Trial · NCT02662569

Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia

NCT02662569, Phase 3, Completed, Amgen; results first posted 2019-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia. Trials, record NCT02662569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02662569

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
NCT number: NCT02662569
Status: Completed
Phases: Phase 3
Enrollment: 986 participants, actual
Lead sponsor: Amgen
Conditions: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Interventions: Evolocumab, Atorvastatin, Placebo
First posted: 2016-01-25
Last updated: 2019-01-11
Other registries' IDs: eudract:2013-000723-14
Results first posted: 2019-01-11

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Primary	Percent Change From Baseline in LDL-C at Week 12	Baseline and week 12
Secondary	Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Change From Baseline in LDL-C at Week 12	Baseline and week 12
Secondary	Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Non-HDL-C at Week 12	Baseline and week 12
Secondary	Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Apolipoprotein B100 at Week 12	Baseline and week 12
Secondary	Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Total Cholesterol at Week 12	Baseline and week 12

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

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 LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
PRIMARY	Percent Change From Baseline in LDL-C at Week 12	Baseline and week 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Full analysis set	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in LDL-C at Week 12	Baseline and week 12	Full analysis set	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Non-HDL-C at Week 12	Baseline and week 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Apolipoprotein B100 at Week 12	Baseline and week 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Full analysis set	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Total Cholesterol at Week 12	Baseline and week 12	Full analysis set	percent change	LEAST_SQUARES_MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group92

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Placebo Q2W	4.94	Standard Error 3.48	percent change
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Placebo QM	0.99	Standard Error 3.31	percent change
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Evolocumab Q2W	-65.35	Standard Error 3.09	percent change
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Evolocumab QM	-69.05	Standard Error 2.96	percent change
Percent Change From Baseline in LDL-C at Week 12	Placebo Q2W	7.10	Standard Error 3.66	percent change
Percent Change From Baseline in LDL-C at Week 12	Placebo QM	2.63	Standard Error 3.41	percent change
Percent Change From Baseline in LDL-C at Week 12	Evolocumab Q2W	-64.66	Standard Error 3.20	percent change
Percent Change From Baseline in LDL-C at Week 12	Evolocumab QM	-62.30	Standard Error 3.02	percent change
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Placebo Q2W	-2.1	Standard Error 4.1	mg/dL
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Placebo QM	-8.8	Standard Error 4.0	mg/dL

1 to 10 of 92Source ClinicalTrials.gov

See all 92 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Q2W	166
Overall Study	STARTED	Placebo QM	161
Overall Study	STARTED	Evolocumab Q2W	327
Overall Study	STARTED	Evolocumab QM	332
Overall Study	Received Study Drug	Placebo Q2W	164
Overall Study	Received Study Drug	Placebo QM	160
Overall Study	Received Study Drug	Evolocumab Q2W	325
Overall Study	Received Study Drug	Evolocumab QM	332
Overall Study	COMPLETED	Placebo Q2W	159
Overall Study	COMPLETED	Placebo QM	160

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events188

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
other	Nasopharyngitis	Infections and infestations	Placebo Q2W	6	164
other	Nasopharyngitis	Infections and infestations	Placebo QM	6	160
other	Nasopharyngitis	Infections and infestations	Evolocumab Q2W	9	325
other	Nasopharyngitis	Infections and infestations	Evolocumab QM	11	332
other	Upper respiratory tract infection	Infections and infestations	Placebo Q2W	6	164
other	Upper respiratory tract infection	Infections and infestations	Placebo QM	5	160
other	Upper respiratory tract infection	Infections and infestations	Evolocumab Q2W	9	325
other	Upper respiratory tract infection	Infections and infestations	Evolocumab QM	13	332
other	Diabetes mellitus	Metabolism and nutrition disorders	Placebo Q2W	2	164
other	Diabetes mellitus	Metabolism and nutrition disorders	Placebo QM	4	160

1 to 10 of 188Source ClinicalTrials.gov

See all 188 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Q2W	0	164
Total, all-cause mortality	Placebo QM	0	160
Total, all-cause mortality	Evolocumab Q2W	0	325
Total, all-cause mortality	Evolocumab QM	0	332
Total, other adverse events	Placebo Q2W	28	164
Total, other adverse events	Placebo QM	22	160
Total, other adverse events	Evolocumab Q2W	45	325
Total, other adverse events	Evolocumab QM	49	332
Total, serious adverse events	Placebo Q2W	6	164
Total, serious adverse events	Placebo QM	5	160

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30851062	DERIVED	PubMed
32318641	DERIVED	PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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