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NCT02642159 · ClinicalTrials.gov registry record · 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)

A Phase 4 study of Dyslipidemia, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
413
Enrollment target
20
Study locations

NCT02642159 is a Phase 4 study of Dyslipidemia that has completed, run by Sanofi. The registered enrollment target is 413 participants, above the 353-participant average among 40 other Dyslipidemia trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT02642159, a Phase 4 study of Dyslipidemia, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
413 participants
Enrollment target
20
Study locations

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

Dyslipidemia

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

713 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, categorized as Phase 4. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 353-participant average among 40 other Dyslipidemia trials with a reported enrollment target (17% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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.

NCT02642159 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

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.

What interventions are being tested in trial NCT02642159?

The interventions under investigation include: Fenofibrate (DRUG), Ezetimibe (DRUG), Alirocumab (DRUG), Statins (DRUG), Nicotinic acid (DRUG).

Who is sponsoring clinical trial NCT02642159?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.