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Trial record 1 of 1 for:    LPS14354
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02642159
Recruitment Status : Completed
First Posted : December 30, 2015
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy.

Secondary Objectives:

  • To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number).
  • To assess changes in glycemic parameters with alirocumab vs. usual care treatment.
  • To demonstrate the safety and tolerability of alirocumab.
  • To evaluate treatment acceptance of alirocumab.
  • To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development.
  • To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Alirocumab Drug: Statins Drug: Ezetimibe Drug: Fenofibrate Drug: Nicotinic acid Drug: Omega-3 fatty acids Drug: Antihyperglycemic Drug Phase 4

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.

For the purpose of scientific communication, a first-step analysis (both efficacy and safety) was performed at the Week 24 cut-off date. A second-step analysis was performed once all participants had completed the study to include a final update of the safety analysis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin Therapy
Study Start Date : March 15, 2016
Actual Primary Completion Date : March 22, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

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 insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapy (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels >=100 mg/dL (2.59 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: Statins
Statins at stable dose without other LMT as clinically indicated.

Drug: Antihyperglycemic Drug
Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.

Active Comparator: Usual Care
Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.
Drug: Statins
Statins at stable dose without other LMT as clinically indicated.

Drug: Ezetimibe
Pharmaceutical form: tablet Route of administration: oral

Drug: Fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: Nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Drug: Omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: Antihyperglycemic Drug
Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.




Primary Outcome Measures :
  1. Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis [ Time Frame: From Baseline to Week 24 ]
    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).

  2. Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  2. Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  3. Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  4. Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  5. Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  6. Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  7. Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  8. Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  9. Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  10. Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  11. Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  12. Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  13. Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  14. Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  15. Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  16. Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  17. Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis [ Time Frame: From Baseline to Week 24 ]
    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.

  18. Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [ Time Frame: From Baseline to Week 24 ]
    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.

  19. Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis [ Time Frame: Baseline, Week 12 and 24 ]
    Absolute change = HbA1c value at specified week minus HbA1c value at baseline.

  20. Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis [ Time Frame: Baseline, Week 12 and 24 ]
    Absolute change = FPG value at specified week minus FPG value at baseline.

  21. Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis [ Time Frame: Baseline, Week 12 and 24 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.
  • 18 years of age or more.
  • Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
  • Non-HDL-C of 100 mg/dL or greater.
  • Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
  • Stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).
  • No change in weight of more than 5 kg within the prior 3 months.
  • On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.

Exclusion criteria:

  • Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.
  • Currently drinking more than 2 standard alcoholic drinks per day.
  • Body Mass Index (BMI) >45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.
  • Glycosylated hemoglobin (HbA1c) 9% or greater.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642159


  Hide Study Locations
Locations
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United States, Arkansas
Investigational Site Number 840-163
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840-141
Fresno, California, United States, 93720
Investigational Site Number 840-152
Huntington Beach, California, United States, 92648
Investigational Site Number 840-115
La Jolla, California, United States, 92037
Investigational Site Number 840-118
Los Angeles, California, United States, 90057
Investigational Site Number 840-106
Northridge, California, United States, 91325
Investigational Site Number 840-176
Port Hueneme, California, United States, 93041
Investigational Site Number 840-122
Tarzana, California, United States, 91356
Investigational Site Number 840-156
Tustin, California, United States, 92780-6953
Investigational Site Number 840-160
Van Nuys, California, United States, 91405
United States, Florida
Investigational Site Number 840-107
Boca Raton, Florida, United States, 33434
Investigational Site Number 840-170
Boynton Beach, Florida, United States, 33472
Investigational Site Number 840-114
Bradenton, Florida, United States, 34201
Investigational Site Number 840-132
Ocoee, Florida, United States, 34761
Investigational Site Number 840-179
Oviedo, Florida, United States, 32765
Investigational Site Number 840-123
Tampa, Florida, United States, 33634
United States, Georgia
Investigational Site Number 840-137
Bainbridge, Georgia, United States, 39819
Investigational Site Number 840-128
Columbus, Georgia, United States, 31904
Investigational Site Number 840-169
Stockbridge, Georgia, United States, 30281
United States, Idaho
Investigational Site Number 840-167
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site Number 840-161
Chicago, Illinois, United States, 60607
Investigational Site Number 840-184
Crystal Lake, Illinois, United States, 60012
Investigational Site Number 840-174
Evanston, Illinois, United States, 60201
Investigational Site Number 840-138
Springfield, Illinois, United States, 62711
United States, Kentucky
Investigational Site Number 840-108
Louisville, Kentucky, United States
Investigational Site Number 840-183
Paducah, Kentucky, United States, 42003
United States, Louisiana
Investigational Site Number 840-190
Metairie, Louisiana, United States, 70006
United States, Maryland
Investigational Site Number 840-151
Rockville, Maryland, United States, 20852
United States, Missouri
Investigational Site Number 840-113
Jefferson City, Missouri, United States, 65109
Investigational Site Number 840-120
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Investigational Site Number 840-148
Omaha, Nebraska, United States, 68131-2137
United States, Nevada
Investigational Site Number 840-101
Las Vegas, Nevada, United States, 89119
Investigational Site Number 840-140
Las Vegas, Nevada, United States, 89128
United States, New York
Investigational Site Number 840-178
Albany, New York, United States, 12206
Investigational Site Number 840-181
New York, New York, United States, 10016
Investigational Site Number 840-157
New York, New York, United States, 10029
United States, North Carolina
Investigational Site Number 840-188
Greensboro, North Carolina, United States, 27408
Investigational Site Number 840-131
Morehead City, North Carolina, United States, 28557
Investigational Site Number 840-158
Morganton, North Carolina, United States, 28655
United States, North Dakota
Investigational Site Number 840-129
Fargo, North Dakota, United States, 58103
United States, Ohio
Investigational Site Number 840-104
Columbus, Ohio, United States, 43213
Investigational Site Number 840-105
Marion, Ohio, United States, 43302
Investigational Site Number 840-175
Maumee, Ohio, United States, 43537
United States, Oregon
Investigational Site Number 840-136
Bend, Oregon, United States, 97702
United States, South Carolina
Investigational Site Number 840-187
Murrells Inlet, South Carolina, United States, 29576-9351
Investigational Site Number 840-111
Summerville, South Carolina, United States, 29485
United States, Tennessee
Investigational Site Number 840-147
Chattanooga, Tennessee, United States, 37404
Investigational Site Number 840-159
Knoxville, Tennessee, United States, 37920
United States, Texas
Investigational Site Number 840-153
Dallas, Texas, United States, 75230
Investigational Site Number 840-143
Houston, Texas, United States, 77095
Investigational Site Number 840-168
Houston, Texas, United States, 77099
Investigational Site Number 840-142
Round Rock, Texas, United States, 78681
Investigational Site Number 840-133
Tomball, Texas, United States, 77375
United States, Utah
Investigational Site Number 840-185
Orem, Utah, United States, 84058
Investigational Site Number 840-150
Salt Lake City, Utah, United States, 84102
United States, Virginia
Investigational Site Number 840-126
Chesapeake, Virginia, United States, 23321
Investigational Site Number 840-171
Richmond, Virginia, United States, 23249
Australia
Investigational Site Number 036102
Herston, Australia, 4006
Investigational Site Number 036104
Merewether, Australia, 2291
Investigational Site Number 036101
St Leonards, Australia, 2065
Brazil
Investigational Site Number 076103
Campinas, Brazil, 13060080
Investigational Site Number 076104
Fortaleza, Brazil, 60115-282
Investigational Site Number 076101
Sao Paulo, Brazil, 04040-001
Investigational Site Number 076105
São paulo, Brazil, 01223-001
Investigational Site Number 076106
São Paulo, Brazil, 05403-900
Investigational Site Number 076102
SãO Paulo, Brazil
Finland
Investigational Site Number 246102
Oulu, Finland, 90100
Investigational Site Number 246101
Oulu, Finland, 90220
Investigational Site Number 246104
Tampere, Finland, 33520
Germany
Investigational Site Number 276112
Berlin, Germany, 13347
Investigational Site Number 276109
Berlin, Germany, 13353
Investigational Site Number 276104
Dippoldiswalde, Germany, 01744
Investigational Site Number 276101
Dresden, Germany, 01307
Investigational Site Number 276110
Essen, Germany, 45355
Investigational Site Number 276108
Essen, Germany, 45359
Investigational Site Number 276111
Goch, Germany, 47574
Investigational Site Number 276107
Karlsruhe, Germany, 76199
Investigational Site Number 276103
Künzing, Germany, 94550
Investigational Site Number 276102
Oldenburg in Holstein, Germany, 23758
Israel
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
Italy
Investigational Site Number 380104
Bergamo, Italy, 24127
Investigational Site Number 380107
Catanzaro, Italy, 88100
Investigational Site Number 380103
Napoli, Italy, 80131
Investigational Site Number 380108
Padova, Italy, 35100
Investigational Site Number 380106
Partinico, Italy, 90047
Investigational Site Number 380101
Pisa, Italy, 56124
Investigational Site Number 380105
Roma, Italy, 00168
Investigational Site Number 380102
Torino, Italy, 10126
Kuwait
Investigational Site Number 414101
Kuwait, Kuwait
Lebanon
Investigational Site Number 422101
Beirut, Lebanon
Investigational Site Number 422102
Hazmieh, Lebanon
Norway
Investigational Site Number 578101
Oslo, Norway, 0372
Investigational Site Number 578102
Oslo, Norway, 0407
Sweden
Investigational Site Number 752102
Göteborg, Sweden, 41345
Investigational Site Number 752101
Stockholm, Sweden, 14186
Switzerland
Investigational Site Number 756101
Genève, Switzerland, 1205
Investigational Site Number 756102
Olten, Switzerland, 4600
Investigational Site Number 756103
Reinach, Switzerland, 4153
Turkey
Investigational Site Number 792105
Adana, Turkey, 01250
Investigational Site Number 792106
Ankara, Turkey, 06100
Investigational Site Number 792102
Ankara, Turkey
Investigational Site Number 792108
Corum, Turkey
Investigational Site Number 792109
Hatay, Turkey, 31030
Investigational Site Number 792104
Izmir, Turkey, 35340
Investigational Site Number 792101
Izmir, Turkey
Investigational Site Number 792110
Izmir, Turkey
Investigational Site Number 792107
Kayseri, Turkey, 38039
Investigational Site Number 792103
Samsun, Turkey
United Arab Emirates
Investigational Site Number 784101
Dubai, United Arab Emirates, 4545
United Kingdom
Investigational Site Number 826104
Exeter, United Kingdom, EX25DW
Investigational Site Number 826106
Manchester, United Kingdom, m139wl
Investigational Site Number 826105
Middlesborough, United Kingdom, TS4 3BW
Investigational Site Number 826103
Stevenage, United Kingdom, SG14AB
Investigational Site Number 826101
Torquay, United Kingdom, TQ27AA
Investigational Site Number 826102
West Bromwich, United Kingdom, B714HJ
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] November 18, 2015
Statistical Analysis Plan  [PDF] April 26, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02642159     History of Changes
Other Study ID Numbers: LPS14354
2015-001934-19 ( EudraCT Number )
U1111-1172-5262 ( Other Identifier: UTN )
First Posted: December 30, 2015    Key Record Dates
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Niacin
Niacinamide
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ezetimibe
Fenofibrate
Hypoglycemic Agents
Antibodies, Monoclonal
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Vasodilator Agents