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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02642159




Registration number
NCT02642159
Ethics application status
Date submitted
24/12/2015
Date registered
30/12/2015
Date last updated
1/05/2018

Titles & IDs
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
Secondary ID [1] 0 0
2015-001934-19
Secondary ID [2] 0 0
LPS14354
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alirocumab
Treatment: Drugs - Statins
Treatment: Drugs - Ezetimibe
Treatment: Drugs - Fenofibrate
Treatment: Drugs - Nicotinic acid
Treatment: Drugs - Omega-3 fatty acids
Treatment: Drugs - Antihyperglycemic Drug

Experimental: Alirocumab 75 mg Q2W/Up to 150 mg Q2W - Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapy (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels \>=100 mg/dL (2.59 mmol/L) at Week 8.

Active comparator: Usual Care - Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.


Treatment: Drugs: Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

Treatment: Drugs: Statins
Statins at stable dose without other LMT as clinically indicated.

Treatment: Drugs: Ezetimibe
Pharmaceutical form: tablet Route of administration: oral

Treatment: Drugs: Fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Treatment: Drugs: Nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Treatment: Drugs: Omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Treatment: Drugs: Antihyperglycemic Drug
Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis
Timepoint [1] 0 0
From Baseline to Week 24
Primary outcome [2] 0 0
Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [2] 0 0
From Baseline to Week 24
Secondary outcome [1] 0 0
Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis
Timepoint [1] 0 0
From Baseline to Week 24
Secondary outcome [2] 0 0
Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [2] 0 0
From Baseline to Week 24
Secondary outcome [3] 0 0
Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis
Timepoint [3] 0 0
From Baseline to Week 24
Secondary outcome [4] 0 0
Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [4] 0 0
From Baseline to Week 24
Secondary outcome [5] 0 0
Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis
Timepoint [5] 0 0
From Baseline to Week 24
Secondary outcome [6] 0 0
Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [6] 0 0
From Baseline to Week 24
Secondary outcome [7] 0 0
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis
Timepoint [7] 0 0
From Baseline to Week 24
Secondary outcome [8] 0 0
Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [8] 0 0
From Baseline to Week 24
Secondary outcome [9] 0 0
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis
Timepoint [9] 0 0
From Baseline to Week 24
Secondary outcome [10] 0 0
Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [10] 0 0
From Baseline to Week 24
Secondary outcome [11] 0 0
Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis
Timepoint [11] 0 0
From Baseline to Week 24
Secondary outcome [12] 0 0
Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [12] 0 0
From Baseline to Week 24
Secondary outcome [13] 0 0
Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis
Timepoint [13] 0 0
From Baseline to Week 24
Secondary outcome [14] 0 0
Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [14] 0 0
From Baseline to Week 24
Secondary outcome [15] 0 0
Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis
Timepoint [15] 0 0
From Baseline to Week 24
Secondary outcome [16] 0 0
Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [16] 0 0
From Baseline to Week 24
Secondary outcome [17] 0 0
Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis
Timepoint [17] 0 0
From Baseline to Week 24
Secondary outcome [18] 0 0
Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Timepoint [18] 0 0
From Baseline to Week 24
Secondary outcome [19] 0 0
Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis
Timepoint [19] 0 0
Baseline, Week 12 and 24
Secondary outcome [20] 0 0
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis
Timepoint [20] 0 0
Baseline, Week 12 and 24
Secondary outcome [21] 0 0
Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis
Timepoint [21] 0 0
Baseline, Week 12 and 24

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2017
Sample size
Target
Accrual to date
Final
413
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036102 - Herston
Recruitment hospital [2] 0 0
Investigational Site Number 036104 - Merewether
Recruitment hospital [3] 0 0
Investigational Site Number 036101 - St Leonards
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Brazil
State/province [23] 0 0
Campinas
Country [24] 0 0
Brazil
State/province [24] 0 0
Fortaleza
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
São paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
SãO Paulo
Country [29] 0 0
Finland
State/province [29] 0 0
Oulu
Country [30] 0 0
Finland
State/province [30] 0 0
Tampere
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Dippoldiswalde
Country [33] 0 0
Germany
State/province [33] 0 0
Dresden
Country [34] 0 0
Germany
State/province [34] 0 0
Essen
Country [35] 0 0
Germany
State/province [35] 0 0
Goch
Country [36] 0 0
Germany
State/province [36] 0 0
Karlsruhe
Country [37] 0 0
Germany
State/province [37] 0 0
Künzing
Country [38] 0 0
Germany
State/province [38] 0 0
Oldenburg in Holstein
Country [39] 0 0
Israel
State/province [39] 0 0
Beer Sheva
Country [40] 0 0
Israel
State/province [40] 0 0
Petach Tikva
Country [41] 0 0
Israel
State/province [41] 0 0
Petach tikva
Country [42] 0 0
Israel
State/province [42] 0 0
Rehovot
Country [43] 0 0
Israel
State/province [43] 0 0
Tel-Aviv
Country [44] 0 0
Italy
State/province [44] 0 0
Bergamo
Country [45] 0 0
Italy
State/province [45] 0 0
Catanzaro
Country [46] 0 0
Italy
State/province [46] 0 0
Napoli
Country [47] 0 0
Italy
State/province [47] 0 0
Padova
Country [48] 0 0
Italy
State/province [48] 0 0
Partinico
Country [49] 0 0
Italy
State/province [49] 0 0
Pisa
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Torino
Country [52] 0 0
Kuwait
State/province [52] 0 0
Kuwait
Country [53] 0 0
Lebanon
State/province [53] 0 0
Beirut
Country [54] 0 0
Lebanon
State/province [54] 0 0
Hazmieh
Country [55] 0 0
Norway
State/province [55] 0 0
Oslo
Country [56] 0 0
Sweden
State/province [56] 0 0
Göteborg
Country [57] 0 0
Sweden
State/province [57] 0 0
Stockholm
Country [58] 0 0
Switzerland
State/province [58] 0 0
Genève
Country [59] 0 0
Switzerland
State/province [59] 0 0
Olten
Country [60] 0 0
Switzerland
State/province [60] 0 0
Reinach
Country [61] 0 0
Turkey
State/province [61] 0 0
Adana
Country [62] 0 0
Turkey
State/province [62] 0 0
Ankara
Country [63] 0 0
Turkey
State/province [63] 0 0
Corum
Country [64] 0 0
Turkey
State/province [64] 0 0
Hatay
Country [65] 0 0
Turkey
State/province [65] 0 0
Izmir
Country [66] 0 0
Turkey
State/province [66] 0 0
Kayseri
Country [67] 0 0
Turkey
State/province [67] 0 0
Samsun
Country [68] 0 0
United Arab Emirates
State/province [68] 0 0
Dubai
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Exeter
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Manchester
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Middlesborough
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Stevenage
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Torquay
Country [74] 0 0
United Kingdom
State/province [74] 0 0
West Bromwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02642159