Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

Primary Objectives:

• To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy.
• To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin.

Secondary Objective:

To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).

Study Overview

• Status: Completed
• Conditions: Hypercholesterolaemia
• Intervention / Treatment: Drug: Alirocumab; Drug: Placebo; Drug: Lipid-Modifying Therapy (LMT); Drug: Antihyperglycemic Drug

Detailed Description

The maximum study duration was approximately 9 months per participant, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period.

• Study Type: Interventional
• Enrollment (Actual): 517
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Investigational Site Number 040002
  • Linz, Austria, 4021
    • Investigational Site Number 040005
  • Salzburg, Austria, 5020
    • Investigational Site Number 040003
  • Salzburg, Austria, 5026
    • Investigational Site Number 040004
  • Wien, Austria, 1160
    • Investigational Site Number 040001
• Belgium
  • Edegem, Belgium, 2650
    • Investigational Site Number 056002
  • Haine-Saint-Paul, Belgium, 7100
    • Investigational Site Number 056003
  • Leuven, Belgium, 3000
    • Investigational Site Number 056001
• France
  • Besancon, France, 25030
    • Investigational Site Number 250-008
  • Corbeil Essonnes, France, 91100
    • Investigational Site Number 250-005
  • La Rochelle Cedex 1, France, 17019
    • Investigational Site Number 250-004
  • Le Creusot, France, 71200
    • Investigational Site Number 250-003
  • Mulhouse, France
    • Investigational Site Number 250-009
  • Nantes cedex 01, France, 44093
    • Investigational Site Number 250-002
  • Paris, France, 75018
    • Investigational Site Number 250-007
  • Strasbourg Cedex 2, France, 67098
    • Investigational Site Number 250-006
  • TOULOUSE Cedex 9, France, 31059
    • Investigational Site Number 250-001
• Germany
  • Aschaffenburg, Germany, 63739
    • Investigational Site Number 276015
  • Berlin, Germany, 10115
    • Investigational Site Number 276002
  • Dortmund, Germany, 44137
    • Investigational Site Number 276011
  • Dresden, Germany, 01307
    • Investigational Site Number 276009
  • Dresden, Germany, 01099
    • Investigational Site Number 276019
  • Dresden, Germany, 01279
    • Investigational Site Number 276014
  • Hamburg, Germany, 20246
    • Investigational Site Number 276021
  • Hamburg, Germany, 22041
    • Investigational Site Number 276018
  • Heidelberg, Germany, 69115
    • Investigational Site Number 276005
  • Lüneburg, Germany, 21339
    • Investigational Site Number 276013
  • Magdeburg, Germany, 39120
    • Investigational Site Number 276022
  • Neumünster, Germany, 24534
    • Investigational Site Number 276008
  • Neuwied, Germany, 56564
    • Investigational Site Number 276017
  • Oldenburg, Germany, 26133
    • Investigational Site Number 276004
  • Pirna, Germany, 01796
    • Investigational Site Number 276003
  • Riesa, Germany, 01587
    • Investigational Site Number 276006
  • Saarlouis, Germany, 66740
    • Investigational Site Number 276010
  • Sulzbach-Rosenberg, Germany, 92237
    • Investigational Site Number 276016
• Italy
  • Catania, Italy, 95122
    • Investigational Site Number 380004
  • Catanzaro, Italy
    • Investigational Site Number 380003
  • Como, Italy, 22100
    • Investigational Site Number 380011
  • Milano, Italy, 20132
    • Investigational Site Number 380006
  • Milano, Italy, 20162
    • Investigational Site Number 380007
  • Moncalieri, Italy, 10024
    • Investigational Site Number 380005
  • Napoli, Italy, 80138
    • Investigational Site Number 380009
  • Padova, Italy
    • Investigational Site Number 380008
  • Palermo, Italy, 90127
    • Investigational Site Number 380002
  • Pisa, Italy, 56124
    • Investigational Site Number 380001
  • Roma, Italy, 00133
    • Investigational Site Number 380010
  • Verona, Italy, 37126
    • Investigational Site Number 380012
• Netherlands
  • Apeldoorn, Netherlands, 7334 DZ
    • Investigational Site Number 528002
  • Groningen, Netherlands
    • Investigational Site Number 528005
  • Hoogeveen, Netherlands, 7909AA
    • Investigational Site Number 528003
  • Rotterdam, Netherlands, 3045PM
    • Investigational Site Number 528001
  • Utrecht, Netherlands
    • Investigational Site Number 528004
• Spain
  • Badalona, Spain, 08915
    • Investigational Site Number 724007
  • Barcelona, Spain, 08025
    • Investigational Site Number 724001
  • Ferrol, Spain, 15405
    • Investigational Site Number 724006
  • Granada, Spain, 18003
    • Investigational Site Number 724013
  • Madrid, Spain, 28040
    • Investigational Site Number 724005
  • Madrid, Spain
    • Investigational Site Number 724004
  • Majadahonda, Spain, 28222
    • Investigational Site Number 724011
  • Málaga, Spain, 29010
    • Investigational Site Number 724008
  • Oviedo, Spain, 33006
    • Investigational Site Number 724014
  • Palma de Mallorca, Spain, 07198
    • Investigational Site Number 724009
  • Pamplona, Spain, 31008
    • Investigational Site Number 724002
  • Sant Joan Despí, Spain, 08970
    • Investigational Site Number 724010
  • Segovia, Spain
    • Investigational Site Number 724012
  • Sevilla, Spain, 41071
    • Investigational Site Number 724003
• Switzerland
  • Olten, Switzerland, 4600
    • Investigational Site Number 756001
  • St. Gallen, Switzerland, 9016
    • Investigational Site Number 756003
• United Kingdom
  • Airdrie, United Kingdom, ML60JS
    • Investigational Site Number 826010
  • Bath, United Kingdom, BA13NG
    • Investigational Site Number 826011
  • Bournemouth, United Kingdom, BH77DW
    • Investigational Site Number 826009
  • Bradford, United Kingdom, BD96RJ
    • Investigational Site Number 826005
  • Bristol, United Kingdom, BS28HW
    • Investigational Site Number 826004
  • Burton On Trent, United Kingdom, DE13 0RB
    • Investigational Site Number 826001
  • Durham, United Kingdom, DH15TW
    • Investigational Site Number 826015
  • High Wycombe, United Kingdom, HP112TT
    • Investigational Site Number 826012
  • Manchester, United Kingdom, M239LT
    • Investigational Site Number 826007
  • Peterborough, United Kingdom, PE39QZ
    • Investigational Site Number 826006
  • Southampton, United Kingdom, SO303JB
    • Investigational Site Number 826003
  • Truro, United Kingdom, TR13LJ
    • Investigational Site Number 826008
  • Welwyn Garden City, United Kingdom, AL74HQ
    • Investigational Site Number 826002
• United States
  • California
    • Encino, California, United States, 91436
      • Investigational Site Number 840020
    • Fresno, California, United States, 93720
      • Investigational Site Number 840002
    • Oakland, California, United States, 94612
      • Investigational Site Number 840029
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Investigational Site Number 840027
  • Florida
    • Atlantis, Florida, United States, 33462
      • Investigational Site Number 840026
    • Bradenton, Florida, United States, 33180
      • Investigational Site Number 840006
    • Jacksonville, Florida, United States, 32205
      • Investigational Site Number 840023
    • Palm Harbor, Florida, United States, 34684
      • Investigational Site Number 840028
    • Ponte Vedra Beach, Florida, United States
      • Investigational Site Number 840022
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Investigational Site Number 840021
  • Illinois
    • Springfield, Illinois, United States, 62704
      • Investigational Site Number 840007
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Investigational Site Number 840011
    • Valparaiso, Indiana, United States, 46383
      • Investigational Site Number 840015
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Investigational Site Number 840010
  • Kentucky
    • Louisville, Kentucky, United States
      • Investigational Site Number 840005
  • Maine
    • Auburn, Maine, United States, 04210
      • Investigational Site Number 840018
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Investigational Site Number 840013
    • Rockville, Maryland, United States, 20852
      • Investigational Site Number 840016
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Investigational Site Number 840004
  • New York
    • Jamaica, New York, United States, 11432
      • Investigational Site Number 840012
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Investigational Site Number 840014
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Investigational Site Number 840009
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Investigational Site Number 840024
  • Texas
    • Austin, Texas, United States, 78756
      • Investigational Site Number 840001
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 840003
    • Dallas, Texas, United States, 75246
      • Investigational Site Number 840019
    • Houston, Texas, United States, 77090
      • Investigational Site Number 840025
  • Utah
    • Ogden, Utah, United States, 84405
      • Investigational Site Number 840017
    • Salt Lake City, Utah, United States, 84102
      • Investigational Site Number 840008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Participants diagnosed with Type 1 or Type 2 diabetes at least one year prior to the screening visit (Week -3).
• Signed written informed consent
• Participants with type 1 or type 2 diabetes treated with insulin whose LDL-C levels were not adequately controlled with maximally tolerated lipid-modifying therapy
• LDL-C of 70 mg/dL or greater
• 18 years of age or more
• Glycosylated hemoglobin (HbA1c) less than 10%
• History of cardiovascular disease (including coronary heart disease [CHD] and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor

Exclusion criteria:

• Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening or from screening to randomization, unless statin intolerant
• Triglycerides >400 mg/dL
• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation
• Currently received or planned to receive renal replacement therapy (for example, hemodialysis)
• Change in weight of more than 5 kilograms within the prior 2 months
• Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or planned to intensify insulin regimen during the study
• Not treated with insulin for at least 6 months
• Planned to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study
• Body mass index (BMI) >45 kg/m² or planned to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study
• History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alirocumab 75 mg Q2W/Up to 150 mg Q2W; Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable, maximally tolerated dose of statin therapy with or without other lipid-modifying therapy (LMT), insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.	Drug: Alirocumab; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.; Other Names: SAR236553; REGN727; Praluent; Drug: Lipid-Modifying Therapy (LMT); Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.; Drug: Antihyperglycemic Drug; Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.
Placebo Comparator: Placebo Q2W; Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.	Drug: Placebo; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.; Drug: Lipid-Modifying Therapy (LMT); Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.; Drug: Antihyperglycemic Drug; Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
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 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 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 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
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 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

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
• Ray KK, Del Prato S, Muller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9.
• Leiter LA, Cariou B, Muller-Wieland D, Colhoun HM, Del Prato S, Tinahones FJ, Ray KK, Bujas-Bobanovic M, Domenger C, Mandel J, Samuel R, Henry RR. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017 Dec;19(12):1781-1792. doi: 10.1111/dom.13114. Epub 2017 Oct 10.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2015
• Primary Completion (Actual): April 3, 2017
• Study Completion (Actual): April 3, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID Numbers: LPS14355; 2015-000799-92 (EudraCT Number); U1111-1172-4772 (Other Identifier: UTN)