type 2 diabetes
Conditions
Interventions
Trade Name: Repatha
Product Name: Evolokumabi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: EVOLOCUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Clinical Research Institute, HUCH Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Type 1 diabetes - apoE2/2 phenotype - ALT/AST > 3×ULN - CK>3×UNL - GFR 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim is to clarify the postprandial dynamics of PCSK9 on the pathophysiology of postprandial hypertriglyceridemia in people with type 2 diabetes. The effect of 12 weeks treatment with Evolocumab 140 mg s.c. Q2W on postprandial lipid and lipoprotein metabolism will be assessed in patients with type 2 diabetes (n=12) in an one-arm unblinded clinical trial.;Secondary Objective: not applicable;Primary end point(s): ApoB48 production rate;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Chylomicron (Sf 400) TG IAUC and apoB48 IAUC during the standardized fat-rich mixed meal test b. VLDL1, VLDL2 and LDL production and fractional catabolic rates c. Visceral fat volume and liver fat content (%) determined by MRI;Timepoint(s) of evaluation of this end point: at the end of the study | — |
Countries
Finland
Contacts
Public ContactClinical Research Institute, HUCH
Clinical Research Institute, HUCH Ltd.
Outcome results
None listed