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)

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2015-001934-19-DE
• Date of registration: 27/01/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Aventis Groupe
• Public title: 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)
• Scientific 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 - ODYSSEY DM - DYSLIPIDEMIA
• Date of first enrolment: 07/04/2016
• Target sample size: 420
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001934-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no 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): no Therapeutic use (Phase IV): yes

Countries of recruitment

Australia, Austria, Brazil, Finland, Germany, Israel, Italy, Kuwait, Lebanon, Norway, Sweden, Turkey, United Arab Emirates, United Kingdom

Contacts

• Affiliation: Sanofi-Aventis Deutschland GmbH

• Affiliation: Sanofi-Aventis Deutschland GmbH

Key inclusion & exclusion 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.

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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Dyslipidemia
MedDRA version: 20.0 Level: PT Classification code 10058108 Term: Dyslipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

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

Intervention(s)

Trade Name: Praluent
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: alirocumab
CAS Number: 1245916-14-6
Current Sponsor code: SAR236653 (REGN727)
Other descriptive name: ALIROCUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-

Trade Name: Praluent
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: alirocumab
CAS Number: 1245916-14-6
Current Sponsor code: SAR236653 (REGN727)
Other descriptive name: ALIROCUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Product Name: Ezetimibe
Pharmaceutical Form:
INN or Proposed INN: Ezetimibe
Other descriptive name: EZETIMIBE

Product Name: Nicotinic acid
Pharmaceutical Form:
INN or Proposed INN: Nicotinic acid
Other descriptive name: NICOTINIC ACID

Product Name: Omega 3 fatty acids
Pharmaceutical Form:
INN or Proposed INN: Omega-3 fatty acids
Other descriptive name: OMEGA-3 FATTY ACIDS

Product Name: fenofibrate
Pharmaceutical Form:
INN or Proposed INN: Fenofibrate
CAS Number: 49562-28-9
Other descriptive name: FENOFIBRATE

Primary Outcome(s)

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

Main 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.

Primary end point(s): Percent change in non-HDL-C in the intent-to-treat (ITT) population

Secondary Objective: -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).

Secondary Outcome(s)

Secondary end point(s): a)Percent change in measured LDL-C
b)Percent change in non-HDL-C
c)Percent change in measured LDL-C
d)Percent change in Apo B
e)Percent change in Total-C
f)Percent change in Lp(a)
g)Percent change in TG
h)Percent change in HDL-C
i)Percent change in LDL-C particle number
l)Number of patients with adverse events

Timepoint(s) of evaluation of this end point: a)From baseline to Week 24
b)From baseline to Week 12
c)From baseline to Week 12
d)From baseline to Week 24
e)From baseline to Week 24
f)From baseline to Week 24
g)From baseline to Week 24
h)From baseline to Week 24
i)From baseline to Week 24
l)From baseline to Week 32

Secondary ID(s)

2015-001934-19-FI

LPS14354

Source(s) of Monetary Support

Sanofi-aventis groupe