| Outcome Measures: |
Primary: Percent Change From Baseline in Calculated LDL-C at Week 24 - 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 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis)., From Baseline to Week 24|Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs), Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days)., From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks) | Secondary: Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis, Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection)., From Baseline to Week 24|Percent Change From Baseline in Measured LDL-C at Week 24 - 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 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis, Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 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 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 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis, Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection)., Up to Week 24|Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis, Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach (for T1DM participants) and multiple imputation approach model (for T2DM participants) including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). The maximum likelihood estimate did not exist as response rate was zero in a treatment group of T1DM participants., Up to Week 24|Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis, Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection)., Up to Week 24|Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis, Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection)., Up to Week 24|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis, Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach for handling of missing data followed by robust regression model. All available post-baseline data from Week 4 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 HDL-C at Week 24 - ITT Analysis, Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 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 Analysis, Adjusted means and standard errors at Week 24 from multiple imputation approach for handling of missing data followed by robust regression model including all available post-baseline data from Week 4 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 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 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis, LDL-C particle size was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment., From Baseline to Week 24|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis, Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline., Baseline, Weeks 12 and 24|Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis, Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis, Absolute change = FPG value at specified weeks minus FPG value at baseline., Baseline, Weeks 12 and 24|Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis, Absolute change = FPG value at specified weeks minus FPG value at baseline., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis, Absolute change = total daily insulin dose at specified weeks minus baseline value., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis, Absolute change = total daily insulin dose at specified weeks minus baseline value., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis, Absolute change = daily insulin dose/kg at specified weeks minus baseline value., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis, Absolute change = daily insulin dose/kg at specified weeks minus baseline value., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - 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 weeks minus baseline value., Baseline, Weeks 12 and 24|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment 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 weeks minus baseline value., Baseline, Weeks 12 and 24
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| Locations: |
Investigational Site Number 840020, Encino, California, 91436, United States|Investigational Site Number 840002, Fresno, California, 93720, United States|Investigational Site Number 840029, Oakland, California, 94612, United States|Investigational Site Number 840027, Loveland, Colorado, 80538, United States|Investigational Site Number 840026, Atlantis, Florida, 33462, United States|Investigational Site Number 840006, Bradenton, Florida, 33180, United States|Investigational Site Number 840023, Jacksonville, Florida, 32205, United States|Investigational Site Number 840028, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840022, Ponte Vedra Beach, Florida, United States|Investigational Site Number 840021, Roswell, Georgia, 30076, United States|Investigational Site Number 840007, Springfield, Illinois, 62704, United States|Investigational Site Number 840011, Indianapolis, Indiana, 46260, United States|Investigational Site Number 840015, Valparaiso, Indiana, 46383, United States|Investigational Site Number 840010, Des Moines, Iowa, 50314, United States|Investigational Site Number 840005, Louisville, Kentucky, United States|Investigational Site Number 840018, Auburn, Maine, 04210, United States|Investigational Site Number 840013, Hyattsville, Maryland, 20782, United States|Investigational Site Number 840016, Rockville, Maryland, 20852, United States|Investigational Site Number 840004, Minneapolis, Minnesota, 55416, United States|Investigational Site Number 840012, Jamaica, New York, 11432, United States|Investigational Site Number 840014, Maumee, Ohio, 43537, United States|Investigational Site Number 840009, Greer, South Carolina, 29651, United States|Investigational Site Number 840024, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840001, Austin, Texas, 78756, United States|Investigational Site Number 840003, Dallas, Texas, 75230, United States|Investigational Site Number 840019, Dallas, Texas, 75246, United States|Investigational Site Number 840025, Houston, Texas, 77090, United States|Investigational Site Number 840017, Ogden, Utah, 84405, United States|Investigational Site Number 840008, Salt Lake City, Utah, 84102, United States|Investigational Site Number 040002, Innsbruck, 6020, Austria|Investigational Site Number 040005, Linz, 4021, Austria|Investigational Site Number 040003, Salzburg, 5020, Austria|Investigational Site Number 040004, Salzburg, 5026, Austria|Investigational Site Number 040001, Wien, 1160, Austria|Investigational Site Number 056002, Edegem, 2650, Belgium|Investigational Site Number 056003, Haine-Saint-Paul, 7100, Belgium|Investigational Site Number 056001, Leuven, 3000, Belgium|Investigational Site Number 250-008, Besancon, 25030, France|Investigational Site Number 250-005, Corbeil Essonnes, 91100, France|Investigational Site Number 250-004, La Rochelle Cedex 1, 17019, France|Investigational Site Number 250-003, Le Creusot, 71200, France|Investigational Site Number 250-009, Mulhouse, France|Investigational Site Number 250-002, Nantes cedex 01, 44093, France|Investigational Site Number 250-007, Paris, 75018, France|Investigational Site Number 250-006, Strasbourg Cedex 2, 67098, France|Investigational Site Number 250-001, TOULOUSE Cedex 9, 31059, France|Investigational Site Number 276015, Aschaffenburg, 63739, Germany|Investigational Site Number 276002, Berlin, 10115, Germany|Investigational Site Number 276011, Dortmund, 44137, Germany|Investigational Site Number 276019, Dresden, 01099, Germany|Investigational Site Number 276014, Dresden, 01279, Germany|Investigational Site Number 276009, Dresden, 01307, Germany|Investigational Site Number 276021, Hamburg, 20246, Germany|Investigational Site Number 276018, Hamburg, 22041, Germany|Investigational Site Number 276005, Heidelberg, 69115, Germany|Investigational Site Number 276013, Lüneburg, 21339, Germany|Investigational Site Number 276022, Magdeburg, 39120, Germany|Investigational Site Number 276008, Neumünster, 24534, Germany|Investigational Site Number 276017, Neuwied, 56564, Germany|Investigational Site Number 276004, Oldenburg, 26133, Germany|Investigational Site Number 276003, Pirna, 01796, Germany|Investigational Site Number 276006, Riesa, 01587, Germany|Investigational Site Number 276010, Saarlouis, 66740, Germany|Investigational Site Number 276016, Sulzbach-Rosenberg, 92237, Germany|Investigational Site Number 380004, Catania, 95122, Italy|Investigational Site Number 380003, Catanzaro, Italy|Investigational Site Number 380011, Como, 22100, Italy|Investigational Site Number 380006, Milano, 20132, Italy|Investigational Site Number 380007, Milano, 20162, Italy|Investigational Site Number 380005, Moncalieri, 10024, Italy|Investigational Site Number 380009, Napoli, 80138, Italy|Investigational Site Number 380008, Padova, Italy|Investigational Site Number 380002, Palermo, 90127, Italy|Investigational Site Number 380001, Pisa, 56124, Italy|Investigational Site Number 380010, Roma, 00133, Italy|Investigational Site Number 380012, Verona, 37126, Italy|Investigational Site Number 528002, Apeldoorn, 7334 DZ, Netherlands|Investigational Site Number 528005, Groningen, Netherlands|Investigational Site Number 528003, Hoogeveen, 7909AA, Netherlands|Investigational Site Number 528001, Rotterdam, 3045PM, Netherlands|Investigational Site Number 528004, Utrecht, Netherlands|Investigational Site Number 724007, Badalona, 08915, Spain|Investigational Site Number 724001, Barcelona, 08025, Spain|Investigational Site Number 724006, Ferrol, 15405, Spain|Investigational Site Number 724013, Granada, 18003, Spain|Investigational Site Number 724005, Madrid, 28040, Spain|Investigational Site Number 724004, Madrid, Spain|Investigational Site Number 724011, Majadahonda, 28222, Spain|Investigational Site Number 724008, Málaga, 29010, Spain|Investigational Site Number 724014, Oviedo, 33006, Spain|Investigational Site Number 724009, Palma de Mallorca, 07198, Spain|Investigational Site Number 724002, Pamplona, 31008, Spain|Investigational Site Number 724010, Sant Joan Despí, 08970, Spain|Investigational Site Number 724012, Segovia, Spain|Investigational Site Number 724003, Sevilla, 41071, Spain|Investigational Site Number 756001, Olten, 4600, Switzerland|Investigational Site Number 756003, St. Gallen, 9016, Switzerland|Investigational Site Number 826010, Airdrie, ML60JS, United Kingdom|Investigational Site Number 826011, Bath, BA13NG, United Kingdom|Investigational Site Number 826009, Bournemouth, BH77DW, United Kingdom|Investigational Site Number 826005, Bradford, BD96RJ, United Kingdom|Investigational Site Number 826004, Bristol, BS28HW, United Kingdom|Investigational Site Number 826001, Burton On Trent, DE13 0RB, United Kingdom|Investigational Site Number 826015, Durham, DH15TW, United Kingdom|Investigational Site Number 826012, High Wycombe, HP112TT, United Kingdom|Investigational Site Number 826007, Manchester, M239LT, United Kingdom|Investigational Site Number 826006, Peterborough, PE39QZ, United Kingdom|Investigational Site Number 826003, Southampton, SO303JB, United Kingdom|Investigational Site Number 826008, Truro, TR13LJ, United Kingdom|Investigational Site Number 826002, Welwyn Garden City, AL74HQ, United Kingdom
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