Phase 3 N=424 Randomized Triple-blind Treatment

Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

Hypercholesterolemia · Mixed Dyslipidemia · Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02739984 ↗

Enrolled (actual)

424

Serious AEs

3.8%

Results posted

Aug 2018

Primary outcome: Primary: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 — -0.84; -64.98 percent change — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Evolocumab (Biological); Placebo to Evolocumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	-0.84; -64.98	<0.0001 sig
PRIMARY Percent Change From Baseline in LDL-C at Week 12	-1.14; -54.28	<0.0001 sig
SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	-8.3; -75.5	<0.0001 sig
SECONDARY Change From Baseline in LDL-C at Week 12	-8.6; -64.4	<0.0001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	-0.05; -56.62	<0.0001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12	-0.60; -46.89	<0.0001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12	2.31; -50.17	<0.0001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12	1.78; -40.34	<0.0001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12	-1.13; -42.19	<0.0001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol at Week 12	-1.23; -34.97	<0.0001 sig
SECONDARY Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)	14.8; 92.7	<0.0001 sig
SECONDARY Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)	15.4; 84.5	<0.0001 sig
SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12	0.7; 84.2	<0.0001 sig
SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12	0.8; 65.5	<0.0001 sig
SECONDARY Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12	9.63; -30.87	<0.0001 sig
SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12	7.38; -25.18	<0.0001 sig
SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12	6.61; -12.64	<0.0001 sig
SECONDARY Percent Change From Baseline in Triglycerides at Week 12	4.81; -8.90	<0.0001 sig
SECONDARY Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12	-2.57; 7.23	<0.0001 sig
SECONDARY Percent Change From Baseline in HDL-C at Week 12	-1.41; 5.96	<0.0001 sig
SECONDARY Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12	3.42; -13.64	<0.0001 sig
SECONDARY Percent Change From Baseline in VLDL-C at Week 12	3.02; -10.31	<0.0001 sig

Summary

The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

Eligibility Criteria

Inclusion Criteria

Male or female ≥ 18 years
Type 2 Diabetes Mellitus
Hemoglobin A1c < 10%
Stable diabetes therapy
Must be on maximally tolerated dose of statin of at least moderate Intensity
Fasting triglycerides ≤ 600 mg/dL
Not at LDL-C or Non-HDL-C goal.

Exclusion Criteria

Moderate to severe renal dysfunction
Uncontrolled hypertension
Persistent active liver disease or hepatic dysfunction
Has taken a cholesterylester transfer protein inhibitor in the last 12 months,
Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02739984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.