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COMPLETED Phase 4

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)

NCT02642159 · View on ClinicalTrials.gov ↗

Study 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 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).

Conditions Studied

Interventions

  • DRUG Fenofibrate
  • DRUG Ezetimibe
  • DRUG Alirocumab
  • DRUG Statins
  • DRUG Nicotinic acid

Study Locations (20)

California

  • Investigational Site Number 840-141 — Fresno
  • Investigational Site Number 840-152 — Huntington Beach
  • Investigational Site Number 840-115 — La Jolla
  • Investigational Site Number 840-118 — Los Angeles
  • Investigational Site Number 840-106 — Northridge
  • Investigational Site Number 840-176 — Port Hueneme
  • Investigational Site Number 840-122 — Tarzana
  • Investigational Site Number 840-156 — Tustin
  • Investigational Site Number 840-160 — Van Nuys

Florida

  • Investigational Site Number 840-107 — Boca Raton
  • Investigational Site Number 840-170 — Boynton Beach
  • Investigational Site Number 840-114 — Bradenton
  • Investigational Site Number 840-132 — Ocoee
  • Investigational Site Number 840-179 — Oviedo
  • Investigational Site Number 840-123 — Tampa

Georgia

  • Investigational Site Number 840-137 — Bainbridge
  • Investigational Site Number 840-128 — Columbus
  • Investigational Site Number 840-169 — Stockbridge

Arkansas

  • Investigational Site Number 840-163 — Little Rock

Idaho

  • Investigational Site Number 840-167 — Idaho Falls

Trial Details

FieldValue
Enrollment Target 413 participants
Start Date 2016-03-15
Est. Completion 2017-05-15
Phase Phase 4

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02642159

The ClinicalTrials.gov registry entry for NCT02642159 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Dyslipidemia appearing as the primary indexed condition, and to 5 interventions — of which Fenofibrate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02642159 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02642159 about?

NCT02642159 is a clinical study titled "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)". 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 wit...

What is the current status of trial NCT02642159?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 413 participants. The study started on 2016-03-15. Estimated completion is 2017-05-15.

What conditions does trial NCT02642159 study?

This clinical trial studies the following conditions: Dyslipidemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02642159?

The interventions under investigation include: Fenofibrate (DRUG), Ezetimibe (DRUG), Alirocumab (DRUG), Statins (DRUG), Nicotinic acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02642159?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02642159 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial