| Primary | Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis | Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). | ITT population: all randomized participants with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-37.3± 3.0
- OG001-4.7± 3.3
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| | 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 |
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| Alirocumab group was compared to usual care group using an appropriate contrast statement. | Mixed Models Analysis | | <0.0001 | Threshold for significance <=0.025. | LS Mean Difference | -32.5 | | | 2-Sided | 97.5 | -38.1 | -27.0 | | | Alirocumab vs. usual care | | Superiority | | |
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| Primary | Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis | Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline LDL-C value on-or off-treatment (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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | LDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis | Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum | Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | LDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | Apo-B ITT population.Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | Total-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis | Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model. | | Posted | | Mean | Standard Error | Percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Posted | | Mean | Standard Error | Percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | | Posted | | Mean | Standard Error | Percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Posted | | Mean | Standard Error | Percent change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | HDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis | LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate. | LDL-C particle number ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | 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 | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care: Intent to Prescribe Fenofibrate | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks. |
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| Secondary | Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis | Absolute change = HbA1c value at specified week minus HbA1c value at baseline. | ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | mmol/mol | | Baseline, Week 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis | Absolute change = FPG value at specified week minus FPG value at baseline. | 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, Week 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
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| Secondary | Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis | Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value. | ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively. | Posted | | Mean | Standard Deviation | Glucose lowering treatments | | Baseline, Week 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels >=100 mg/dL (2.59 mmol/L) at Week 8. | | OG001 | Usual Care | Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks. |
| |