Overview

Effect of Anakinra on Insulin Sensitivity in Type 1 Diabetes Mellitus

Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test whether anakinra is able to reduce insulin resistance. This will be tested in overweighted type I diabetes mellitus patients, which have no residual beta-cell function. By using this patient group, all positive effects on glycemic control should be the consequence of improved insulin sensitivity.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University
Treatments:
Insulin
Insulin, Globin Zinc
Interleukin 1 Receptor Antagonist Protein
Criteria
Inclusion Criteria:

- Type 1 diabetes for more than 5 years

- Body mass index of > 25 kg/m2

- Insulin requirement > 0.5 U/kg bodyweight

- HbA1c>7.5%, stable glycemic control

Exclusion Criteria:

- Inability to give informed consent

- Presence of any medical condition that might interfere with the current study
protocol.

- Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and
corticosteroids)

- Anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs, 100 mg or
less of aspirin per day is allowed)

- Signs of current infection (fever, C-reactive protein (CRP) > 30 mmol/l, treatment
with antibiotics, previous or current diagnosis of tuberculosis.

- A history of recurrent infections

- Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is
required for fertile women)

- Liver disease (aspartate aminotransferase or alanine aminotransferase level of more
than three times the upper limit of normal range)

- Renal disease (creatinine > 130 µmol/l

- Neutropenia < 2 x 109/l