Trial record 1 of 1 for:
LPS14354
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)
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ClinicalTrials.gov Identifier: NCT02642159 |
Recruitment Status :
Completed
First Posted : December 30, 2015
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Dyslipidemia |
Interventions |
Drug: Alirocumab Drug: Statins Drug: Ezetimibe Drug: Fenofibrate Drug: Nicotinic acid Drug: Omega-3 fatty acids Drug: Antihyperglycemic Drug |
Enrollment | 413 |
Participant Flow
Recruitment Details | The study was conducted at 119 centers in 15 countries. A total of 864 participants were screened between March 2016 and September 2016, 451 of whom were screen failures. Screen failures were mainly due to inclusion criteria not met. |
Pre-assignment Details | Randomization was stratified by investigator's choice of usual care therapy, which was pre-specified prior to randomization. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 ratio (alirocumab: usual care) after confirmation of selection criteria. 413 participants were randomized. |
Arm/Group Title | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Usual Care |
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Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapies (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels >=100 mg/dL (2.59 mmol/L) at Week 8. | 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. |
Period Title: Overall Study | ||
Started | 276 [1] | 137 [1] |
Treated (Safety Population) | 275 | 137 |
ITT Population | 273 | 136 |
ITT: Intent to Prescribe Fenofibrate | 47 [2] | 24 |
Completed [3] | 245 | 129 |
Not Completed | 31 | 8 |
Reason Not Completed | ||
Randomized but not treated | 1 | 0 |
Adverse Event | 10 | 4 |
Withdrawal by Subject | 9 | 1 |
Poor compliance to study protocol | 1 | 0 |
Other than specified above | 10 | 3 |
[1]
Randomized
[2]
Fenofibrate was only 'intended to prescribe' in the Alirocumab arm but not actually administered.
[3]
Completed = treatment completion
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Baseline Characteristics
Arm/Group Title | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Usual Care | Total | |
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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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 276 | 137 | 413 | |
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Baseline population included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 276 participants | 137 participants | 413 participants | |
62.8 (9.3) | 64.1 (8.8) | 63.2 (9.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 276 participants | 137 participants | 413 participants | |
Female |
129 46.7%
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68 49.6%
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197 47.7%
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Male |
147 53.3%
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69 50.4%
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216 52.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 276 participants | 137 participants | 413 participants | |
Hispanic or Latino |
35 12.7%
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14 10.2%
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49 11.9%
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Not Hispanic or Latino |
240 87.0%
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123 89.8%
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363 87.9%
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Unknown or Not Reported |
1 0.4%
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0 0.0%
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1 0.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 276 participants | 137 participants | 413 participants |
White/Caucasian |
247 89.5%
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123 89.8%
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370 89.6%
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Black |
16 5.8%
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6 4.4%
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22 5.3%
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Asian/Oriental |
3 1.1%
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7 5.1%
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10 2.4%
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American Indian or Alaska Native |
4 1.4%
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0 0.0%
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4 1.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Other |
6 2.2%
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1 0.7%
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7 1.7%
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Non-HDL-C
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
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Number Analyzed | 276 participants | 137 participants | 413 participants | |
155.1 (46.2) | 161.5 (48.8) | 157.2 (47.1) | ||
[1]
Measure Description: non-HDL-C = Total cholesterol (Total-C) minus high-density lipoprotein cholesterol (HDL-C)
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Non-HDL-C
[1] Mean (Standard Deviation) Unit of measure: mmol/L |
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Number Analyzed | 276 participants | 137 participants | 413 participants | |
4.0 (1.2) | 4.2 (1.2) | 4.073 (1.221) | ||
[1]
Measure Description: non-HDL-C = Total-C minus HDL-C
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Intent to Prescribe Treatment
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 276 participants | 137 participants | 413 participants | |
Fenofibrate |
48 17.4%
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24 17.5%
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72 17.4%
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No additional LMT |
79 28.6%
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39 28.5%
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118 28.6%
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Ezetimibe |
104 37.7%
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52 38.0%
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156 37.8%
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Omega-3 fatty acids |
43 15.6%
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21 15.3%
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64 15.5%
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Nicotinic acid |
2 0.7%
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1 0.7%
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3 0.7%
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[1]
Measure Description: Randomization was stratified by the Investigator's selection of usual care therapy prior to randomization. LMTs were only 'intended to prescribe' in the Alirocumab arm but not actually administered.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02642159 |
Other Study ID Numbers: |
LPS14354 2015-001934-19 ( EudraCT Number ) U1111-1172-5262 ( Other Identifier: UTN ) |
First Submitted: | December 24, 2015 |
First Posted: | December 30, 2015 |
Results First Submitted: | March 20, 2018 |
Results First Posted: | May 1, 2018 |
Last Update Posted: | May 1, 2018 |