy|Investigational Site Number 380105, Roma, 00168, Italy|Investigational Site Number 380102, Torino, 10126, Italy|Investigational Site Number 414101, Kuwait, Kuwait|Investigational Site Number 422101, Beirut, Lebanon|Investigational Site Number 422102, Hazmieh, Lebanon|Investigational Site Number 578101, Oslo, 0372, Norway|Investigational Site Number 578102, Oslo, 0407, Norway|Investigational Site Number 752102, Göteborg, 41345, Sweden|Investigational Site Number 752101, Stockholm, 14186, Sweden|Investigational Site Number 756101, Genève, 1205, Switzerland|Investigational Site Number 756102, Olten, 4600, Switzerland|Investigational Site Number 756103, Reinach, 4153, Switzerland|Investigational Site Number 792105, Adana, 01250, Turkey|Investigational Site Number 792106, Ankara, 06100, Turkey|Investigational Site Number 792102, Ankara, Turkey|Investigational Site Number 792108, Corum, Turkey|Investigational Site Number 792109, Hatay, 31030, Turkey|Investigational Site Number 792104, Izmir, 35340, Turkey|Investigational Site Number 792101, Izmir, Turkey|Investigational Site Number 792110, Izmir, Turkey|Investigational Site Number 792107, Kayseri, 38039, Turkey|Investigational Site Number 792103, Samsun, Turkey|Investigational Site Number 784101, Dubai, 4545, United Arab Emirates|Investigational Site Number 826104, Exeter, EX25DW, United Kingdom|Investigational Site Number 826106, Manchester, m139wl, United Kingdom|Investigational Site Number 826105, Middlesborough, TS4 3BW, United Kingdom|Investigational Site Number 826103, Stevenage, SG14AB, United Kingdom|Investigational Site Number 826101, Torquay, TQ27AA, United Kingdom|Investigational Site Number 826102, West Bromwich, B714HJ, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT02642159 |
