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Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Primary Purpose

Hypercholesterolaemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Alirocumab

Placebo

Lipid-Modifying Therapy (LMT)

Antihyperglycemic Drug

About this trial

This is an interventional treatment trial for Hypercholesterolaemia

Eligibility Criteria

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

Inclusion criteria:

Participants diagnosed with Type 1 or Type 2 diabetes at least one year prior to the screening visit (Week -3).
Signed written informed consent
Participants with type 1 or type 2 diabetes treated with insulin whose LDL-C levels were not adequately controlled with maximally tolerated lipid-modifying therapy
LDL-C of 70 mg/dL or greater
18 years of age or more
Glycosylated hemoglobin (HbA1c) less than 10%
History of cardiovascular disease (including coronary heart disease [CHD] and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor

Exclusion criteria:

Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening or from screening to randomization, unless statin intolerant
Triglycerides >400 mg/dL
Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation
Currently received or planned to receive renal replacement therapy (for example, hemodialysis)
Change in weight of more than 5 kilograms within the prior 2 months
Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or planned to intensify insulin regimen during the study
Not treated with insulin for at least 6 months
Planned to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study
Body mass index (BMI) >45 kg/m² or planned to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study
History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis)

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Placebo Q2W

Arm Description

Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable, maximally tolerated dose of statin therapy with or without other lipid-modifying therapy (LMT), insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - 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 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)

Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).

Secondary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Measured LDL-C at Week 24 - 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 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Measured LDL-C at Week 12 - 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 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis

Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis

Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach (for T1DM participants) and multiple imputation approach model (for T2DM participants) including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). The maximum likelihood estimate did not exist as response rate was zero in a treatment group of T1DM participants.

Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis

Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis

Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach for handling of missing data followed by robust regression model. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.

Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 from multiple imputation approach for handling of missing data followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in LDL-C Particle Number at Week 24 - 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 4 to Week 24 regardless of status on- or off-treatment.

Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis

LDL-C particle size was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis

Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.

Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis

Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.

Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis

Absolute change = FPG value at specified weeks minus FPG value at baseline.

Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis

Absolute change = FPG value at specified weeks minus FPG value at baseline.

Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis

Absolute change = total daily insulin dose at specified weeks minus baseline value.

Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis

Absolute change = total daily insulin dose at specified weeks minus baseline value.

Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis

Absolute change = daily insulin dose/kg at specified weeks minus baseline value.

Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis

Absolute change = daily insulin dose/kg at specified weeks minus baseline value.

Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - 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 weeks minus baseline value.

Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis

Full Information

NCT ID

NCT02585778

First Posted

October 22, 2015

Last Updated

May 1, 2018

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02585778

Brief Title

Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated Patients With Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 23, 2015 (Actual)

Primary Completion Date

April 3, 2017 (Actual)

Study Completion Date

April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objectives: To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).

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.

6. Conditions and Keywords

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

Hypercholesterolaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

517 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Arm Type

Experimental

Arm Description

Arm Title

Placebo Q2W

Arm Type

Placebo Comparator

Arm Description

Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Alirocumab

Other Intervention Name(s)

Praluent, SAR236553, REGN727

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)

Placebo

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)

Lipid-Modifying Therapy (LMT)

Intervention Description

Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.

Intervention Type

Drug

Intervention Name(s)

Antihyperglycemic Drug

Intervention Description

Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)

Description

Time Frame

From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks)

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 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 Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 24

Title

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis

Description

Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Time Frame

Up to Week 24

Title

Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis

Description

Time Frame

Up to Week 24

Title

Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis

Description

Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Time Frame

Up to Week 24

Title

Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis

Description

Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).

Time Frame

Up to Week 24

Title

Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 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 Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 24

Title

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis

Description

Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis

Description

Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis

Description

Absolute change = FPG value at specified weeks minus FPG value at baseline.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis

Description

Absolute change = FPG value at specified weeks minus FPG value at baseline.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis

Description

Absolute change = total daily insulin dose at specified weeks minus baseline value.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis

Description

Absolute change = total daily insulin dose at specified weeks minus baseline value.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis

Description

Absolute change = daily insulin dose/kg at specified weeks minus baseline value.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis

Description

Absolute change = daily insulin dose/kg at specified weeks minus baseline value.

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis

Description

Time Frame

Baseline, Weeks 12 and 24

Title

Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis

Description

Time Frame

Baseline, Weeks 12 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants diagnosed with Type 1 or Type 2 diabetes at least one year prior to the screening visit (Week -3). Signed written informed consent Participants with type 1 or type 2 diabetes treated with insulin whose LDL-C levels were not adequately controlled with maximally tolerated lipid-modifying therapy LDL-C of 70 mg/dL or greater 18 years of age or more Glycosylated hemoglobin (HbA1c) less than 10% History of cardiovascular disease (including coronary heart disease [CHD] and/or CHD risk equivalents) and/or at least one additional cardiovascular risk factor Exclusion criteria: Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening or from screening to randomization, unless statin intolerant Triglycerides >400 mg/dL Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation Currently received or planned to receive renal replacement therapy (for example, hemodialysis) Change in weight of more than 5 kilograms within the prior 2 months Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or planned to intensify insulin regimen during the study Not treated with insulin for at least 6 months Planned to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study Body mass index (BMI) >45 kg/m² or planned to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis) 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 840020

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Investigational Site Number 840002

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 840029

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Name

Investigational Site Number 840027

City

Loveland

State/Province

Colorado

ZIP/Postal Code

80538

Country

United States

Facility Name

Investigational Site Number 840026

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Investigational Site Number 840006

City

Bradenton

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Investigational Site Number 840023

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Investigational Site Number 840028

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 840022

City

Ponte Vedra Beach

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840021

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Investigational Site Number 840007

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Investigational Site Number 840011

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Investigational Site Number 840015

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Investigational Site Number 840010

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Investigational Site Number 840005

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

Investigational Site Number 840018

City

Auburn

State/Province

Maine

ZIP/Postal Code

04210

Country

United States

Facility Name

Investigational Site Number 840013

City

Hyattsville

State/Province

Maryland

ZIP/Postal Code

20782

Country

United States

Facility Name

Investigational Site Number 840016

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Investigational Site Number 840004

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Investigational Site Number 840012

City

Jamaica

State/Province

New York

ZIP/Postal Code

11432

Country

United States

Facility Name

Investigational Site Number 840014

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Investigational Site Number 840009

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Investigational Site Number 840024

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Investigational Site Number 840001

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

Investigational Site Number 840003

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 840019

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Investigational Site Number 840025

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Investigational Site Number 840017

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Investigational Site Number 840008

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Investigational Site Number 040002

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Investigational Site Number 040005

City

Linz

ZIP/Postal Code

4021

Country

Austria

Facility Name

Investigational Site Number 040003

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Investigational Site Number 040004

City

Salzburg

ZIP/Postal Code

5026

Country

Austria

Facility Name

Investigational Site Number 040001

City

Wien

ZIP/Postal Code

1160

Country

Austria

Facility Name

Investigational Site Number 056002

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Investigational Site Number 056003

City

Haine-Saint-Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 250-008

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Investigational Site Number 250-005

City

Corbeil Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Investigational Site Number 250-004

City

La Rochelle Cedex 1

ZIP/Postal Code

17019

Country

France

Facility Name

Investigational Site Number 250-003

City

Le Creusot

ZIP/Postal Code

71200

Country

France

Facility Name

Investigational Site Number 250-009

City

Mulhouse

Country

France

Facility Name

Investigational Site Number 250-002

City

Nantes cedex 01

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 250-007

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Investigational Site Number 250-006

City

Strasbourg Cedex 2

ZIP/Postal Code

67098

Country

France

Facility Name

Investigational Site Number 250-001

City

TOULOUSE Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Investigational Site Number 276015

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Investigational Site Number 276002

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Investigational Site Number 276011

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Investigational Site Number 276019

City

Dresden

ZIP/Postal Code

01099

Country

Germany

Facility Name

Investigational Site Number 276014

City

Dresden

ZIP/Postal Code

01279

Country

Germany

Facility Name

Investigational Site Number 276009

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Investigational Site Number 276021

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Investigational Site Number 276018

City

Hamburg

ZIP/Postal Code

22041

Country

Germany

Facility Name

Investigational Site Number 276005

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Investigational Site Number 276013

City

Lüneburg

ZIP/Postal Code

21339

Country

Germany

Facility Name

Investigational Site Number 276022

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Investigational Site Number 276008

City

Neumünster

ZIP/Postal Code

24534

Country

Germany

Facility Name

Investigational Site Number 276017

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Investigational Site Number 276004

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Investigational Site Number 276003

City

Pirna

ZIP/Postal Code

01796

Country

Germany

Facility Name

Investigational Site Number 276006

City

Riesa

ZIP/Postal Code

01587

Country

Germany

Facility Name

Investigational Site Number 276010

City

Saarlouis

ZIP/Postal Code

66740

Country

Germany

Facility Name

Investigational Site Number 276016

City

Sulzbach-Rosenberg

ZIP/Postal Code

92237

Country

Germany

Facility Name

Investigational Site Number 380004

City

Catania

ZIP/Postal Code

95122

Country

Italy

Facility Name

Investigational Site Number 380003

City

Catanzaro

Country

Italy

Facility Name

Investigational Site Number 380011

City

Como

ZIP/Postal Code

22100

Country

Italy

Facility Name

Investigational Site Number 380006

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 380007

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Investigational Site Number 380005

City

Moncalieri

ZIP/Postal Code

10024

Country

Italy

Facility Name

Investigational Site Number 380009

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Investigational Site Number 380008

City

Padova

Country

Italy

Facility Name

Investigational Site Number 380002

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Investigational Site Number 380001

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Investigational Site Number 380010

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Investigational Site Number 380012

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Investigational Site Number 528002

City

Apeldoorn

ZIP/Postal Code

7334 DZ

Country

Netherlands

Facility Name

Investigational Site Number 528005

City

Groningen

Country

Netherlands

Facility Name

Investigational Site Number 528003

City

Hoogeveen

ZIP/Postal Code

7909AA

Country

Netherlands

Facility Name

Investigational Site Number 528001

City

Rotterdam

ZIP/Postal Code

3045PM

Country

Netherlands

Facility Name

Investigational Site Number 528004

City

Utrecht

Country

Netherlands

Facility Name

Investigational Site Number 724007

City

Badalona

ZIP/Postal Code

08915

Country

Spain

Facility Name

Investigational Site Number 724001

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Investigational Site Number 724006

City

Ferrol

ZIP/Postal Code

15405

Country

Spain

Facility Name

Investigational Site Number 724013

City

Granada

ZIP/Postal Code

18003

Country

Spain

Facility Name

Investigational Site Number 724005

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Investigational Site Number 724004

City

Madrid

Country

Spain

Facility Name

Investigational Site Number 724011

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

Investigational Site Number 724008

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724014

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Investigational Site Number 724009

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

Investigational Site Number 724002

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Investigational Site Number 724010

City

Sant Joan Despí

ZIP/Postal Code

08970

Country

Spain

Facility Name

Investigational Site Number 724012

City

Segovia

Country

Spain

Facility Name

Investigational Site Number 724003

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 756001

City

Olten

ZIP/Postal Code

4600

Country

Switzerland

Facility Name

Investigational Site Number 756003

City

St. Gallen

ZIP/Postal Code

9016

Country

Switzerland

Facility Name

Investigational Site Number 826010

City

Airdrie

ZIP/Postal Code

ML60JS

Country

United Kingdom

Facility Name

Investigational Site Number 826011

City

Bath

ZIP/Postal Code

BA13NG

Country

United Kingdom

Facility Name

Investigational Site Number 826009

City

Bournemouth

ZIP/Postal Code

BH77DW

Country

United Kingdom

Facility Name

Investigational Site Number 826005

City

Bradford

ZIP/Postal Code

BD96RJ

Country

United Kingdom

Facility Name

Investigational Site Number 826004

City

Bristol

ZIP/Postal Code

BS28HW

Country

United Kingdom

Facility Name

Investigational Site Number 826001

City

Burton On Trent

ZIP/Postal Code

DE13 0RB

Country

United Kingdom

Facility Name

Investigational Site Number 826015

City

Durham

ZIP/Postal Code

DH15TW

Country

United Kingdom

Facility Name

Investigational Site Number 826012

City

High Wycombe

ZIP/Postal Code

HP112TT

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Manchester

ZIP/Postal Code

M239LT

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

Peterborough

ZIP/Postal Code

PE39QZ

Country

United Kingdom

Facility Name

Investigational Site Number 826003

City

Southampton

ZIP/Postal Code

SO303JB

Country

United Kingdom

Facility Name

Investigational Site Number 826008

City

Truro

ZIP/Postal Code

TR13LJ

Country

United Kingdom

Facility Name

Investigational Site Number 826002

City

Welwyn Garden City

ZIP/Postal Code

AL74HQ

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

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

28905478

Citation

Leiter LA, Cariou B, Muller-Wieland D, Colhoun HM, Del Prato S, Tinahones FJ, Ray KK, Bujas-Bobanovic M, Domenger C, Mandel J, Samuel R, Henry RR. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017 Dec;19(12):1781-1792. doi: 10.1111/dom.13114. Epub 2017 Oct 10.

Results Reference

derived

Learn more about this trial

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Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Hypercholesterolaemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial