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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02585778
Other study ID # LPS14355
Secondary ID 2015-000799-92U1
Status Completed
Phase Phase 3
First received
Last updated
Start date October 23, 2015
Est. completion date April 3, 2017

Study information

Verified date April 2018
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Placebo
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Lipid-Modifying Therapy (LMT)
Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.
Antihyperglycemic Drug
Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.

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Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). From Baseline to Week 24
Primary 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). From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks)
Secondary 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). From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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). Up to Week 24
Secondary 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. Up to Week 24
Secondary 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). Up to Week 24
Secondary 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). Up to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. From Baseline to Week 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary 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. Baseline, Weeks 12 and 24
Secondary Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment 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. Baseline, Weeks 12 and 24
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