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HypercholesterolaemiaPhase 3NCT02585778

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 Phase 3 study testing Alirocumab, Lipid-Modifying Therapy (LMT) and Antihyperglycemic Drug in people with Hypercholesterolaemia, run by Sanofi at 110 sites in 10 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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolaemia
What is being tested?
Alirocumab, Lipid-Modifying Therapy (LMT) and Antihyperglycemic Drug
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
517 participants
Where
110 sitesin 10 countries
Study dates
23 Oct 2015to 3 Apr 2017
Phase
Phase 3
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 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

110 sites in 10 countries.

110 sites in 10 countries

United States29 sites

  • Investigational Site Number 840026

    Atlantis, Florida, 33462

  • Investigational Site Number 840018

    Auburn, Maine, 04210

  • Investigational Site Number 840001

    Austin, Texas, 78756

  • Investigational Site Number 840006

    Bradenton, Florida, 33180

  • Investigational Site Number 840024

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840003

    Dallas, Texas, 75230

  • Investigational Site Number 840019

    Dallas, Texas, 75246

  • Investigational Site Number 840010

    Des Moines, Iowa, 50314

  • Investigational Site Number 840020

    Encino, California, 91436

  • Investigational Site Number 840002

    Fresno, California, 93720

  • Investigational Site Number 840009

    Greer, South Carolina, 29651

  • Investigational Site Number 840025

    Houston, Texas, 77090

  • Investigational Site Number 840013

    Hyattsville, Maryland, 20782

  • Investigational Site Number 840011

    Indianapolis, Indiana, 46260

  • Investigational Site Number 840023

    Jacksonville, Florida, 32205

  • Investigational Site Number 840012

    Jamaica, New York, 11432

  • Investigational Site Number 840005

    Louisville, Kentucky

  • Investigational Site Number 840027

    Loveland, Colorado, 80538

  • Investigational Site Number 840014

    Maumee, Ohio, 43537

  • Investigational Site Number 840004

    Minneapolis, Minnesota, 55416

  • Investigational Site Number 840029

    Oakland, California, 94612

  • Investigational Site Number 840017

    Ogden, Utah, 84405

  • Investigational Site Number 840028

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840022

    Ponte Vedra Beach, Florida

  • Investigational Site Number 840016

    Rockville, Maryland, 20852

  • Investigational Site Number 840021

    Roswell, Georgia, 30076

  • Investigational Site Number 840008

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840007

    Springfield, Illinois, 62704

  • Investigational Site Number 840015

    Valparaiso, Indiana, 46383

Other trials in United States

Germany18 sites

  • Investigational Site Number 276015

    Aschaffenburg, 63739

  • Investigational Site Number 276002

    Berlin, 10115

  • Investigational Site Number 276011

    Dortmund, 44137

  • Investigational Site Number 276019

    Dresden, 01099

  • Investigational Site Number 276014

    Dresden, 01279

  • Investigational Site Number 276009

    Dresden, 01307

  • Investigational Site Number 276021

    Hamburg, 20246

  • Investigational Site Number 276018

    Hamburg, 22041

  • Investigational Site Number 276005

    Heidelberg, 69115

  • Investigational Site Number 276013

    Lüneburg, 21339

  • Investigational Site Number 276022

    Magdeburg, 39120

  • Investigational Site Number 276008

    Neumünster, 24534

  • Investigational Site Number 276017

    Neuwied, 56564

  • Investigational Site Number 276004

    Oldenburg, 26133

  • Investigational Site Number 276003

    Pirna, 01796

  • Investigational Site Number 276006

    Riesa, 01587

  • Investigational Site Number 276010

    Saarlouis, 66740

  • Investigational Site Number 276016

    Sulzbach-Rosenberg, 92237

Other trials in Germany

Spain14 sites

  • Investigational Site Number 724007

    Badalona, 08915

  • Investigational Site Number 724001

    Barcelona, 08025

  • Investigational Site Number 724006

    Ferrol, 15405

  • Investigational Site Number 724013

    Granada, 18003

  • Investigational Site Number 724005

    Madrid, 28040

  • Investigational Site Number 724004

    Madrid

  • Investigational Site Number 724011

    Majadahonda, 28222

  • Investigational Site Number 724008

    Málaga, 29010

  • Investigational Site Number 724014

    Oviedo, 33006

  • Investigational Site Number 724009

    Palma de Mallorca, 07198

  • Investigational Site Number 724002

    Pamplona, 31008

  • Investigational Site Number 724010

    Sant Joan Despí, 08970

  • Investigational Site Number 724012

    Segovia

  • Investigational Site Number 724003

    Seville, 41071

Other trials in Spain

United Kingdom13 sites

  • Investigational Site Number 826010

    Airdrie, ML60JS

  • Investigational Site Number 826011

    Bath, BA13NG

  • Investigational Site Number 826009

    Bournemouth, BH77DW

  • Investigational Site Number 826005

    Bradford, BD96RJ

  • Investigational Site Number 826004

    Bristol, BS28HW

  • Investigational Site Number 826001

    Burton-on-Trent, DE13 0RB

  • Investigational Site Number 826015

    Durham, DH15TW

  • Investigational Site Number 826012

    High Wycombe, HP112TT

  • Investigational Site Number 826007

    Manchester, M239LT

  • Investigational Site Number 826006

    Peterborough, PE39QZ

  • Investigational Site Number 826003

    Southampton, SO303JB

  • Investigational Site Number 826008

    Truro, TR13LJ

  • Investigational Site Number 826002

    Welwyn Garden City, AL74HQ

Other trials in United Kingdom

Italy12 sites

  • Investigational Site Number 380004

    Catania, 95122

  • Investigational Site Number 380003

    Catanzaro

  • Investigational Site Number 380011

    Como, 22100

  • Investigational Site Number 380006

    Milan, 20132

  • Investigational Site Number 380007

    Milan, 20162

  • Investigational Site Number 380005

    Moncalieri, 10024

  • Investigational Site Number 380009

    Naples, 80138

  • Investigational Site Number 380008

    Padova

  • Investigational Site Number 380002

    Palermo, 90127

  • Investigational Site Number 380001

    Pisa, 56124

  • Investigational Site Number 380010

    Roma, 00133

  • Investigational Site Number 380012

    Verona, 37126

Other trials in Italy

France9 sites

  • Investigational Site Number 250-008

    Besançon, 25030

  • Investigational Site Number 250-005

    Corbeil-Essonnes, 91100

  • Investigational Site Number 250-004

    La Rochelle, 17019

  • Investigational Site Number 250-003

    Le Creusot, 71200

  • Investigational Site Number 250-009

    Mulhouse

  • Investigational Site Number 250-002

    Nantes, 44093

  • Investigational Site Number 250-007

    Paris, 75018

  • Investigational Site Number 250-006

    Strasbourg, 67098

  • Investigational Site Number 250-001

    Toulouse, 31059

Other trials in France

Austria5 sites

  • Investigational Site Number 040002

    Innsbruck, 6020

  • Investigational Site Number 040005

    Linz, 4021

  • Investigational Site Number 040003

    Salzburg, 5020

  • Investigational Site Number 040004

    Salzburg, 5026

  • Investigational Site Number 040001

    Vienna, 1160

Other trials in Austria

Netherlands5 sites

  • Investigational Site Number 528002

    Apeldoorn, 7334 DZ

  • Investigational Site Number 528005

    Groningen

  • Investigational Site Number 528003

    Hoogeveen, 7909AA

  • Investigational Site Number 528001

    Rotterdam, 3045PM

  • Investigational Site Number 528004

    Utrecht

Other trials in Netherlands

Belgium3 sites

  • Investigational Site Number 056002

    Edegem, 2650

  • Investigational Site Number 056003

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056001

    Leuven, 3000

Other trials in Belgium

Switzerland2 sites

  • Investigational Site Number 756001

    Olten, 4600

  • Investigational Site Number 756003

    Sankt Gallen, 9016

Other trials in Switzerland

About this study

Official title: 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.
Read more

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).

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.

Being tested
Alirocumab, Placebo, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
Medical subject headings
Hypercholesterolemia

What participants receive

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

  • AlirocumabDrug

    Also called Praluent, SAR236553, REGN727

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

  • PlaceboDrug

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

  • Lipid-Modifying Therapy (LMT)Drug

    Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.

  • Antihyperglycemic DrugDrug

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

Study groups in NCT02585778
Study groupRoleWhat they receive
Alirocumab 75 mg Q2W/Up to 150 mg Q2WExperimentalAlirocumab 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.
Receives: Drug: Alirocumab; Drug: Lipid-Modifying Therapy (LMT); Drug: Antihyperglycemic Drug
Placebo Q2WPlacebo comparatorPlacebo (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.
Receives: Drug: Placebo; Drug: Lipid-Modifying Therapy (LMT); 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 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).

    Measured: From Baseline to Week 24

  2. 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).

    Measured: From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks)

Secondary outcomes (26)

  1. 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).

    Measured: From Baseline to Week 24

  2. 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.

    Measured: From Baseline to Week 24

  3. 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.

    Measured: From Baseline to Week 24

  4. 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.

    Measured: From Baseline to Week 24

  5. 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.

    Measured: From Baseline to Week 24

  6. 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.

    Measured: From Baseline to Week 24

  7. 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.

    Measured: From Baseline to Week 24

  8. 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).

    Measured: Up to Week 24

  9. 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.

    Measured: Up to Week 24

  10. 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).

    Measured: Up to Week 24

  11. 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).

    Measured: Up to Week 24

  12. 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.

    Measured: From Baseline to Week 24

  13. 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.

    Measured: From Baseline to Week 24

  14. 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.

    Measured: From Baseline to Week 24

  15. 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.

    Measured: From Baseline to Week 24

  16. 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.

    Measured: From Baseline to Week 24

  17. 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.

    Measured: Baseline, Weeks 12 and 24

  18. 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.

    Measured: Baseline, Weeks 12 and 24

  19. 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.

    Measured: Baseline, Weeks 12 and 24

  20. 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.

    Measured: Baseline, Weeks 12 and 24

  21. 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.

    Measured: Baseline, Weeks 12 and 24

  22. 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.

    Measured: Baseline, Weeks 12 and 24

  23. 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.

    Measured: Baseline, Weeks 12 and 24

  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.

    Measured: Baseline, Weeks 12 and 24

  25. 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.

    Measured: Baseline, Weeks 12 and 24

  26. 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.

    Measured: Baseline, Weeks 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 posted23 Oct 2015 (estimated)
  2. Study start23 Oct 2015
  3. Primary completion3 Apr 2017
  4. Study completion3 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585778
Sponsor's protocol ID
LPS14355
Other IDs
2015-000799-92, U1111-1172-4772, 2015
Status last verified
Apr 2018
First submitted
22 Oct 2015
Last updated
17 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

  • 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

  • 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.

    PubMed 28905478

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alirocumab, Lipid-Modifying Therapy (LMT) and Antihyperglycemic Drug in people with Hypercholesterolaemia, run by Sanofi at 110 sites in 10 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 7 inclusion and 11 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 17 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 110 sites in United States, Germany, Spain, United Kingdom, Italy and 5 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 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 Calculated LDL-C at Week 24 - 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 NCT02585778, which also lists 3 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 17 May 2018.

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