| 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). | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00049
- OG00125
- OG002287
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-51.8± 3.7
- OG001-3.9± 5.3
- OG002-48.2± 1.6
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Alirocumab group was compared to placebo group using an appropriate contrast statement. | Mixed Models Analysis | | <0.0001 | Threshold for significance at 0.05 level. | LS Mean Difference | -47.8 | | | 2-Sided | 95 | -60.7 | -35.0 | | | | | Superiority | | | |
|
| 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). | Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated). | Posted | | Number | | percentage of participants | | From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 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. | | OG001 | Placebo Q2W | 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. |
| |
| 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). | Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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). | | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants |
|
| 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). | 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). | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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). | Non-HDL-C mITT population. | Posted | | Number | | percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | | Posted | | Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants |
|
| 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. | 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). | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants |
|
| 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. | ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | percentage of hemoglobin | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | percentage of hemoglobin | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | ITT population . Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | units (U) | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | units (U) | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | ITT population . Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | U/kg | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | U/kg | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | glucose lowering treatments | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | |
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| 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. | | Posted | | Mean | Standard Deviation | glucose lowering treatments | | Baseline, Weeks 12 and 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | |
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