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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)
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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
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Secondary ID [1]
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0
2015-001934-19
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Secondary ID [2]
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0
LPS14354
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Other cardiovascular diseases
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Blood
0
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0
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis
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Assessment method [1]
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Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
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Timepoint [1]
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From Baseline to Week 24
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Primary outcome [2]
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Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [2]
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [2]
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From Baseline to Week 24
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Secondary outcome [1]
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Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis
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Assessment method [1]
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Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [1]
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0
From Baseline to Week 24
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Secondary outcome [2]
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Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [2]
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Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [2]
0
0
From Baseline to Week 24
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Secondary outcome [3]
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Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis
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Assessment method [3]
0
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [3]
0
0
From Baseline to Week 24
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Secondary outcome [4]
0
0
Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [4]
0
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [4]
0
0
From Baseline to Week 24
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Secondary outcome [5]
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Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis
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Assessment method [5]
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Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [5]
0
0
From Baseline to Week 24
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Secondary outcome [6]
0
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Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [6]
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Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [6]
0
0
From Baseline to Week 24
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Secondary outcome [7]
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Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis
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Assessment method [7]
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [7]
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0
From Baseline to Week 24
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Secondary outcome [8]
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Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [8]
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [8]
0
0
From Baseline to Week 24
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Secondary outcome [9]
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Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis
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Assessment method [9]
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [9]
0
0
From Baseline to Week 24
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Secondary outcome [10]
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Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [10]
0
0
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [10]
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0
From Baseline to Week 24
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Secondary outcome [11]
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Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis
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Assessment method [11]
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Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
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Timepoint [11]
0
0
From Baseline to Week 24
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Secondary outcome [12]
0
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Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [12]
0
0
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [12]
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From Baseline to Week 24
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Secondary outcome [13]
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Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis
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Assessment method [13]
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Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [13]
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From Baseline to Week 24
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Secondary outcome [14]
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Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [14]
0
0
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [14]
0
0
From Baseline to Week 24
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Secondary outcome [15]
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Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis
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Assessment method [15]
0
0
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [15]
0
0
From Baseline to Week 24
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Secondary outcome [16]
0
0
Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [16]
0
0
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [16]
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0
From Baseline to Week 24
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Secondary outcome [17]
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Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis
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Assessment method [17]
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LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.
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Timepoint [17]
0
0
From Baseline to Week 24
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Secondary outcome [18]
0
0
Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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Assessment method [18]
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LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.
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Timepoint [18]
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0
From Baseline to Week 24
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Secondary outcome [19]
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Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis
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Assessment method [19]
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Absolute change = HbA1c value at specified week minus HbA1c value at baseline.
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Timepoint [19]
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Baseline, Week 12 and 24
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Secondary outcome [20]
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Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis
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Assessment method [20]
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Absolute change = FPG value at specified week minus FPG value at baseline.
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Timepoint [20]
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Baseline, Week 12 and 24
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Secondary outcome [21]
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Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis
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Assessment method [21]
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Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.
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Timepoint [21]
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Baseline, Week 12 and 24
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/05/2017
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Sample size
Target
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Accrual to date
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Final
413
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036102 - Herston
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Recruitment hospital [2]
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Investigational Site Number 036104 - Merewether
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Recruitment hospital [3]
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Investigational Site Number 036101 - St Leonards
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Recruitment postcode(s) [1]
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4006 - Herston
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Recruitment postcode(s) [2]
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2291 - Merewether
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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0
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United States of America
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California
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United States of America
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Florida
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Georgia
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Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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South Carolina
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Tennessee
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Virginia
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Brazil
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Campinas
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Brazil
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Fortaleza
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Brazil
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Sao Paulo
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Brazil
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São paulo
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Brazil
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São Paulo
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Brazil
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SãO Paulo
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Finland
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Oulu
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Finland
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Tampere
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Germany
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Berlin
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Germany
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Dippoldiswalde
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Germany
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Dresden
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Germany
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Essen
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Germany
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Goch
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Germany
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Karlsruhe
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Germany
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Künzing
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Germany
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Oldenburg in Holstein
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Israel
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Beer Sheva
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Israel
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Petach Tikva
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Israel
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Petach tikva
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Israel
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Rehovot
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Israel
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Tel-Aviv
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Italy
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Bergamo
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Italy
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Catanzaro
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Italy
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Napoli
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Italy
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Padova
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Italy
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Partinico
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Italy
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Pisa
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Italy
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Roma
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Italy
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Torino
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Kuwait
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Kuwait
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Lebanon
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Beirut
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Lebanon
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Hazmieh
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Norway
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Oslo
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Sweden
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Göteborg
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Sweden
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Stockholm
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Switzerland
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Genève
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Switzerland
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Olten
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Switzerland
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Reinach
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0
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Turkey
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Adana
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Turkey
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Ankara
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0
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Turkey
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0
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Corum
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Turkey
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Hatay
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Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Samsun
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United Arab Emirates
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Dubai
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United Kingdom
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Exeter
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United Kingdom
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Manchester
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United Kingdom
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Middlesborough
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United Kingdom
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Stevenage
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United Kingdom
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Torquay
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United Kingdom
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West Bromwich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Other collaborator category [1]
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Commercial sector/industry
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Regeneron Pharmaceuticals
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Ethics approval
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Summary
Brief summary
Primary 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 participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: * 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 glycemic parameters with alirocumab vs. usual care treatment. * To demonstrate the safety and tolerability of alirocumab. * To evaluate treatment acceptance of alirocumab. * To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. * To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).
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Trial website
https://clinicaltrials.gov/study/NCT02642159
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Trial related presentations / publications
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3. Colhoun HM, Leiter LA, Muller-Wieland D, Cariou B, Ray KK, Tinahones FJ, Domenger C, Letierce A, Israel M, Samuel R, Del Prato S. Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol. Cardiovasc Diabetol. 2020 Feb 8;19(1):14. doi: 10.1186/s12933-020-0991-1. Ray KK, Del Prato S, Muller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9. Ray KK, Leiter LA, Muller-Wieland D, Cariou B, Colhoun HM, Henry RR, Tinahones FJ, Bujas-Bobanovic M, Domenger C, Letierce A, Samuel R, Del Prato S. Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial. Diabetes Obes Metab. 2018 Jun;20(6):1479-1489. doi: 10.1111/dom.13257. Epub 2018 Mar 23. Muller-Wieland D, Leiter LA, Cariou B, Letierce A, Colhoun HM, Del Prato S, Henry RR, Tinahones FJ, Aurand L, Maroni J, Ray KK, Bujas-Bobanovic M. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol. 2017 May 25;16(1):70. doi: 10.1186/s12933-017-0552-4.
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Public notes
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Contacts
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Sanofi
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No information has been provided regarding IPD availability
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/59/NCT02642159/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/59/NCT02642159/SAP_001.pdf
Results publications and other study-related documents
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Results not provided in
https://clinicaltrials.gov/study/NCT02642159
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