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)
Public ClinicalTrials.gov record NCT02642159. 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, 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02642159
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 413 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab Drug
- Statins Drug
- Ezetimibe Drug
- Fenofibrate Drug
- Nicotinic acid Drug
- Omega-3 fatty acids 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
- Mar 15, 2016 (Type not available)
- Primary completion
- Mar 22, 2017 (Actual)
- Completion
- May 15, 2017 (Actual)
- Last update posted
- May 1, 2018
2016 – 2017
United States locations
- U.S. sites
- 57
- U.S. states
- 22
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840-163 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840-141 | Fresno | California | 93720 | — |
| Investigational Site Number 840-152 | Huntington Beach | California | 92648 | — |
| Investigational Site Number 840-115 | La Jolla | California | 92037 | — |
| Investigational Site Number 840-118 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840-106 | Northridge | California | 91325 | — |
| Investigational Site Number 840-176 | Port Hueneme | California | 93041 | — |
| Investigational Site Number 840-122 | Tarzana | California | 91356 | — |
| Investigational Site Number 840-156 | Tustin | California | 92780-6953 | — |
| Investigational Site Number 840-160 | Van Nuys | California | 91405 | — |
| 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 840-132 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 840-179 | Oviedo | Florida | 32765 | — |
| Investigational Site Number 840-123 | Tampa | Florida | 33634 | — |
| Investigational Site Number 840-137 | Bainbridge | Georgia | 39819 | — |
| Investigational Site Number 840-128 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 840-169 | Stockbridge | Georgia | 30281 | — |
| Investigational Site Number 840-167 | Idaho Falls | Idaho | 83404 | — |
| Investigational Site Number 840-161 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 840-184 | Crystal Lake | Illinois | 60012 | — |
| Investigational Site Number 840-174 | Evanston | Illinois | 60201 | — |
| Investigational Site Number 840-138 | Springfield | Illinois | 62711 | — |
| Investigational Site Number 840-108 | Louisville | Kentucky | — | — |
| Investigational Site Number 840-183 | Paducah | Kentucky | 42003 | — |
| Investigational Site Number 840-190 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 840-151 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840-113 | Jefferson City | Missouri | 65109 | — |
| Investigational Site Number 840-120 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840-148 | Omaha | Nebraska | 68131-2137 | — |
| Investigational Site Number 840-101 | Las Vegas | Nevada | 89119 | — |
| Investigational Site Number 840-140 | Las Vegas | Nevada | 89128 | — |
| Investigational Site Number 840-178 | Albany | New York | 12206 | — |
| Investigational Site Number 840-181 | New York | New York | 10016 | — |
| Investigational Site Number 840-157 | New York | New York | 10029 | — |
| Investigational Site Number 840-188 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 840-131 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 840-158 | Morganton | North Carolina | 28655 | — |
| Investigational Site Number 840-129 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840-104 | Columbus | Ohio | 43213 | — |
| Investigational Site Number 840-105 | Marion | Ohio | 43302 | — |
| Investigational Site Number 840-175 | Maumee | Ohio | 43537 | — |
| Investigational Site Number 840-136 | Bend | Oregon | 97702 | — |
| Investigational Site Number 840-187 | Murrells Inlet | South Carolina | 29576-9351 | — |
| Investigational Site Number 840-111 | Summerville | South Carolina | 29485 | — |
| Investigational Site Number 840-147 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840-159 | Knoxville | Tennessee | 37920 | — |
| Investigational Site Number 840-153 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840-143 | Houston | Texas | 77095 | — |
| Investigational Site Number 840-168 | Houston | Texas | 77099 | — |
| Investigational Site Number 840-142 | Round Rock | Texas | 78681 | — |
| Investigational Site Number 840-133 | Tomball | Texas | 77375 | — |
| Investigational Site Number 840-185 | Orem | Utah | 84058 | — |
| Investigational Site Number 840-150 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 840-126 | Chesapeake | Virginia | 23321 | — |
| Investigational Site Number 840-171 | Richmond | Virginia | 23249 | — |
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 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02642159, 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 1, 2018 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02642159 live on ClinicalTrials.gov.