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: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02642159
• Date of registration: 24/12/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• 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
• Date of first enrolment: March 15, 2016
• Target sample size: 413
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02642159
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not
adequately controlled with a stable, maximum dose/regimen of statin that was tolerated
by the participant.

- 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 prior to the screening visit
and between screening and randomization (including stable insulin dose defined as no
variation more than 30% in daily insulin dose within the preceding 3 months, as judged
by the Investigator).

- 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.

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.

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dyslipidemia

Intervention(s)

Drug: Fenofibrate

Drug: Antihyperglycemic Drug

Drug: Ezetimibe

Drug: Omega-3 fatty acids

Drug: Nicotinic acid

Drug: Statins

Drug: Alirocumab

Primary Outcome(s)

Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis [Time Frame: From Baseline to Week 24]

Secondary Outcome(s)

Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis [Time Frame: Baseline, Week 12 and 24]

Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis [Time Frame: Baseline, Week 12 and 24]

Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis [Time Frame: Baseline, Week 12 and 24]

Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis [Time Frame: From Baseline to Week 24]

Secondary ID(s)

LPS14354

U1111-1172-5262

2015-001934-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 01/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02642159