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)
Public ClinicalTrials.gov record NCT02585778. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objectives: * To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. * To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol \[non-HDL-C\], apolipoprotein B \[Apo B\], total cholesterol \[TC\], lipoprotein a \[Lp(a)\], high density lipoprotein cholesterol \[HDL-C\], triglyceride \[TG\] levels, triglyceride rich lipoproteins \[TGRL\], apolipoprotein A-1 \[Apo A-1\], apolipoprotein C-III \[Apo C-III\], and LDL particle number and size).
Study identification
- NCT ID
- NCT02585778
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 517 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab Drug
- Placebo Drug
- Lipid-Modifying Therapy (LMT) Drug
- Antihyperglycemic Drug Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 23, 2015 (Actual)
- Primary completion
- Apr 3, 2017 (Actual)
- Completion
- Apr 3, 2017 (Actual)
- Last update posted
- May 17, 2018
2015 – 2017
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840020 | Encino | California | 91436 | — |
| Investigational Site Number 840002 | Fresno | California | 93720 | — |
| Investigational Site Number 840029 | Oakland | California | 94612 | — |
| Investigational Site Number 840027 | Loveland | Colorado | 80538 | — |
| Investigational Site Number 840026 | Atlantis | Florida | 33462 | — |
| Investigational Site Number 840006 | Bradenton | Florida | 33180 | — |
| Investigational Site Number 840023 | Jacksonville | Florida | 32205 | — |
| Investigational Site Number 840028 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840022 | Ponte Vedra Beach | Florida | — | — |
| Investigational Site Number 840021 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840007 | Springfield | Illinois | 62704 | — |
| Investigational Site Number 840011 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840015 | Valparaiso | Indiana | 46383 | — |
| Investigational Site Number 840010 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840005 | Louisville | Kentucky | — | — |
| Investigational Site Number 840018 | Auburn | Maine | 04210 | — |
| Investigational Site Number 840013 | Hyattsville | Maryland | 20782 | — |
| Investigational Site Number 840016 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840004 | Minneapolis | Minnesota | 55416 | — |
| Investigational Site Number 840012 | Jamaica | New York | 11432 | — |
| Investigational Site Number 840014 | Maumee | Ohio | 43537 | — |
| Investigational Site Number 840009 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840024 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840001 | Austin | Texas | 78756 | — |
| Investigational Site Number 840003 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840019 | Dallas | Texas | 75246 | — |
| Investigational Site Number 840025 | Houston | Texas | 77090 | — |
| Investigational Site Number 840017 | Ogden | Utah | 84405 | — |
| Investigational Site Number 840008 | Salt Lake City | Utah | 84102 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02585778, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2018 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02585778 live on ClinicalTrials.gov.