Effects of Evolocumab on lipid metabolism in type 2 diabetes

Phase 1

• Conditions: type 2 diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-001176-30-FI
• Lead Sponsor: Clinical Research Institute, HUCH Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Male or female (non-fertile or using a medically approved birth control method)
overweight/obese subjects with T2D treated with lifestyle counselling and a stable
metformin dose for at least three months
- age 18–77 yrs.
- BMI 25–40 kg/m2
- triglycerides between 1.5–4.5 mmol/L and LDL cholesterol >1.8 but =4.0 mmol/L (on
Atorvastatin 20 mg/day)
- HbA1c: =9%.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Type 1 diabetes
- apoE2/2 phenotype
- ALT/AST > 3×ULN
- CK>3×UNL
- GFR <60 ml/min
- clinically significant TSH outside the normal range
- BMI >40 kg/m2
- HbA1C > 9.0 %
- fasting TG > 4.5 mmol/l
- total chol > 7.0 mmol/l
- positive urine or serum pregnancy test
- untreated or inadequately treated hypertension defined as blood pressure >160 mmHg
systolic and/or >105 mmHg diastolic, use of thiazide diuretics at a dose of =25 mg/day
- subject not on a stable dose of atorvastatin (20 mg/ day before randomization)
- lipid-lowering drugs other than statins within 3 months
- any other diabetes medication except diet + metformin
- history/diagnosis of diabetes nephropathy / retinopathy
- smoking
- weekly alcohol use over 24 doses for men and 16 for women
- history of MI, ACS or coronary revascularization (PCI or CABG) within the last 6 mos.
- NYHA class III/IV congestive heart failure persisting despite treatment
- history of hemorrhagic stroke
- hypersensitivity to any of the excipients found in the drug product
- use of estrogen therapy
- current use of antithrombotic or anticoagulant therapy
- known bleeding tendency that would be an contraindication to heparin test
- history of cancer within the past 5 years (except for adequately treated basal cell skin
cancer, squamous cell skin cancer or in situ cervical cancer)
- women of childbearing potential not protected by effective birth control method and/or
not willing to be tested for pregnancy
- patient considered by the investigator or any sub-investigator as inappropriate for this
study for any reason

Study & Design

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