Trial · NCT02585778
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
NCT02585778, Phase 3, Completed, Sanofi; results first posted 2018-05-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin). Trials, record NCT02585778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02585778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
- NCT number
- NCT02585778
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 517 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Hypercholesterolaemia
- Interventions
- Alirocumab, Placebo, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
- First posted
- 2015-10-23
- Last updated
- 2018-05-17
- Other registries' IDs
- eudract:2015-000799-92
- Results first posted
- 2018-05-17
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | 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 | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | 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) | Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated). | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 24 | Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | From Baseline to Week 24 | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 24 | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis | From Baseline to Week 24 | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 24 | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | From Baseline to Week 24 | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | From Baseline to Week 24 | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | Up to Week 24 | mITT population. | percentage of participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T1DM Participants | -51.8 | Standard Error 3.7 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Placebo Q2W: T1DM Participants | -3.9 | Standard Error 5.3 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Alirocumab 75 mg Q2W/Up to 150 mg Q2W: T2DM Participants | -48.2 | Standard Error 1.6 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Placebo Q2W: T2DM Participants | 0.8 | Standard Error 2.2 | percent change | |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Any AE | 64.5 | percentage of participants | |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Placebo Q2W | Any AE | 64.1 | percentage of participants | |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Any Serious AE | 9.0 | percentage of participants | |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Placebo Q2W | Any Serious AE | 9.4 | percentage of participants | |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Any AE leading to death | 0 | percentage of participants | |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) | Placebo Q2W | Any AE leading to death | 0.6 | percentage of participants |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 345 | |
| Overall Study | STARTED | Placebo Q2W | 172 | |
| Overall Study | Treated (Safety Population) | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 344 | |
| Overall Study | Treated (Safety Population) | Placebo Q2W | 170 | |
| Overall Study | ITT Population | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 336 | |
| Overall Study | ITT Population | Placebo Q2W | 167 | |
| Overall Study | mITT Population | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 333 | |
| Overall Study | mITT Population | Placebo Q2W | 164 | |
| Overall Study | T1DM Participants | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 51 | |
| Overall Study | T1DM Participants | Placebo Q2W | 25 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 17 | 344 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Q2W | 9 | 170 | |
| serious | Eosinophilia | Blood and lymphatic system disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 1 | 344 | |
| serious | Eosinophilia | Blood and lymphatic system disorders | Placebo Q2W | 0 | 170 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 0 | 344 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Placebo Q2W | 1 | 170 | |
| serious | Acute myocardial infarction | Cardiac disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 0 | 344 | |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo Q2W | 1 | 170 | |
| serious | Angina pectoris | Cardiac disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 1 | 344 | |
| serious | Angina pectoris | Cardiac disorders | Placebo Q2W | 0 | 170 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 0 | 344 |
| Total, all-cause mortality | Placebo Q2W | 1 | 170 |
| Total, other adverse events | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 17 | 344 |
| Total, other adverse events | Placebo Q2W | 9 | 170 |
| Total, serious adverse events | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 31 | 344 |
| Total, serious adverse events | Placebo Q2W | 16 | 170 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Placebo Q2W: deaths from any cause | Trial comparisons |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Placebo Q2W: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02585778
GET https://conductscience.org/api/trials/v1/NCT02585778/registered?page=2