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