Phase
Condition
Diabetes Prevention
Diabetes Mellitus, Type 2
Metabolic Disorders
Treatment
Anakinra Prefilled Syringe
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Main inclusion criteria:
Age ≥ 18 years and ≤ 70 years at screening
Male or female of non-child-bearing potential (meaning for women: not currentlypregnant, post-menopausal female or using condoms and either intrauterine devices or 3-monthly contraceptive injection or birth-control pill.)
Healthy subjects:
No apparent disease requiring medication
BMI < 25 kg/ m2
C-reactive protein ≤ 2 mg/L
Obese diabetic type 2 subjects:
Type 2 diabetes
HbA1c 7.0 -10.0%
BMI ≥ 30.0 kg/m2
C-reactive protein ≥ 2 mg/L
Exclusion
Exclusion criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation
Aversion or allergy to paracetamol or any component of the meal.
Known history of allergy or hypersensitivity to any component of the investigationalproduct formulations
Concomitant treatment with GLP-1 agonists, DPP-4 inhibitors, insulin or insulinderivative
Change in diabetes medication within the last 30 days
Any biologic drugs targeting the immune system
Fever, or other signs of infection requiring antibiotics within 3 weeks prior toscreening, history of recurrent infection, immunodeficiency, known HIV ortuberculosis infection, active foot ulcer
Participation in another study with investigational drug within 30 days prior toScreening and during the present study
eGFR < 30 mL/min/1.73m2 per MDRD formula or kidney transplant (regardless of renalfunction)
Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B andhepatitis C, or confirmed ALAT/ASAT levels > 3 times ULN or total bilirubin > 2times ULN),
Haemoglobin <10.0 g/dL, white blood cell <3.0 x 103/mm3, platelet count <125 x 103/mm3
Atrial fibrillation and/or a pacemaker
Study Design
Study Description
Connect with a study center
University Hospital Basel
Basel, Basel BS 4031
SwitzerlandSite Not Available
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