The Effect of Anakinra on Insulin Secretion

Radboud University Medical Center

Status

Unknown

Conditions

Impaired Insulin Secretion

Diabetes Mellitus Type 2

Glucose Intolerance

Treatments

Drug: Anakinra

Study type

Interventional

Funder types

Other

Identifiers

NCT01285232

Anakinra1

Details and patient eligibility

About

Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.

Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.

Enrollment

16 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
BMI >25 kg/m2
Age 40-70 years

Exclusion criteria

Known diabetes mellitus
Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
Signs of current infection (fever, C-reactive protein >30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
A history of recurrent infections
Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
Renal disease defined as MDRD < 60 ml/min/1.73m2
Neutropenia < 2x 109/L
Inability to understand the nature and extent of the trial and the procedures required.
Any medical condition that might interfere with the current study protocol
Participation in a drug trial within 60 days prior to the first dose