IL-1-Rezeptor-Antagonist während der cephalischen Phase der Insulinsekretion bei Gesundheit und Typ-2-Diabetes - Die Cephalira-Studie

Drug: Anakinra Prefilled Syringe

Gender: All
Maximum age: 70 Years
Minimum age: 18 Years

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 currently
pregnant, 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 criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

- Mental incapacity, unwillingness or language barriers precluding adequate
understanding or cooperation

- Aversion or allergy to paracetamol or any component of the meal.

- Known history of allergy or hypersensitivity to any component of the investigational
product formulations

- Concomitant treatment with GLP-1 agonists, DPP-4 inhibitors, insulin or insulin
derivative

- 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 to
screening, history of recurrent infection, immunodeficiency, known HIV or tuberculosis
infection, active foot ulcer

- Participation in another study with investigational drug within 30 days prior to
Screening and during the present study

- eGFR < 30 mL/min/1.73m2 per MDRD formula or kidney transplant (regardless of renal
function)

- Known active or recurrent hepatic disorder (including cirrhosis, hepatitis B and
hepatitis C, or confirmed ALAT/ASAT levels > 3 times ULN or total bilirubin > 2 times
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