Study designed to evaluate the safety and efficacy of Evolocumab compared with placebo, in people with diabetes who have high cholesterol and who are already taking statin treatment

Phase 1

• Conditions: Hyperlipidemia or mixed dyslipidemia in Diabetic Subjects; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000723-14-FR
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-23
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1) Subject has provided written informed consent.
2) Male or female, = 18 to = 80 years of age at signing of informed consent.
3) Type 2 diabetes, defined as receiving pharmacologic treatment for type 2 diabetes for = 6 months prior to screening, with stable diabetes therapy prior to randomization to IP and not expected to change during the duration of study participation. Stable diabetes therapy is defined as no new agents added, no dose change of any oral antihyperglycemic drug within 2 months, and daily insulin dose not changed by > 25% and > 25 units within 1 month prior to randomization
4) Lipid-lowering therapy status (eg, not receiving any therapy or receiving any statin, ezetimibe, bile-acid sequestering resin, stanols, probucol, omega 3 fatty acids or niacin) must be unchanged for = 4 weeks prior to LDL-C screening.
5) Subjects receiving statin therapy at screening must have a fasting LDL-C at screening of = 100 mg/dL (2.6 mmol/L) as determined by central laboratory.
6) Subjects not receiving statin therapy at screening must have a fasting LDL-C at screening of = 130 mg/dL (3.4 mmol/L) as determined by central laboratory.
7) Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1) Receiving 20 mg atorvastatin QD monotherapy for approximately 16 weeks is medically contraindicated or inappropriate based on opinion of investigator.
2) NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%.
3) Uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that is not controlled by medications, in the past 6 months prior to randomization.
4) Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 6 months prior to randomization.
5) Planned cardiac surgery or revascularization within 6 months after randomization.
6) Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 10.0 % at screening and at lipid stabilization or not on stable pharmacologic therapy for type 2 diabetes. Stable therapy is defined as no new agents added, no dose change of any oral antihyperglycemic drug within 2 months, and daily insulin dose not changed by > 25% and > 25 units within 1 month prior to randomization.
7) Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
8) Subject is unwilling or unable to discontinue between start of lipid stabilization with 20 mg/day atorvastatin and end of study (week 12 for QM and week 14 for Q2W subjects) the following drugs or supplements: red yeast rice, niacin (> 200 mg/day), > 1000 mg/day omega-3 fatty acids (eg, Docosahexaenoic acid [DHA] and eicosapentaenoic acid [EPA], prescription and non-prescription combined), and all other prescription lipid-regulating drugs (eg, fibrates and derivatives, ezetimibe, bile-acid sequestering resin, stanols, or probucol) except study-provided atorvastatin.
9) Subject has taken a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to randomization, such as: anacetrapib, dalcetrapib or evacetrapib.
10) Treatment in the last 2 months prior to screening and lipid stabilization assessments with any of the following drugs: systemic cyclosporine, systemic steroids (eg, intravenous [IV], intramuscular [IM], or oral [PO] administration), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (eg, Accutane); (Note: vitamin A in a multivitamin preparation is permitted).
11) Hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening.
12) Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 at screening.
13) Persistent active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by central laboratory analysis at screening or lipid stabilization assessments.
14) Creatine kinase (CK) > 3 times the ULN at screening or lipid stabilization assessments.
15) Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction (except diabetes).
16) Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization.
17) Female subject who has either (1) not used (an) acceptable method(s) of birth control (see protocol) for at least 1 month prior to screening or (2) is not w

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified