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

Conditions

• Diabetes, Hyperlipidemia, Mixed Dyslipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — BIOLOGICAL
  Administered by subcutaneous injection
• Atorvastatin — DRUG
  Administered orally once a day
• Placebo — OTHER
  Placebo to evolocumab administered by subcutaneous injection

Study Details

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.

Key Dates

Start date

Apr 14, 2016

Status verified

Jan 2019

Primary completion

Dec 6, 2017

Completion

Dec 6, 2017

Study Design

Enrollment

986 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Atorvastatin (Q2W)
  Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
• Active Comparator: Atorvastatin (QM)
  Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
• Experimental: Evolocumab Q2W + 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.
• Experimental: Evolocumab QM + 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 Measure

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]

Locations (11)

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