AzTrials
AzTrials

DyslipidemiaPhase 4NCT02642159

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 Phase 4 study testing Alirocumab, Statins and Ezetimibe in people with Dyslipidemia, run by Sanofi at 119 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyslipidemia
What is being tested?
Alirocumab, Statins and Ezetimibe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
119 sitesin 15 countries
Study dates
15 Mar 2016to 15 May 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

119 sites in 15 countries.

119 sites in 15 countries

United States57 sites

  • Investigational Site Number 840-178

    Albany, New York, 12206

  • Investigational Site Number 840-137

    Bainbridge, Georgia, 39819

  • Investigational Site Number 840-136

    Bend, Oregon, 97702

  • Investigational Site Number 840-107

    Boca Raton, Florida, 33434

  • Investigational Site Number 840-170

    Boynton Beach, Florida, 33472

  • Investigational Site Number 840-114

    Bradenton, Florida, 34201

  • Investigational Site Number 840-147

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840-126

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840-161

    Chicago, Illinois, 60607

  • Investigational Site Number 840-128

    Columbus, Georgia, 31904

  • Investigational Site Number 840-104

    Columbus, Ohio, 43213

  • Investigational Site Number 840-184

    Crystal Lake, Illinois, 60012

  • Investigational Site Number 840-153

    Dallas, Texas, 75230

  • Investigational Site Number 840-174

    Evanston, Illinois, 60201

  • Investigational Site Number 840-129

    Fargo, North Dakota, 58103

  • Investigational Site Number 840-141

    Fresno, California, 93720

  • Investigational Site Number 840-188

    Greensboro, North Carolina, 27408

  • Investigational Site Number 840-143

    Houston, Texas, 77095

  • Investigational Site Number 840-168

    Houston, Texas, 77099

  • Investigational Site Number 840-152

    Huntington Beach, California, 92648

  • Investigational Site Number 840-167

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840-113

    Jefferson City, Missouri, 65109

  • Investigational Site Number 840-159

    Knoxville, Tennessee, 37920

  • Investigational Site Number 840-115

    La Jolla, California, 92037

  • Investigational Site Number 840-101

    Las Vegas, Nevada, 89119

  • Investigational Site Number 840-140

    Las Vegas, Nevada, 89128

  • Investigational Site Number 840-163

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840-118

    Los Angeles, California, 90057

  • Investigational Site Number 840-108

    Louisville, Kentucky

  • Investigational Site Number 840-105

    Marion, Ohio, 43302

  • Investigational Site Number 840-175

    Maumee, Ohio, 43537

  • Investigational Site Number 840-190

    Metairie, Louisiana, 70006

  • Investigational Site Number 840-131

    Morehead City, North Carolina, 28557

  • Investigational Site Number 840-158

    Morganton, North Carolina, 28655

  • Investigational Site Number 840-187

    Murrells Inlet, South Carolina, 29576-9351

  • Investigational Site Number 840-181

    New York, New York, 10016

  • Investigational Site Number 840-157

    New York, New York, 10029

  • Investigational Site Number 840-106

    Northridge, California, 91325

  • Investigational Site Number 840-132

    Ocoee, Florida, 34761

  • Investigational Site Number 840-148

    Omaha, Nebraska, 68131-2137

  • Investigational Site Number 840-185

    Orem, Utah, 84058

  • Investigational Site Number 840-179

    Oviedo, Florida, 32765

  • Investigational Site Number 840-183

    Paducah, Kentucky, 42003

  • Investigational Site Number 840-176

    Port Hueneme, California, 93041

  • Investigational Site Number 840-171

    Richmond, Virginia, 23249

  • Investigational Site Number 840-151

    Rockville, Maryland, 20852

  • Investigational Site Number 840-142

    Round Rock, Texas, 78681

  • Investigational Site Number 840-150

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840-138

    Springfield, Illinois, 62711

  • Investigational Site Number 840-120

    St Louis, Missouri, 63110

  • Investigational Site Number 840-169

    Stockbridge, Georgia, 30281

  • Investigational Site Number 840-111

    Summerville, South Carolina, 29485

  • Investigational Site Number 840-123

    Tampa, Florida, 33634

  • Investigational Site Number 840-122

    Tarzana, California, 91356

  • Investigational Site Number 840-133

    Tomball, Texas, 77375

  • Investigational Site Number 840-156

    Tustin, California, 92780-6953

  • Investigational Site Number 840-160

    Van Nuys, California, 91405

Other trials in United States

Germany10 sites

  • Investigational Site Number 276112

    Berlin, 13347

  • Investigational Site Number 276109

    Berlin, 13353

  • Investigational Site Number 276104

    Dippoldiswalde, 01744

  • Investigational Site Number 276101

    Dresden, 01307

  • Investigational Site Number 276110

    Essen, 45355

  • Investigational Site Number 276108

    Essen, 45359

  • Investigational Site Number 276111

    Goch, 47574

  • Investigational Site Number 276107

    Karlsruhe, 76199

  • Investigational Site Number 276103

    Künzing, 94550

  • Investigational Site Number 276102

    Oldenburg in Holstein, 23758

Other trials in Germany

Turkey (Türkiye)10 sites

  • Investigational Site Number 792105

    Adana, 01250

  • Investigational Site Number 792106

    Ankara, 06100

  • Investigational Site Number 792102

    Ankara

  • Investigational Site Number 792108

    Çorum

  • Investigational Site Number 792109

    Hatay, 31030

  • Investigational Site Number 792104

    Izmir, 35340

  • Investigational Site Number 792101

    Izmir

  • Investigational Site Number 792110

    Izmir

  • Investigational Site Number 792107

    Kayseri, 38039

  • Investigational Site Number 792103

    Samsun

Other trials in Turkey (Türkiye)

Italy8 sites

  • Investigational Site Number 380104

    Bergamo, 24127

  • Investigational Site Number 380107

    Catanzaro, 88100

  • Investigational Site Number 380103

    Naples, 80131

  • Investigational Site Number 380108

    Padova, 35100

  • Investigational Site Number 380106

    Partinico, 90047

  • Investigational Site Number 380101

    Pisa, 56124

  • Investigational Site Number 380105

    Roma, 00168

  • Investigational Site Number 380102

    Torino, 10126

Other trials in Italy

Brazil6 sites

  • Investigational Site Number 076103

    Campinas, 13060080

  • Investigational Site Number 076104

    Fortaleza, 60115-282

  • Investigational Site Number 076105

    São Paulo, 01223-001

  • Investigational Site Number 076101

    São Paulo, 04040-001

  • Investigational Site Number 076106

    São Paulo, 05403-900

  • Investigational Site Number 076102

    São Paulo

Other trials in Brazil

United Kingdom6 sites

  • Investigational Site Number 826104

    Exeter, EX25DW

  • Investigational Site Number 826106

    Manchester, m139wl

  • Investigational Site Number 826105

    Middlesbrough, TS4 3BW

  • Investigational Site Number 826103

    Stevenage, SG14AB

  • Investigational Site Number 826101

    Torquay, TQ27AA

  • Investigational Site Number 826102

    West Bromwich, B714HJ

Other trials in United Kingdom

Israel5 sites

  • Investigational Site Number 376101

    Beersheba

  • Investigational Site Number 376103

    Petah Tikva

  • Investigational Site Number 376104

    Petah Tikva

  • Investigational Site Number 376102

    Rehovot

  • Investigational Site Number 376106

    Tel Aviv

Other trials in Israel

Australia3 sites

  • Investigational Site Number 036102

    Herston, 4006

  • Investigational Site Number 036104

    Merewether, 2291

  • Investigational Site Number 036101

    St Leonards, 2065

Other trials in Australia

Finland3 sites

  • Investigational Site Number 246102

    Oulu, 90100

  • Investigational Site Number 246101

    Oulu, 90220

  • Investigational Site Number 246104

    Tampere, 33520

Other trials in Finland

Switzerland3 sites

  • Investigational Site Number 756101

    Geneva, 1205

  • Investigational Site Number 756102

    Olten, 4600

  • Investigational Site Number 756103

    Reinach, 4153

Other trials in Switzerland

Lebanon2 sites

  • Investigational Site Number 422101

    Beirut

  • Investigational Site Number 422102

    Hazmiyeh

Other trials in Lebanon

Norway2 sites

  • Investigational Site Number 578101

    Oslo, 0372

  • Investigational Site Number 578102

    Oslo, 0407

Other trials in Norway

Sweden2 sites

  • Investigational Site Number 752102

    Gothenburg, 41345

  • Investigational Site Number 752101

    Stockholm, 14186

Other trials in Sweden

Kuwait1 site

  • Investigational Site Number 414101

    Kuwait City

Other trials in Kuwait

United Arab Emirates1 site

  • Investigational Site Number 784101

    Dubai, 4545

Other trials in United Arab Emirates

About this study

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

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.

Read more

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).
Read the 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.

Conditions
Dyslipidemia
Being tested
Alirocumab, Statins, Ezetimibe, Fenofibrate, Nicotinic acid
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlirocumabDrug

    Also called SAR236553, REGN727, Praluent

    Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

  • StatinsDrug

    Statins at stable dose without other LMT as clinically indicated.

  • EzetimibeDrug

    Pharmaceutical form: tablet Route of administration: oral

  • FenofibrateDrug

    Pharmaceutical form: tablet Route of administration: oral

  • Nicotinic acidDrug

    Pharmaceutical form: tablet Route of administration: oral

  • Omega-3 fatty acidsDrug

    Pharmaceutical form: tablet Route of administration: oral

  • Antihyperglycemic DrugDrug

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

Study groups in NCT02642159
Study groupRoleWhat they receive
Alirocumab 75 mg Q2W/Up to 150 mg Q2WExperimentalAlirocumab 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.
Receives: Drug: Alirocumab; Drug: Statins; Drug: Antihyperglycemic Drug
Usual CareActive comparatorParticipants 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.
Receives: Drug: Statins; Drug: Ezetimibe; Drug: Fenofibrate; Drug: Nicotinic acid; Drug: Omega-3 fatty acids; Drug: Antihyperglycemic Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From Baseline to Week 24

  2. 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.

    Measured: From Baseline to Week 24

Secondary outcomes (21)

  1. 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.

    Measured: From Baseline to Week 24

  2. 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.

    Measured: From Baseline to Week 24

  3. 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.

    Measured: From Baseline to Week 24

  4. 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.

    Measured: From Baseline to Week 24

  5. 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.

    Measured: From Baseline to Week 24

  6. 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.

    Measured: From Baseline to Week 24

  7. 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.

    Measured: From Baseline to Week 24

  8. 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.

    Measured: From Baseline to Week 24

  9. 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.

    Measured: From Baseline to Week 24

  10. 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.

    Measured: From Baseline to Week 24

  11. 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.

    Measured: From Baseline to Week 24

  12. 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.

    Measured: From Baseline to Week 24

  13. 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.

    Measured: From Baseline to Week 24

  14. 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.

    Measured: From Baseline to Week 24

  15. 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.

    Measured: From Baseline to Week 24

  16. 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.

    Measured: From Baseline to Week 24

  17. 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.

    Measured: From Baseline to Week 24

  18. 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.

    Measured: From Baseline to Week 24

  19. 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.

    Measured: Baseline, Week 12 and 24

  20. 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.

    Measured: Baseline, Week 12 and 24

  21. 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.

    Measured: Baseline, Week 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2015 (estimated)
  2. Study start15 Mar 2016
  3. Primary completion22 Mar 2017
  4. Study completion15 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02642159
Sponsor's protocol ID
LPS14354
Other IDs
2015-001934-19, U1111-1172-5262, 2015
Status last verified
Mar 2018
First submitted
24 Dec 2015
Last updated
1 May 2018
Data monitoring committee
No

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.

    PubMed 33078867

  • 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.

    PubMed 32035487

  • 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.

    PubMed 31706300

  • 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.

    PubMed 29436756

  • 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.

    PubMed 28545518

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alirocumab, Statins and Ezetimibe in people with Dyslipidemia, run by Sanofi at 119 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Germany, Turkey (Türkiye), Italy, Brazil and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis (time frame: From Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02642159, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.

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