Phase 3
Completed N=986
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT02662569 ↗
Enrolled (actual)
986
Serious AEs
4.4%
Results posted
Jan 2019
Primary outcomePrimary: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 — 4.94; 0.99; -65.35; -69.05 percent change — p=<0.0001
◆ Published Evidence
Established
32citations · ~5 / year
Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial.
Summary
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.
Linked Publications (2)
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Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial.
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Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
4.94; 0.99; -65.35; -69.05 | <0.0001 sig |
| PRIMARY Percent Change From Baseline in LDL-C at Week 12 |
7.10; 2.63; -64.66; -62.30 | <0.0001 sig |
| SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
-2.1; -8.8; -64.6; -71.9 | <0.0001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 12 |
-0.3; -7.3; -63.9; -66.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 |
4.33; 0.33; -56.57; -59.08 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 |
5.87; 1.30; -55.76; -52.92 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12 |
1.97; -1.52; -54.96; -56.37 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B100 at Week 12 |
3.17; -0.26; -53.90; -49.68 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 |
2.89; -0.25; -38.64; -39.74 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 12 |
4.40; 0.67; -37.82; -35.22 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 |
3.03; -2.03; -41.06; -45.70 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 |
3.22; -1.22; -40.72; -41.78 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 |
2.60; -1.02; -55.60; -57.75 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12 |
3.23; -0.10; -54.98; -51.80 | <0.0001 sig |
| SECONDARY Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) |
21.7; 19.4; 90.1; 91.3 | <0.0001 sig |
| SECONDARY Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12 |
20.9; 21.3; 88.2; 90.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 |
16.89; 8.48; -38.63; -42.29 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 |
26.53; 7.47; -35.93; -37.85 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 |
11.54; 8.48; -6.48; -7.15 | 0.0002 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 12 |
10.50; 8.07; -5.91; -4.24 | 0.0002 sig |
| SECONDARY Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 |
1.25; 5.88; 7.59; 13.75 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 |
2.57; 6.04; 8.45; 14.18 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 |
9.63; 7.92; -17.55; -16.09 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy
- Lipid-lowering therapy must be unchanged for at least 4 weeks or more
- Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL
- Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL
Exclusion criteria
- New York Heart Association (NYHA) class III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes or poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism.
Data sourced from ClinicalTrials.gov (NCT02662569) 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.