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)

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2015-000799-92-NL
• Date of registration: 27/10/2015
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Groupe
• Public title: 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)
• Scientific 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. - ODYSSEY DM-Insulin
• Date of first enrolment: 04/12/2015
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000799-92
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Brazil, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: CSU
• Affiliation: Sanofi Aventis Netherlands BV

• Name: CSU
• Affiliation: Sanofi Aventis Netherlands BV

Key inclusion & exclusion 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.

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

Health Condition(s) or Problem(s) studied

Hypercholesterolemia
MedDRA version: 18.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

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: range
Concentration number: 75-150
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: range
Concentration number: 75-150
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: 1- From baseline to Week 24

2- From baseline to Week 32

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

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).

Secondary Outcome(s)

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

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

Secondary ID(s)

2015-000799-92-GB

LPS14355

Source(s) of Monetary Support

sanofi-aventis Groupe