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 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000799-92-GB

Enrollment

500

Registered

2015-10-01

Start date

2015-12-31

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Praluent Product Name: Alirocumab Product Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion 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

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) 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).

Design outcomes

Primary

Measure	Time frame
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. ;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).; 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 ; Timepoint(s) of evaluation of this end point: 1- From baseline to Week 24 2- From baseline to Week 32	—

Measure

Time frame

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. ;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).; 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 ; 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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

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

Contacts

Public ContactMedical Information

sanofi-aventis Groupe

UK-MEDICALINFORMATION@Sanofi.com441483505515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026