Phase 3
Completed N=424
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
Hypercholesterolemia · Mixed Dyslipidemia · Type 2 Diabetes
Source: ClinicalTrials.gov NCT02739984 ↗
Enrolled (actual)
424
Serious AEs
3.8%
Results posted
Aug 2018
Primary outcomePrimary: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 — -0.84; -64.98 percent change — p=<0.0001
◆ Published Evidence
Established
71citations · ~10 / year
Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study.
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.
Linked Publications (2)
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Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study.
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Quantification of LDL-Cholesterol Corrected for Molar Concentration of Lipoprotein(a).
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 |
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
Data sourced from ClinicalTrials.gov (NCT02739984) and the linked publication. 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. Informational only — not medical advice.