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NCT02585778 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Hypercholesterolaemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
- 20
- Study locations
NCT02585778: Completed Phase 3 study of Hypercholesterolaemia, sponsored by Sanofi.
NCT02585778 is a Phase 3 study of Hypercholesterolaemia that has completed, run by Sanofi. The registered enrollment target is 517 participants, below the 4,884-participant average among 3 other Hypercholesterolaemia trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02585778, a Phase 3 study of Hypercholesterolaemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Alirocumab
- DRUG Lipid-Modifying Therapy (LMT)
- DRUG Antihyperglycemic Drug
Study Locations (20)
Florida
- Investigational Site Number 840026 - Atlantis
- Investigational Site Number 840006 - Bradenton
- Investigational Site Number 840023 - Jacksonville
- Investigational Site Number 840028 - Palm Harbor
- Investigational Site Number 840022 - Ponte Vedra Beach
California
- Investigational Site Number 840020 - Encino
- Investigational Site Number 840002 - Fresno
- Investigational Site Number 840029 - Oakland
Indiana
- Investigational Site Number 840011 - Indianapolis
- Investigational Site Number 840015 - Valparaiso
Maryland
- Investigational Site Number 840013 - Hyattsville
- Investigational Site Number 840016 - Rockville
Colorado
- Investigational Site Number 840027 - Loveland
Georgia
- Investigational Site Number 840021 - Roswell
Illinois
- Investigational Site Number 840007 - Springfield
Iowa
- Investigational Site Number 840010 - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2015-10-23 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 3 |
What the finished NCT02585778 record still lists
NCT02585778 is an interventional study that assigns participants to a tested intervention. The registered 517 participants enrollment target is mid-sized for trials with a published cap, below the 4,884-participant average among 3 other Hypercholesterolaemia trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Hypercholesterolaemia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02585778 names 20 study sites across 12 states, led by Florida, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT02585778 about?
NCT02585778 is a clinical study titled "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)". 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 contro...
What is the current status of trial NCT02585778?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2015-10-23. Estimated completion is 2017-04-03.
What conditions does trial NCT02585778 study?
This clinical trial studies the following conditions: Hypercholesterolaemia.
What interventions are being tested in trial NCT02585778?
The interventions under investigation include: Placebo (DRUG), Alirocumab (DRUG), Lipid-Modifying Therapy (LMT) (DRUG), Antihyperglycemic Drug (DRUG).
Who is sponsoring clinical trial NCT02585778?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02585778 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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