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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT02585778

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.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:40 AM EDT

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

Study identification

NCT ID
NCT02585778
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
517 participants

Conditions and interventions

Interventions

  • Alirocumab Drug
  • Antihyperglycemic Drug Drug
  • Lipid-Modifying Therapy (LMT) Drug
  • Placebo 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 22, 2015
Primary completion
Apr 2, 2017
Completion
Apr 2, 2017
Last update posted
May 16, 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 16, 2018 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02585778 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →