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Trial record 1 of 1 for:    ODYSSEY DM-Dyslipidemia
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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)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02642159
First received: December 24, 2015
Last updated: June 21, 2017
Last verified: June 2017
  Purpose

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 patients 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 diabetes parameters with alirocumab vs. usual care treatment.
  • To demonstrate the safety and tolerability of alirocumab.
  • To evaluate treatment acceptance of alirocumab.
  • To evaluate PCSK9 concentrations and antibody development.
  • To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).

Condition Intervention Phase
Dyslipidemia Drug: ALIROCUMAB SAR236553 (REGN727) Drug: placebo Drug: statins Drug: ezetimibe Drug: fenofibrate Drug: nicotinic acid Drug: omega-3 fatty acids Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent change in non-HDL-C in the intent-to-treat (ITT) population [ Time Frame: From baseline to Week 24 ]

Secondary Outcome Measures:
  • Percent change in measured LDL-C [ Time Frame: From baseline to Week 24 ]
  • Percent change in non-HDL-C [ Time Frame: From baseline to Week 12 ]
  • Percent change in measured LDL-C [ Time Frame: From baseline to Week 12 ]
  • Percent change in Apo B [ Time Frame: From baseline to Week 24 ]
  • Percent change in Total-C [ Time Frame: From baseline to Week 24 ]
  • Percent change in Lp(a) [ Time Frame: From baseline to Week 24 ]
  • Percent change in TG [ Time Frame: From baseline to Week 24 ]
  • Percent change in HDL-C [ Time Frame: From baseline to Week 24 ]
  • Percent change in LDL-C particle number [ Time Frame: From baseline to Week 24 ]
  • Number of patients with adverse events [ Time Frame: From baseline to Week 32 ]

Enrollment: 413
Study Start Date: March 15, 2016
Study Completion Date: May 18, 2017
Primary Completion Date: March 17, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab
Will be injected subcutaneously every 2 weeks starting with Dose 1 with potential blinded uptitration to Dose 2 at Week 12. Background therapy such as antihyperglycemic agents and statins will be administered as applicable or as per Investigator's judgment. A placebo injection for training purposes will be administered to the patients.
Drug: ALIROCUMAB SAR236553 (REGN727)
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Praluent
Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Drug: statins
Pharmaceutical form:tablet Route of administration: oral
Active Comparator: Usual Care
Will be administered orally based on the selection of the Investigator prior to randomization and includes initiation of either ezetimibe, fenofibrate, nicotinic acid or omega-3 fatty acids. Alternatively, if randomized to the usual care arm, the Investigator may select the addition of no additional lipid lowering agent. Background therapy such as antihyperglycemic agents and statins will be administered as applicable or as per Investigator's judgment. A placebo injection for training purposes will be administered to the patients.
Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Drug: statins
Pharmaceutical form:tablet Route of administration: oral
Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral
Drug: fenofibrate
Pharmaceutical form:tablet Route of administration: oral
Drug: nicotinic acid
Pharmaceutical form:tablet Route of administration: oral
Drug: omega-3 fatty acids
Pharmaceutical form:tablet Route of administration: oral

Detailed Description:

The maximum study duration will be approximately 9 months per patient, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period.

If needed for the purpose of scientific communication, a first-step analysis (both efficacy and safety) will be performed at the Week 24 cut-off date. A second-step analysis will be performed once all patients have completed the study and will include a final update of the safety analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with type 2 diabetes and mixed dyslipidemia whose non-high-density lipoprotein cholesterol (non-HDL-C) is not adequately controlled with a stable, maximum dose/regimen of statin that is tolerated by the patient.
  • 18 years of age or more.
  • Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
  • Non-HDL-C of 100 mg/dL or greater.
  • Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
  • Stable anti-hyperglycemic agents for at least 3 months.
  • No change in weight of more than 5 kg within the prior 3 months.
  • On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.

Exclusion criteria:

  • Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.
  • Currently drinking more than 2 standard alcoholic drinks per day.
  • Body Mass Index (BMI) >45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.
  • Glycosylated hemoglobin (HbA1c) 9% or greater.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02642159

  Show 121 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02642159     History of Changes
Other Study ID Numbers: LPS14354
2015-001934-19 ( EudraCT Number )
U1111-1172-5262 ( Other Identifier: UTN )
Study First Received: December 24, 2015
Last Updated: June 21, 2017

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Ezetimibe
Niacin
Nicotinic Acids
Niacinamide
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antibodies, Monoclonal
Hypoglycemic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anticholesteremic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Enzyme Inhibitors
Immunologic Factors

ClinicalTrials.gov processed this record on June 23, 2017