Study is to evaluate evolocumab in people with type 2 diabetes mellitus with high cholesterol (hypercholesterolemia or mixed dyslipidemia).

Phase 1

• Conditions: Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia; MedDRA version: 20.1Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-004711-21-IT
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

-Subject has provided written informed consent

-Male or female = 18 years of age at signing of informed consent

-Type 2 diabetes mellitus:
•with hemoglobin A1c (HbA1c) < 10%
•receiving pharmacologic treatment for diabetes mellitus for = 6 months prior to screening
•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, and no dose change of any antihyperglycemic drug within 2 months prior to randomization and daily insulin dose not changed by > 25% and > 25 units within 1 month prior to randomization

-Subject must be on maximally tolerated dose of statin of at least moderate intensity at signing of the informed consent (see Appendix D) and is expected to remain on stable statin intensity for the duration of study in the opinion of the investigator:
•subjects without known clinical CVD must be on at least moderate-intensity statin prior to randomization
• subjects with known clinical CVD must be on high intensity statin (or moderate intensity if certified by principal investigator to be highest tolerated dose) prior to randomization). Clinical CVD is defined as a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin.

-Subjects without known clinical CVD must have a fasting LDL-C during lipid stabilization of = 100 mg/dL (2.6 mmol/L) or non-HDL-C = 130 mg/dL (3.4 mmol/L) as determined by the central laboratory

-Subjects with known clinical CVD must have a fasting LDL-C during lipid stabilization of = 70 mg/dL (1.8 mmol/L) or Non-HDL-C = 100 mg/dL (2.6 mmol/L) as determined by the central laboratory

-Fasting triglycerides = 600 mg/dL (6.8 mmol/L) by central laboratory prior to randomization

-Subject tolerates screening placebo injection

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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization

-Uncontrolled hypertension defined as sitting systolic blood pressure (BP) > 180 mmHg or diastolic BP > 110 mmHg

-Subject has taken a cholesterylester transfer protein inhibitor in the last 12 months prior to randomization, such as: anacetrapib, dalcetrapib, or evacetrapib

-Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate < 20 mL/min/1.73 m2 during screening

-Persistent active liver disease or hepatic dysfunction, defined as Child-Pugh score of C

-Female subject of childbearing potential not willing to use an acceptable method(s) of effective birth control during the screening/lipid stabilization period, during treatment with IP and for an additional 15 weeks after the end of treatment with IP.

Female subjects of non-childbearing potential are not required to use contraception during the study and include those who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or who are postmenopausal. Postmenopausal is defined as 12 months of spontaneous and continuous amenorrhea in a female = 55 years old; or age < 55 years but no spontaneous menses for at least 2 years; or age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of postmenopausal range for the laboratory involved.

Acceptable methods of effective birth control include:
•true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception),
•vasectomized partner (provided that partner is the sole sexual partner of the female participant who is of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success),
•bilateral tubal ligation/occlusion, use of hormonal birth control methods (oral, intravaginal, [eg, vaginal ring], transdermal, injectable, or implantable),
• intrauterine devices,
•intrauterine hormonal releasing system, or
•2 barrier methods (each partner must use one barrier method) and the female partner must use if available spermicide in addition to a barrier – males must use a condom; females must choose either a diaphragm, OR cervical cap, OR contraceptive sponge. (Note: If spermicide is not commercially available in the country or region, the two barrier method without spermicide iswould then be considered acceptable.).
Note: Additional medications given during the study may alter the contraceptive requirements. These additional medications may require an increase in the number of contraceptive methods, the change in type of contraceptive methods and/or length of time that contraception is to be utilized and/or length of time breastfeeding is to be avoided. The investigator is to discuss these contraceptive changes with the study subject.

- Female subject is pregnant or breast feeding, or planning to become pregnant or planning to breastfeed during the screeni

Study & Design

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