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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)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Alirocumab
Statins
Ezetimibe
Fenofibrate
Nicotinic acid
Omega-3 fatty acids
Antihyperglycemic Drug
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840-163
  • Investigational Site Number 840-141
  • Investigational Site Number 840-152
  • Investigational Site Number 840-115
  • Investigational Site Number 840-118
  • Investigational Site Number 840-106
  • Investigational Site Number 840-176
  • Investigational Site Number 840-122
  • Investigational Site Number 840-156
  • Investigational Site Number 840-160
  • Investigational Site Number 840-107
  • Investigational Site Number 840-170
  • Investigational Site Number 840-114
  • Investigational Site Number 840-132
  • Investigational Site Number 840-179
  • Investigational Site Number 840-123
  • Investigational Site Number 840-137
  • Investigational Site Number 840-128
  • Investigational Site Number 840-169
  • Investigational Site Number 840-167
  • Investigational Site Number 840-161
  • Investigational Site Number 840-184
  • Investigational Site Number 840-174
  • Investigational Site Number 840-138
  • Investigational Site Number 840-108
  • Investigational Site Number 840-183
  • Investigational Site Number 840-190
  • Investigational Site Number 840-151
  • Investigational Site Number 840-113
  • Investigational Site Number 840-120
  • Investigational Site Number 840-148
  • Investigational Site Number 840-101
  • Investigational Site Number 840-140
  • Investigational Site Number 840-178
  • Investigational Site Number 840-181
  • Investigational Site Number 840-157
  • Investigational Site Number 840-188
  • Investigational Site Number 840-131
  • Investigational Site Number 840-158
  • Investigational Site Number 840-129
  • Investigational Site Number 840-104
  • Investigational Site Number 840-105
  • Investigational Site Number 840-175
  • Investigational Site Number 840-136
  • Investigational Site Number 840-187
  • Investigational Site Number 840-111
  • Investigational Site Number 840-147
  • Investigational Site Number 840-159
  • Investigational Site Number 840-153
  • Investigational Site Number 840-143
  • Investigational Site Number 840-168
  • Investigational Site Number 840-142
  • Investigational Site Number 840-133
  • Investigational Site Number 840-185
  • Investigational Site Number 840-150
  • Investigational Site Number 840-126
  • Investigational Site Number 840-171
  • Investigational Site Number 036102
  • Investigational Site Number 036104
  • Investigational Site Number 036101
  • Investigational Site Number 076103
  • Investigational Site Number 076104
  • Investigational Site Number 076101
  • Investigational Site Number 076105
  • Investigational Site Number 076106
  • Investigational Site Number 076102
  • Investigational Site Number 246102
  • Investigational Site Number 246101
  • Investigational Site Number 246104
  • Investigational Site Number 276112
  • Investigational Site Number 276109
  • Investigational Site Number 276104
  • Investigational Site Number 276101
  • Investigational Site Number 276110
  • Investigational Site Number 276108
  • Investigational Site Number 276111
  • Investigational Site Number 276107
  • Investigational Site Number 276103
  • Investigational Site Number 276102
  • Investigational Site Number 376101
  • Investigational Site Number 376103
  • Investigational Site Number 376104
  • Investigational Site Number 376102
  • Investigational Site Number 376106
  • Investigational Site Number 380104
  • Investigational Site Number 380107
  • Investigational Site Number 380103
  • Investigational Site Number 380108
  • Investigational Site Number 380106
  • Investigational Site Number 380101
  • Investigational Site Number 380105
  • Investigational Site Number 380102
  • Investigational Site Number 414101
  • Investigational Site Number 422101
  • Investigational Site Number 422102
  • Investigational Site Number 578101
  • Investigational Site Number 578102
  • Investigational Site Number 752102
  • Investigational Site Number 752101
  • Investigational Site Number 756101
  • Investigational Site Number 756102
  • Investigational Site Number 756103
  • Investigational Site Number 792105
  • Investigational Site Number 792106
  • Investigational Site Number 792102
  • Investigational Site Number 792108
  • Investigational Site Number 792109
  • Investigational Site Number 792104
  • Investigational Site Number 792101
  • Investigational Site Number 792110
  • Investigational Site Number 792107
  • Investigational Site Number 792103
  • Investigational Site Number 784101
  • Investigational Site Number 826104
  • Investigational Site Number 826106
  • Investigational Site Number 826105
  • Investigational Site Number 826103
  • Investigational Site Number 826101
  • Investigational Site Number 826102

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis
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).
Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.

Secondary Outcome Measures

Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis
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.
Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis
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.
Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis
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.
Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis
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.
Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis
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.
Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis
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.
Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis
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.
Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis
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.
Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis
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.
Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
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.
Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis
Absolute change = HbA1c value at specified week minus HbA1c value at baseline.
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis
Absolute change = FPG value at specified week minus FPG value at baseline.
Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis
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.

Full Information

First Posted
December 24, 2015
Last Updated
April 30, 2018
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02642159
Brief 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)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (undefined)
Primary Completion Date
March 22, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The maximum study duration was approximately 9 months per participant, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period. For the purpose of scientific communication, a first-step analysis (both efficacy and safety) was performed at the Week 24 cut-off date. A second-step analysis was performed once all participants had completed the study to include a final update of the safety analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
SAR236553, REGN727, Praluent
Intervention Description
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Intervention Type
Drug
Intervention Name(s)
Statins
Intervention Description
Statins at stable dose without other LMT as clinically indicated.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Nicotinic acid
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Antihyperglycemic Drug
Intervention Description
Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis
Description
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).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Description
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.
Time Frame
From Baseline to Week 24
Title
Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis
Description
Absolute change = HbA1c value at specified week minus HbA1c value at baseline.
Time Frame
Baseline, Week 12 and 24
Title
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis
Description
Absolute change = FPG value at specified week minus FPG value at baseline.
Time Frame
Baseline, Week 12 and 24
Title
Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis
Description
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.
Time Frame
Baseline, Week 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840-163
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 840-141
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site Number 840-152
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Investigational Site Number 840-115
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840-118
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Investigational Site Number 840-106
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Investigational Site Number 840-176
City
Port Hueneme
State/Province
California
ZIP/Postal Code
93041
Country
United States
Facility Name
Investigational Site Number 840-122
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Investigational Site Number 840-156
City
Tustin
State/Province
California
ZIP/Postal Code
92780-6953
Country
United States
Facility Name
Investigational Site Number 840-160
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Investigational Site Number 840-107
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Investigational Site Number 840-170
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Investigational Site Number 840-114
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Investigational Site Number 840-132
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Investigational Site Number 840-179
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Investigational Site Number 840-123
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Investigational Site Number 840-137
City
Bainbridge
State/Province
Georgia
ZIP/Postal Code
39819
Country
United States
Facility Name
Investigational Site Number 840-128
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigational Site Number 840-169
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Investigational Site Number 840-167
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840-161
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Investigational Site Number 840-184
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Investigational Site Number 840-174
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Investigational Site Number 840-138
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Investigational Site Number 840-108
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Investigational Site Number 840-183
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Investigational Site Number 840-190
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigational Site Number 840-151
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840-113
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Investigational Site Number 840-120
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number 840-148
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2137
Country
United States
Facility Name
Investigational Site Number 840-101
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigational Site Number 840-140
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Investigational Site Number 840-178
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Investigational Site Number 840-181
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Investigational Site Number 840-157
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Investigational Site Number 840-188
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Investigational Site Number 840-131
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Investigational Site Number 840-158
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Investigational Site Number 840-129
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Investigational Site Number 840-104
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Investigational Site Number 840-105
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Investigational Site Number 840-175
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Investigational Site Number 840-136
City
Bend
State/Province
Oregon
ZIP/Postal Code
97702
Country
United States
Facility Name
Investigational Site Number 840-187
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576-9351
Country
United States
Facility Name
Investigational Site Number 840-111
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Investigational Site Number 840-147
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Investigational Site Number 840-159
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Investigational Site Number 840-153
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840-143
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
Investigational Site Number 840-168
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Investigational Site Number 840-142
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Investigational Site Number 840-133
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Investigational Site Number 840-185
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Investigational Site Number 840-150
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Investigational Site Number 840-126
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Investigational Site Number 840-171
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Investigational Site Number 036102
City
Herston
ZIP/Postal Code
4006
Country
Australia
Facility Name
Investigational Site Number 036104
City
Merewether
ZIP/Postal Code
2291
Country
Australia
Facility Name
Investigational Site Number 036101
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Investigational Site Number 076103
City
Campinas
ZIP/Postal Code
13060080
Country
Brazil
Facility Name
Investigational Site Number 076104
City
Fortaleza
ZIP/Postal Code
60115-282
Country
Brazil
Facility Name
Investigational Site Number 076101
City
Sao Paulo
ZIP/Postal Code
04040-001
Country
Brazil
Facility Name
Investigational Site Number 076105
City
São paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
Investigational Site Number 076106
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Investigational Site Number 076102
City
SãO Paulo
Country
Brazil
Facility Name
Investigational Site Number 246102
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Investigational Site Number 246101
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Investigational Site Number 246104
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Investigational Site Number 276112
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Investigational Site Number 276109
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigational Site Number 276104
City
Dippoldiswalde
ZIP/Postal Code
01744
Country
Germany
Facility Name
Investigational Site Number 276101
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number 276110
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Investigational Site Number 276108
City
Essen
ZIP/Postal Code
45359
Country
Germany
Facility Name
Investigational Site Number 276111
City
Goch
ZIP/Postal Code
47574
Country
Germany
Facility Name
Investigational Site Number 276107
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Investigational Site Number 276103
City
Künzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Investigational Site Number 276102
City
Oldenburg in Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Investigational Site Number 376101
City
Beer Sheva
Country
Israel
Facility Name
Investigational Site Number 376103
City
Petach Tikva
Country
Israel
Facility Name
Investigational Site Number 376104
City
Petach tikva
Country
Israel
Facility Name
Investigational Site Number 376102
City
Rehovot
Country
Israel
Facility Name
Investigational Site Number 376106
City
Tel-Aviv
Country
Israel
Facility Name
Investigational Site Number 380104
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Investigational Site Number 380107
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Investigational Site Number 380103
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number 380108
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
Investigational Site Number 380106
City
Partinico
ZIP/Postal Code
90047
Country
Italy
Facility Name
Investigational Site Number 380101
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Investigational Site Number 380105
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Investigational Site Number 380102
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Investigational Site Number 414101
City
Kuwait
Country
Kuwait
Facility Name
Investigational Site Number 422101
City
Beirut
Country
Lebanon
Facility Name
Investigational Site Number 422102
City
Hazmieh
Country
Lebanon
Facility Name
Investigational Site Number 578101
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Investigational Site Number 578102
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Investigational Site Number 752102
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Investigational Site Number 752101
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Investigational Site Number 756101
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Investigational Site Number 756102
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Investigational Site Number 756103
City
Reinach
ZIP/Postal Code
4153
Country
Switzerland
Facility Name
Investigational Site Number 792105
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Investigational Site Number 792106
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Investigational Site Number 792102
City
Ankara
Country
Turkey
Facility Name
Investigational Site Number 792108
City
Corum
Country
Turkey
Facility Name
Investigational Site Number 792109
City
Hatay
ZIP/Postal Code
31030
Country
Turkey
Facility Name
Investigational Site Number 792104
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Investigational Site Number 792101
City
Izmir
Country
Turkey
Facility Name
Investigational Site Number 792110
City
Izmir
Country
Turkey
Facility Name
Investigational Site Number 792107
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Investigational Site Number 792103
City
Samsun
Country
Turkey
Facility Name
Investigational Site Number 784101
City
Dubai
ZIP/Postal Code
4545
Country
United Arab Emirates
Facility Name
Investigational Site Number 826104
City
Exeter
ZIP/Postal Code
EX25DW
Country
United Kingdom
Facility Name
Investigational Site Number 826106
City
Manchester
ZIP/Postal Code
m139wl
Country
United Kingdom
Facility Name
Investigational Site Number 826105
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Investigational Site Number 826103
City
Stevenage
ZIP/Postal Code
SG14AB
Country
United Kingdom
Facility Name
Investigational Site Number 826101
City
Torquay
ZIP/Postal Code
TQ27AA
Country
United Kingdom
Facility Name
Investigational Site Number 826102
City
West Bromwich
ZIP/Postal Code
B714HJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33078867
Citation
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.
Results Reference
derived
PubMed Identifier
32035487
Citation
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.
Results Reference
derived
PubMed Identifier
31706300
Citation
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.
Results Reference
derived
PubMed Identifier
29436756
Citation
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.
Results Reference
derived
PubMed Identifier
28545518
Citation
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.
Results Reference
derived

Learn more about this trial

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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