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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)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02585778
First received: October 22, 2015
Last updated: April 27, 2017
Last verified: April 2017
  Purpose

Primary Objectives:

  • To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients 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 patients with diabetes treated with insulin.

Secondary Objective:

To demonstrate that alirocumab is superior in comparison to placebo in its effects on other lipid parameters (ie, 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 CIII (Apo C-III), and LDL particle number and size).


Condition Intervention Phase
Hypercholesterolaemia Drug: ALIROCUMAB SAR236553 (REGN727) Drug: placebo Drug: insulin Drug: statin Drug: lipid modifying therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent change in calculated LDL-C in the intent to treat (ITT) population [ Time Frame: From baseline to Week 24 ]
  • Number of patients with adverse events [ Time Frame: From baseline to Week 32 ]

Secondary Outcome Measures:
  • Percent change in calculated LDL-C in the modified ITT (mITT) population [ Time Frame: From baseline to Week 24 ]
  • Percent change in measured LDL-C in the ITT population [ Time Frame: From baseline to Weeks 12 and 24 ]
  • Percent change in calculated LDL-C in the ITT population [ Time Frame: From baseline to Week 12 ]
  • Percent change in non-HDL-C in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Percent change in Apo B in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Percent change in total cholesterol in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Proportion of patients reaching calculated LDL-C < 70 mg/dL in the mITT population [ Time Frame: Week 24 ]
  • Proportion of patients reaching calculated LDL-C < 50 mg/dL in the mITT population [ Time Frame: Week 24 ]
  • Proportion of patients reaching non-HDL < 100 mg/dL in the mITT population [ Time Frame: Week 24 ]
  • Proportion of patients reaching non-HDL < 80 mg/dL in the mITT population [ Time Frame: Week 24 ]
  • Percent change in Lp(a) in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Percent change in HDL-C in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Percent change in TG in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Percent change in LDL-C particle number in the ITT population [ Time Frame: From baseline to Week 24 ]
  • Percent change in LDL-C particle size in the ITT population [ Time Frame: From baseline to Week 24 ]

Enrollment: 517
Study Start Date: October 23, 2015
Study Completion Date: April 3, 2017
Primary Completion Date: April 3, 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. The following background therapies: antihyperglycemic agents, statins, and other lipid modifying therapy will be administered as applicable or as per Investigator's discretion
Drug: ALIROCUMAB SAR236553 (REGN727)
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Praluent
Drug: insulin
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Lantus (insulin glargine)
Drug: insulin
Pharmaceutical form:powder Route of administration: inhalation
Other Name: Afrezza (insulin human)
Drug: statin
Pharmaceutical form:tablet Route of administration: oral
Drug: lipid modifying therapy
Pharmaceutical form:tablet Route of administration: oral
Placebo Comparator: Placebo
Will be injected subcutaneously every 2 weeks. The following background therapies: antihyperglycemic agents, statins, and other lipid modifying therapy will be administered as applicable or as per Investigator's discretion
Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Drug: insulin
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Lantus (insulin glargine)
Drug: insulin
Pharmaceutical form:powder Route of administration: inhalation
Other Name: Afrezza (insulin human)
Drug: statin
Pharmaceutical form:tablet Route of administration: oral
Drug: lipid modifying therapy
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.
  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 1 or type 2 diabetes treated with insulin whose LDL-C levels are not adequately controlled with maximally tolerated lipid-modifying therapy.
  • LDL-C of 70 mg/dL or greater.
  • 18 years of age or more.
  • Glycosylated hemoglobin (HbA1c) less than 10%.
  • History of cardiovascular disease (including CHD and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor.

Exclusion criteria:

  • Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening.
  • Triglycerides >400 mg/dL.
  • Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation.
  • Currently receiving or plans to receive renal replacement therapy (for example, hemodialysis).
  • Change in weight of more than 5 kilograms within the prior 2 months.
  • Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or plans to intensify insulin regimen during the study.
  • Not treated with insulin for at least 6 months.
  • Plans to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study.
  • Body mass index (BMI) >45 kg/m² or plans to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study
  • History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis).

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: NCT02585778

  Show 110 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02585778     History of Changes
Other Study ID Numbers: LPS14355
2015-000799-92 ( EudraCT Number )
U1111-1172-4772 ( Other Identifier: UTN )
Study First Received: October 22, 2015
Last Updated: April 27, 2017

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antibodies, Monoclonal
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 23, 2017