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

Phase 3

Completed

• Conditions: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
• Interventions: Drug: Atorvastatin; Biological: Evolocumab; Other: Placebo

• Registration Number: NCT02662569
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Study Start: 2016-04-14
• Primary Completion: 2017-12-06
• Study Completion: 2017-12-06
• Results First Submitted: 2018-11-30
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Results First Posted: 2019-01-11
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 986

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin (Q2W)	Atorvastatin	Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Atorvastatin (Q2W)	Placebo	Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Atorvastatin (QM)	Atorvastatin	Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Atorvastatin (QM)	Placebo	Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab Q2W + Atorvastatin	Evolocumab	Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab QM + Atorvastatin	Evolocumab	Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab Q2W + Atorvastatin	Atorvastatin	Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
Evolocumab QM + Atorvastatin	Atorvastatin	Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12	Baseline and week 12

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)	Weeks 10 and 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12	Baseline and week 12
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12	Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12	Baseline and week 12
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B100 at Week 12	Baseline and week 12
Percent Change From Baseline in Total Cholesterol at Week 12	Baseline and week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12	Baseline and week 12
Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12	Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12	Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12	Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12	Baseline and week 12

Trial Locations

Locations (1)

Research Site; 🇹🇷 Kocaeli, Turkey