Hypercholesterolaemia
Conditions
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.
Interventions
DRUGAlirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
DRUGPlacebo
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.
Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | 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) | From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 24 | 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 | From Baseline to Week 24 | 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 | From Baseline to Week 24 | 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 | From Baseline to Week 24 | 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 | From Baseline to Week 24 | 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 | Up to Week 24 | 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). |
| Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Baseline, Weeks 12 and 24 | Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline. |
| Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis | Up to Week 24 | 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 | Up to Week 24 | 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 | Up to Week 24 | 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 | From Baseline to Week 24 | 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 | From Baseline to Week 24 | 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 Calculated LDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 24 | 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 LDL-C Particle Number at Week 24 - ITT Analysis | From Baseline to Week 24 | 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 | From Baseline to Week 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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 | Baseline, Weeks 12 and 24 | 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. |
| Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | From Baseline to Week 24 | 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 Measured LDL-C at Week 24 - ITT Analysis | From Baseline to Week 24 | 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. |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 103 sites in 10 countries. Of these, 97 active sites randomized at least 1 participant. Overall 796 participants were screened between October 2015 and August 2016, of whom 279 were screen failures. Screen failures were mainly due to exclusion criteria met or inclusion criteria not met.
Pre-assignment details
Randomization was stratified by diabetes type (Type 1 diabetes mellitus \[T1DM\] versus Type 2 diabetes mellitus \[T2DM\]). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 ratio (Alirocumab:Placebo). A total of 517 participants were randomized. Baseline and efficacy data were analyzed per stratum.
Participants by arm
| Arm | Count |
|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants Alirocumab 75 mg 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. 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. | 51 |
| Placebo Q2W: T1DM Participants 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. | 25 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants Alirocumab 75 mg 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. 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. | 294 |
| Placebo Q2W: T2DM Participants 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. | 147 |
| Total | 517 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 17 | 4 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Other than specified above | 6 | 2 |
| Overall Study | Participant did not wish to continue | 9 | 4 |
| Overall Study | Poor compliance to study protocol | 0 | 2 |
| Overall Study | Randomized but not treated | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo Q2W: T1DM Participants | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Placebo Q2W: T2DM Participants | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 7.8 | 54.9 years STANDARD_DEVIATION 10.1 | 63.9 years STANDARD_DEVIATION 8.9 | 64.0 years STANDARD_DEVIATION 9.4 | 62.8 years STANDARD_DEVIATION 9.6 |
| Calculated LDL-C in mg/dL | 110.2 mg/dL STANDARD_DEVIATION 31.2 | 126.4 mg/dL STANDARD_DEVIATION 58.2 | 110.8 mg/dL STANDARD_DEVIATION 36.5 | 109.6 mg/dL STANDARD_DEVIATION 39.1 | 112.0 mg/dL STANDARD_DEVIATION 39.8 |
| Calculated LDL-C in mmol/L | 2.853 mmol/L STANDARD_DEVIATION 0.807 | 3.273 mmol/L STANDARD_DEVIATION 1.506 | 2.871 mmol/L STANDARD_DEVIATION 0.944 | 2.838 mmol/L STANDARD_DEVIATION 1.013 | 2.900 mmol/L STANDARD_DEVIATION 1.031 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 13 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 50 Participants | 280 Participants | 138 Participants | 493 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Oriental | 0 Participants | 0 Participants | 7 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 27 Participants | 7 Participants | 35 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White/Caucasian | 24 Participants | 50 Participants | 259 Participants | 135 Participants | 468 Participants |
| Sex: Female, Male Female | 8 Participants | 22 Participants | 133 Participants | 69 Participants | 232 Participants |
| Sex: Female, Male Male | 17 Participants | 29 Participants | 161 Participants | 78 Participants | 285 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 344 | 1 / 170 |
| other Total, other adverse events | 17 / 344 | 9 / 170 |
| serious Total, serious adverse events | 31 / 344 | 16 / 170 |
Outcome results
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).
Time frame: From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks)
Population: Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any AE | 64.5 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any Serious AE | 9.0 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any AE leading to death | 0 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any AE leading to treatment discontinuation | 4.9 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any AE leading to treatment discontinuation | 2.4 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any AE | 64.1 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any AE leading to death | 0.6 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Any Serious AE | 9.4 percentage of participants |
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).
Time frame: From Baseline to Week 24
Population: ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | -51.8 percent change | Standard Error 3.7 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | -3.9 percent change | Standard Error 5.3 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | -48.2 percent change | Standard Error 1.6 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | 0.8 percent change | Standard Error 2.2 |
Comparison: Alirocumab group was compared to placebo group using an appropriate contrast statement.p-value: <0.000195% CI: [-60.7, -35]Mixed Models Analysis
Comparison: Alirocumab group was compared to placebo group using an appropriate contrast statement.p-value: <0.000195% CI: [-54.4, -43.6]Mixed Models Analysis
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.
Time frame: Baseline, Weeks 12 and 24
Population: ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.23 mmol/L | Standard Deviation 4.44 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.52 mmol/L | Standard Deviation 5.2 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.81 mmol/L | Standard Deviation 4.21 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.45 mmol/L | Standard Deviation 4.73 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.25 mmol/L | Standard Deviation 2.73 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.52 mmol/L | Standard Deviation 3.43 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.13 mmol/L | Standard Deviation 2.73 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.55 mmol/L | Standard Deviation 2.62 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.23 mmol/L | Standard Deviation 4.44 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.38 mmol/L | Standard Deviation 5.24 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.71 mmol/L | Standard Deviation 4.19 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.45 mmol/L | Standard Deviation 4.73 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.22 mmol/L | Standard Deviation 2.7 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.52 mmol/L | Standard Deviation 3.47 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.15 mmol/L | Standard Deviation 2.74 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.48 mmol/L | Standard Deviation 2.53 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.00 percentage of hemoglobin | Standard Deviation 0.46 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | -0.03 percentage of hemoglobin | Standard Deviation 0.6 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | -0.23 percentage of hemoglobin | Standard Deviation 0.36 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | -0.22 percentage of hemoglobin | Standard Deviation 0.39 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | -0.04 percentage of hemoglobin | Standard Deviation 0.57 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.18 percentage of hemoglobin | Standard Deviation 0.74 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.00 percentage of hemoglobin | Standard Deviation 0.58 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.06 percentage of hemoglobin | Standard Deviation 0.66 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.00 percentage of hemoglobin | Standard Deviation 0.46 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | -0.05 percentage of hemoglobin | Standard Deviation 0.61 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | -0.27 percentage of hemoglobin | Standard Deviation 0.34 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | -0.22 percentage of hemoglobin | Standard Deviation 0.39 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | -0.04 percentage of hemoglobin | Standard Deviation 0.57 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.18 percentage of hemoglobin | Standard Deviation 0.74 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.00 percentage of hemoglobin | Standard Deviation 0.59 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.06 percentage of hemoglobin | Standard Deviation 0.67 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: ITT population . Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | -0.1 U/kg | Standard Deviation 0.5 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.0 U/kg | Standard Deviation 0.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.0 U/kg | Standard Deviation 0.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.2 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | -0.1 U/kg | Standard Deviation 0.5 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.0 U/kg | Standard Deviation 0.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.0 U/kg | Standard Deviation 0.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.0 U/kg | Standard Deviation 0.1 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0.0 U/kg | Standard Deviation 0.1 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0.3 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0.2 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0.2 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0.3 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0 glucose lowering treatments | Standard Deviation 0.2 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 0 glucose lowering treatments | Standard Deviation 0.2 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: ITT population . Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | -10.0 units (U) | Standard Deviation 48.7 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | -2.2 units (U) | Standard Deviation 11.3 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | -0.8 units (U) | Standard Deviation 9.8 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | -1.3 units (U) | Standard Deviation 9.6 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 0.2 units (U) | Standard Deviation 7.9 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 2.2 units (U) | Standard Deviation 14.8 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 12 | 1.4 units (U) | Standard Deviation 11.4 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis | Change at Week 24 | 1.6 units (U) | Standard Deviation 11.4 |
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.
Time frame: Baseline, Weeks 12 and 24
Population: mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | -10.0 units (U) | Standard Deviation 48.7 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | -2.2 units (U) | Standard Deviation 11.3 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | -0.8 units (U) | Standard Deviation 9.8 |
| Placebo Q2W: T1DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | -1.3 units (U) | Standard Deviation 9.6 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 0.2 units (U) | Standard Deviation 7.9 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 1.7 units (U) | Standard Deviation 11.7 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 12 | 1.4 units (U) | Standard Deviation 11.4 |
| Placebo Q2W: T2DM Participants | Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis | Change at Week 24 | 1.6 units (U) | Standard Deviation 11.5 |
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.
Time frame: Up to Week 24
Population: mITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis | 55.1 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis | 0 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis | 50.7 percentage of participants |
| Placebo Q2W: T2DM Participants | Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis | 2.7 percentage of participants |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).p-value: <0.000195% CI: [16.6, 168.3]Regression, Logistic
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).
Time frame: Up to Week 24
Population: mITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | 70.2 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | 5.1 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | 76.4 percentage of participants |
| Placebo Q2W: T2DM Participants | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | 7.4 percentage of participants |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [13.1, 1041.8]Regression, Logistic
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [36.5, 196.1]Regression, Logistic
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).
Time frame: Up to Week 24
Population: Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment (Non-HDL-C mITT population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis | 79.0 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis | 22.9 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis | 70.9 percentage of participants |
| Placebo Q2W: T2DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis | 13.8 percentage of participants |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [8, 137.4]Regression, Logistic
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [14.2, 51.5]Regression, Logistic
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).
Time frame: Up to Week 24
Population: Non-HDL-C mITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis | 59.6 percentage of participants |
| Placebo Q2W: T1DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis | 5.3 percentage of participants |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis | 52.3 percentage of participants |
| Placebo Q2W: T2DM Participants | Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis | 1.7 percentage of participants |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: 0.000295% CI: [6.5, 473.7]Regression, Logistic
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [24.6, 433.1]Regression, Logistic
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | -39.4 percent change | Standard Error 3 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | -0.4 percent change | Standard Error 4.3 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | -33.4 percent change | Standard Error 1.3 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | 3.3 percent change | Standard Error 1.7 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-49.4, -28.7]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-40.9, -32.5]Mixed Models Analysis
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment at Week 12 (ITT population at Week 12).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | -49.4 percent change | Standard Error 3.5 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | -4.5 percent change | Standard Error 5 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | -48.8 percent change | Standard Error 1.4 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | 1.4 percent change | Standard Error 2.1 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-56.9, -32.8]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-55.2, -45.3]Mixed Models Analysis
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).
Time frame: From Baseline to Week 24
Population: Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | -53.8 percent change | Standard Error 3.7 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | -3.2 percent change | Standard Error 5.3 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | -50.9 percent change | Standard Error 1.6 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | 0.7 percent change | Standard Error 2.2 |
Comparison: A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.p-value: <0.000195% CI: [-63.4, -37.9]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-56.9, -46.4]Mixed Models Analysis
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.
Time frame: From Baseline to Week 24
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | -13.6 percent change | Standard Error 4.7 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | 1.9 percent change | Standard Error 6.7 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | -5.7 percent change | Standard Error 2 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | 0.0 percent change | Standard Error 2.7 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: 0.090295% CI: [-12.3, 0.9]Regression, Robust
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | 11.2 percent change | Standard Error 2.4 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | 7.3 percent change | Standard Error 3.5 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | 8.1 percent change | Standard Error 1 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | 3.7 percent change | Standard Error 1.4 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: 0.343495% CI: [-4.2, 12]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: 0.0195% CI: [1.1, 7.7]Mixed Models Analysis
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number value on- or off-treatment (LDL-C particle number ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis | -44.4 percent change | Standard Error 3.2 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis | -4.4 percent change | Standard Error 4.6 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis | -38.3 percent change | Standard Error 1.3 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis | 1.9 percent change | Standard Error 1.9 |
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle size value on- or off-treatment (LDL-C particle size ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis | -2.3 percent change | Standard Error 0.3 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis | 0.8 percent change | Standard Error 0.5 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis | -2.8 percent change | Standard Error 0.1 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis | -0.3 percent change | Standard Error 0.2 |
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.
Time frame: From Baseline to Week 24
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | -23.0 percent change | Standard Error 3.8 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | -4.3 percent change | Standard Error 5.3 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | -19.0 percent change | Standard Error 1.6 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | -0.5 percent change | Standard Error 2.2 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: 0.003995% CI: [-31.4, -6]Regression, Robust
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-23.7, -13.2]Regression, Robust
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment at Week 12 (Measured LDL-C ITT population at Week 12).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis | -46.7 percent change | Standard Error 3.6 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis | -4.0 percent change | Standard Error 5.1 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis | -44.8 percent change | Standard Error 1.4 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis | -0.8 percent change | Standard Error 2 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-54.9, -30.5]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-49, -39.2]Mixed Models Analysis
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment (Measured LDL-C ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | -49.4 percent change | Standard Error 3.7 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | -1.1 percent change | Standard Error 5.4 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | -43.3 percent change | Standard Error 1.6 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | 2.4 percent change | Standard Error 2.2 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-61.2, -35.5]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-50.9, -40.4]Mixed Models Analysis
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | -45.9 percent change | Standard Error 3.3 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | -3.2 percent change | Standard Error 4.8 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | -37.9 percent change | Standard Error 1.4 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | 0.7 percent change | Standard Error 2 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-54.2, -31.3]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-43.4, -33.9]Mixed Models Analysis
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.
Time frame: From Baseline to Week 24
Population: Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (Total-C ITT population).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | -29.9 percent change | Standard Error 2.5 |
| Placebo Q2W: T1DM Participants | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | -0.7 percent change | Standard Error 3.6 |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | -26.8 percent change | Standard Error 1 |
| Placebo Q2W: T2DM Participants | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | 0.8 percent change | Standard Error 1.5 |
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-37.8, -20.7]Mixed Models Analysis
Comparison: Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).p-value: <0.000195% CI: [-31.2, -24.1]Mixed Models Analysis