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)

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

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).

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Alirocumab; Drug: Statins; Drug: Antihyperglycemic Drug; Drug: Ezetimibe; Drug: Fenofibrate; Drug: Nicotinic acid; Drug: Omega-3 fatty acids

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.

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Herston, Australia, 4006
    • Investigational Site Number 036102
  • Merewether, Australia, 2291
    • Investigational Site Number 036104
  • St Leonards, Australia, 2065
    • Investigational Site Number 036101
• Brazil
  • Campinas, Brazil, 13060080
    • Investigational Site Number 076103
  • Fortaleza, Brazil, 60115-282
    • Investigational Site Number 076104
  • Sao Paulo, Brazil, 04040-001
    • Investigational Site Number 076101
  • SãO Paulo, Brazil
    • Investigational Site Number 076102
  • São Paulo, Brazil, 05403-900
    • Investigational Site Number 076106
  • São paulo, Brazil, 01223-001
    • Investigational Site Number 076105
• Finland
  • Oulu, Finland, 90100
    • Investigational Site Number 246102
  • Oulu, Finland, 90220
    • Investigational Site Number 246101
  • Tampere, Finland, 33520
    • Investigational Site Number 246104
• Germany
  • Berlin, Germany, 13347
    • Investigational Site Number 276112
  • Berlin, Germany, 13353
    • Investigational Site Number 276109
  • Dippoldiswalde, Germany, 01744
    • Investigational Site Number 276104
  • Dresden, Germany, 01307
    • Investigational Site Number 276101
  • Essen, Germany, 45355
    • Investigational Site Number 276110
  • Essen, Germany, 45359
    • Investigational Site Number 276108
  • Goch, Germany, 47574
    • Investigational Site Number 276111
  • Karlsruhe, Germany, 76199
    • Investigational Site Number 276107
  • Künzing, Germany, 94550
    • Investigational Site Number 276103
  • Oldenburg in Holstein, Germany, 23758
    • Investigational Site Number 276102
• Israel
  • Beer Sheva, Israel
    • Investigational Site Number 376101
  • Petach Tikva, Israel
    • Investigational Site Number 376103
  • Petach tikva, Israel
    • Investigational Site Number 376104
  • Rehovot, Israel
    • Investigational Site Number 376102
  • Tel-Aviv, Israel
    • Investigational Site Number 376106
• Italy
  • Bergamo, Italy, 24127
    • Investigational Site Number 380104
  • Catanzaro, Italy, 88100
    • Investigational Site Number 380107
  • Napoli, Italy, 80131
    • Investigational Site Number 380103
  • Padova, Italy, 35100
    • Investigational Site Number 380108
  • Partinico, Italy, 90047
    • Investigational Site Number 380106
  • Pisa, Italy, 56124
    • Investigational Site Number 380101
  • Roma, Italy, 00168
    • Investigational Site Number 380105
  • Torino, Italy, 10126
    • Investigational Site Number 380102
• Kuwait
  • Kuwait, Kuwait
    • Investigational Site Number 414101
• Lebanon
  • Beirut, Lebanon
    • Investigational Site Number 422101
  • Hazmieh, Lebanon
    • Investigational Site Number 422102
• Norway
  • Oslo, Norway, 0372
    • Investigational Site Number 578101
  • Oslo, Norway, 0407
    • Investigational Site Number 578102
• Sweden
  • Göteborg, Sweden, 41345
    • Investigational Site Number 752102
  • Stockholm, Sweden, 14186
    • Investigational Site Number 752101
• Switzerland
  • Genève, Switzerland, 1205
    • Investigational Site Number 756101
  • Olten, Switzerland, 4600
    • Investigational Site Number 756102
  • Reinach, Switzerland, 4153
    • Investigational Site Number 756103
• Turkey
  • Adana, Turkey, 01250
    • Investigational Site Number 792105
  • Ankara, Turkey, 06100
    • Investigational Site Number 792106
  • Ankara, Turkey
    • Investigational Site Number 792102
  • Corum, Turkey
    • Investigational Site Number 792108
  • Hatay, Turkey, 31030
    • Investigational Site Number 792109
  • Izmir, Turkey, 35340
    • Investigational Site Number 792104
  • Izmir, Turkey
    • Investigational Site Number 792101
  • Izmir, Turkey
    • Investigational Site Number 792110
  • Kayseri, Turkey, 38039
    • Investigational Site Number 792107
  • Samsun, Turkey
    • Investigational Site Number 792103
• United Arab Emirates
  • Dubai, United Arab Emirates, 4545
    • Investigational Site Number 784101
• United Kingdom
  • Exeter, United Kingdom, EX25DW
    • Investigational Site Number 826104
  • Manchester, United Kingdom, m139wl
    • Investigational Site Number 826106
  • Middlesborough, United Kingdom, TS4 3BW
    • Investigational Site Number 826105
  • Stevenage, United Kingdom, SG14AB
    • Investigational Site Number 826103
  • Torquay, United Kingdom, TQ27AA
    • Investigational Site Number 826101
  • West Bromwich, United Kingdom, B714HJ
    • Investigational Site Number 826102
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Investigational Site Number 840-163
  • California
    • Fresno, California, United States, 93720
      • Investigational Site Number 840-141
    • Huntington Beach, California, United States, 92648
      • Investigational Site Number 840-152
    • La Jolla, California, United States, 92037
      • Investigational Site Number 840-115
    • Los Angeles, California, United States, 90057
      • Investigational Site Number 840-118
    • Northridge, California, United States, 91325
      • Investigational Site Number 840-106
    • Port Hueneme, California, United States, 93041
      • Investigational Site Number 840-176
    • Tarzana, California, United States, 91356
      • Investigational Site Number 840-122
    • Tustin, California, United States, 92780-6953
      • Investigational Site Number 840-156
    • Van Nuys, California, United States, 91405
      • Investigational Site Number 840-160
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Investigational Site Number 840-107
    • Boynton Beach, Florida, United States, 33472
      • Investigational Site Number 840-170
    • Bradenton, Florida, United States, 34201
      • Investigational Site Number 840-114
    • Ocoee, Florida, United States, 34761
      • Investigational Site Number 840-132
    • Oviedo, Florida, United States, 32765
      • Investigational Site Number 840-179
    • Tampa, Florida, United States, 33634
      • Investigational Site Number 840-123
  • Georgia
    • Bainbridge, Georgia, United States, 39819
      • Investigational Site Number 840-137
    • Columbus, Georgia, United States, 31904
      • Investigational Site Number 840-128
    • Stockbridge, Georgia, United States, 30281
      • Investigational Site Number 840-169
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Investigational Site Number 840-167
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Investigational Site Number 840-161
    • Crystal Lake, Illinois, United States, 60012
      • Investigational Site Number 840-184
    • Evanston, Illinois, United States, 60201
      • Investigational Site Number 840-174
    • Springfield, Illinois, United States, 62711
      • Investigational Site Number 840-138
  • Kentucky
    • Louisville, Kentucky, United States
      • Investigational Site Number 840-108
    • Paducah, Kentucky, United States, 42003
      • Investigational Site Number 840-183
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Investigational Site Number 840-190
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Investigational Site Number 840-151
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Investigational Site Number 840-113
    • Saint Louis, Missouri, United States, 63110
      • Investigational Site Number 840-120
  • Nebraska
    • Omaha, Nebraska, United States, 68131-2137
      • Investigational Site Number 840-148
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Investigational Site Number 840-101
    • Las Vegas, Nevada, United States, 89128
      • Investigational Site Number 840-140
  • New York
    • Albany, New York, United States, 12206
      • Investigational Site Number 840-178
    • New York, New York, United States, 10016
      • Investigational Site Number 840-181
    • New York, New York, United States, 10029
      • Investigational Site Number 840-157
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Investigational Site Number 840-188
    • Morehead City, North Carolina, United States, 28557
      • Investigational Site Number 840-131
    • Morganton, North Carolina, United States, 28655
      • Investigational Site Number 840-158
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Investigational Site Number 840-129
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Investigational Site Number 840-104
    • Marion, Ohio, United States, 43302
      • Investigational Site Number 840-105
    • Maumee, Ohio, United States, 43537
      • Investigational Site Number 840-175
  • Oregon
    • Bend, Oregon, United States, 97702
      • Investigational Site Number 840-136
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576-9351
      • Investigational Site Number 840-187
    • Summerville, South Carolina, United States, 29485
      • Investigational Site Number 840-111
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Investigational Site Number 840-147
    • Knoxville, Tennessee, United States, 37920
      • Investigational Site Number 840-159
  • Texas
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 840-153
    • Houston, Texas, United States, 77095
      • Investigational Site Number 840-143
    • Houston, Texas, United States, 77099
      • Investigational Site Number 840-168
    • Round Rock, Texas, United States, 78681
      • Investigational Site Number 840-142
    • Tomball, Texas, United States, 77375
      • Investigational Site Number 840-133
  • Utah
    • Orem, Utah, United States, 84058
      • Investigational Site Number 840-185
    • Salt Lake City, Utah, United States, 84102
      • Investigational Site Number 840-150
  • Virginia
    • Chesapeake, Virginia, United States, 23321
      • Investigational Site Number 840-126
    • Richmond, Virginia, United States, 23249
      • Investigational Site Number 840-171

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

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 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: Antihyperglycemic Drug; Insulin (injectable or inhaled) or other antihyperglycemic drugs 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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.
• Colhoun HM, Leiter LA, Muller-Wieland D, Cariou B, Ray KK, Tinahones FJ, Domenger C, Letierce A, Israel M, Samuel R, Del Prato S. Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol. Cardiovasc Diabetol. 2020 Feb 8;19(1):14. doi: 10.1186/s12933-020-0991-1.
• Ray KK, Leiter LA, Muller-Wieland D, Cariou B, Colhoun HM, Henry RR, Tinahones FJ, Bujas-Bobanovic M, Domenger C, Letierce A, Samuel R, Del Prato S. Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial. Diabetes Obes Metab. 2018 Jun;20(6):1479-1489. doi: 10.1111/dom.13257. Epub 2018 Mar 23.
• Muller-Wieland D, Leiter LA, Cariou B, Letierce A, Colhoun HM, Del Prato S, Henry RR, Tinahones FJ, Aurand L, Maroni J, Ray KK, Bujas-Bobanovic M. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol. 2017 May 25;16(1):70. doi: 10.1186/s12933-017-0552-4.

Study record dates

Study Major Dates

• Study Start: March 15, 2016
• Primary Completion (Actual): March 22, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 24, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Hypoglycemic Agents; Nicotinic Acids; Fenofibrate; Niacinamide; Niacin; Ezetimibe
• Other Study ID Numbers: LPS14354; 2015-001934-19 (EudraCT Number); U1111-1172-5262 (Other Identifier: UTN)