Anti-Interleukin-1 in Diabetes Action

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A draw trial of the effect of Interleukin-1 Receptor Antagonist (anakinra, Kineret®) on the insulin production in patients with new onset Type 1 diabetes.

Kineret® is already being used in the treatment of patients suffering from rheumatoid arthritis and preclinical studies are now suggesting that it may also be useful for patients with Type 1 diabetes. The active substance in Kineret is interleukin-1 receptor antagonist, a blocker of an immune-signal molecule named interleukin-1.

The trial is a blinded randomised trial, in which the patient is allocated to receive the active drug (Kineret®) or placebo (saline). The hypothesis is that anti-IL-1 treatment as add-on therapy to conventional insulin therapy will preserve or enhance beta-cell function.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Collaborators: Juvenile Diabetes Research Foundation; Oeresund Diabetes Academy
• Treatments: Insulin; Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Type 1 diabetes diagnosed according to WHO 1999 criteria

• Positive GAD auto-antibodies

• Age 18-35 yrs at onset of diabetes

• Time from first symptoms of diabetes < 12 weeks

• Peak C-peptide more than or equal to 200 pM after a standardized mixed meal test (Boost) at a test carried out when the subject is metabolically stable, i.e. after resolution of any polyuria, polydypsia or ketoacidosis.

Exclusion Criteria:

• Severe liver or renal disease (creatinine > 100 μmol/L, ASAT/ALAT > 2* ULN, alkaline phosphatase > 2 * ULN)

• History of heart disease, signs of cardiac failure or abnormal ECG

• Present or previous malignancy

• Pregnancy or failure of fertile female to comply with contraceptional planning, or breast-feeding. (Safe contraceptive methods include birth control pills, IUD, and gestagen implants) . Plans of pregnancy within 2 years.

• Participation in other clinical intervention studies

• Anti-inflammatory therapy (except aspirin £ 100 mg/d)

• Active infections (CRP>30), history of recurrent infection or predisposition to infections

• Neutropenia: ANC < 1.5*109/L, or anaemia: Haemoglobin < 8.0 g/dL

• Immune-suppressive treatment or immune-deficiency

• Presence at diagnosis of late diabetic complications

• Concurrent vaccination with live vaccine. Known need for live vaccinations within 2 years.

• Use of Etanercept within 6 months before screening or during the double-blinded study period

• Hypersensitivity to E. coli-derived proteins, anakinra or any components of the product.