Trial · NCT02642159
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
NCT02642159, Phase 4, Completed, Sanofi; results first posted 2018-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia). Trials, record NCT02642159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02642159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
- NCT number
- NCT02642159
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 413 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Dyslipidemia
- Interventions
- Alirocumab, Statins, Ezetimibe, Fenofibrate, Nicotinic acid, Omega-3 fatty acids, Antihyperglycemic Drug
- First posted
- 2015-12-30
- Last updated
- 2018-05-01
- Other registries' IDs
- eudract:2015-001934-19
- Results first posted
- 2018-05-01
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Non-HDL-C at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). |
| Primary | Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | 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 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. |
| Secondary | Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | 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 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. |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis | From Baseline to Week 24 | 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. |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum | From Baseline to Week 24 | 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. |
| Secondary | Percent Change From Baseline in Measured LDL-C at Week 12: Overall 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 8 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum | 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 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. |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | 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 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
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 Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | ITT population: all randomized participants with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | From Baseline to Week 24 | ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis | From Baseline to Week 24 | 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). | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | From Baseline to Week 24 | LDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis | From Baseline to Week 24 | ITT population. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum | From Baseline to Week 24 | ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis | From Baseline to Week 24 | LDL-C ITT population. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum | From Baseline to Week 24 | LDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall 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 Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | From Baseline to Week 24 | Apo-B ITT population.Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group52
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 Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | -37.3 | Standard Error 3.0 | Percent change | |
| Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis | Usual Care | -4.7 | Standard Error 3.3 | Percent change | |
| Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | -41.7 | Standard Error 3.4 | Percent change | |
| Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Usual Care: Intent to Prescribe Fenofibrate | -8.5 | Standard Error 4.8 | Percent change | |
| Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | -43.3 | Standard Error 3.6 | Percent change | |
| Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis | Usual Care | -0.3 | Standard Error 4.0 | Percent change | |
| Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | -47.0 | Standard Error 4.2 | Percent change | |
| Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum | Usual Care: Intent to Prescribe Fenofibrate | 8.7 | Standard Error 5.8 | Percent change | |
| Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | -35.5 | Standard Error 2.9 | Percent change | |
| Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis | Usual Care | -9.4 | Standard Error 3.2 | Percent change |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
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 | 276 | |
| Overall Study | STARTED | Usual Care | 137 | |
| Overall Study | Treated (Safety Population) | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 275 | |
| Overall Study | Treated (Safety Population) | Usual Care | 137 | |
| Overall Study | ITT Population | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 273 | |
| Overall Study | ITT Population | Usual Care | 136 | |
| Overall Study | ITT: Intent to Prescribe Fenofibrate | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 47 | |
| Overall Study | ITT: Intent to Prescribe Fenofibrate | Usual Care | 24 | |
| Overall Study | COMPLETED | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 245 | |
| Overall Study | COMPLETED | Usual Care | 129 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events70
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 | Diarrhoea | Gastrointestinal disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 14 | 275 | |
| other | Diarrhoea | Gastrointestinal disorders | Usual Care | 9 | 137 | |
| other | Bronchitis | Infections and infestations | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 5 | 275 | |
| other | Bronchitis | Infections and infestations | Usual Care | 7 | 137 | |
| other | Urinary tract infection | Infections and infestations | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 15 | 275 | |
| other | Urinary tract infection | Infections and infestations | Usual Care | 5 | 137 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 6 | 275 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Usual Care | 8 | 137 | |
| serious | Acute myocardial infarction | Cardiac disorders | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 1 | 275 | |
| serious | Acute myocardial infarction | Cardiac disorders | Usual Care | 1 | 137 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 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 | 1 | 275 |
| Total, all-cause mortality | Usual Care | 0 | 137 |
| Total, other adverse events | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 37 | 275 |
| Total, other adverse events | Usual Care | 27 | 137 |
| Total, serious adverse events | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | 26 | 275 |
| Total, serious adverse events | Usual Care | 12 | 137 |
Source ClinicalTrials.gov
Papers5
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 Usual Care: deaths from any cause | Trial comparisons |
| Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: 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/NCT02642159
GET https://conductscience.org/api/trials/v1/NCT02642159/registered?page=2