Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 April 2019 |
Main ID: |
EUCTR2015-000799-92-GB |
Date of registration:
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01/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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. - ODYSSEY DM-Insulin |
Date of first enrolment:
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31/12/2015 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000799-92 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Finland
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France
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Germany
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Greece
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Medical Information
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Address:
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One Onslow Street
GU1 4YS
Guildford
United Kingdom |
Telephone:
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441483505515 |
Email:
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UK-MEDICALINFORMATION@Sanofi.com |
Affiliation:
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sanofi-aventis Groupe |
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Name:
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Medical Information
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Address:
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One Onslow Street
GU1 4YS
Guildford
United Kingdom |
Telephone:
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441483505515 |
Email:
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UK-MEDICALINFORMATION@Sanofi.com |
Affiliation:
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sanofi-aventis Groupe |
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Key inclusion & exclusion criteria
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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.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
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 m^2 according to modification in diet of 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/m^2 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).
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Hypercholesterolemia
MedDRA version: 18.1
Level: LLT
Classification code 10020604
Term: Hypercholesterolemia
System Organ Class: 100000004861
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Intervention(s)
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Trade Name: Praluent Product Name: Alirocumab Product Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: alirocumab CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN727) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Trade Name: Praluent Product Name: Alirocumab Product Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: alirocumab CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN727) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: 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.
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Primary end point(s): 1- Percent change in calculated LDL-C in the intent to treat (ITT) population 2- Number of patients with adverse events
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Timepoint(s) of evaluation of this end point: 1- From baseline to Week 24 2- From baseline to Week 32
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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).
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Secondary Outcome(s)
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Secondary end point(s): 1- Percent change in calculated LDL-C in the modified ITT (mITT) population
2- Percent change in measured LDL-C in the ITT population
3- Percent change in calculated LDL-C in the ITT population
4- Percent change in non-HDL-C in the ITT population
5- Percent change in Apo B in the ITT population
6- Percent change in total cholesterol in the ITT population
7- Proportion of patients reaching calculated LDL-C < 70 mg/dL in the mITT population
Proportion of patients reaching calculated LDL-C < 50 mg/dL in the mITT population
8- Proportion of patients reaching non-HDL < 100 mg/dL in the mITT population
Proportion of patients reaching non-HDL < 80 mg/dL in the mITT population
9- Percent change in Lp(a) in the ITT population
Percent change in HDL-C in the ITT population
10- Percent change in TG in the ITT population
Percent change in LDL-C particle number in the ITT population
Percent change in LDL-C particle size in the ITT population
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Timepoint(s) of evaluation of this end point: 1- From baseline to Week 24
2- From baseline to Weeks 12 and 24
3- From baseline to Week 12
4-5-6- From baseline to Week 24
7-8- Week 24
9-10- From baseline to Week 24
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Source(s) of Monetary Support
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sanofi-aventis Groupe
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Ethics review
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Status: Approved
Approval date:
Contact:
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