Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β (Hyper-PreDIL)

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Hyperinsulinemia; PreDiabetes

Treatments: Drug: Placebo; Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT05854251

2023-00497 kt23Donath2;

Details and patient eligibility

About

The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®).

The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with prediabetes defined by HbA1c 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l or plasma glucose 2 h following 75g glucose ingestion of 7.8-11.0 mmol/l.
• BMI ≥ 28 kg/m2
• Age ≥ 18 years
• C-reactive protein ≥ 2 mg/dl
• For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study

Exclusion criteria

• Upper gastrointestinal surgery
• Diagnosis of any type of diabetes mellitus
• Signs of current infection
• Use of any glucose lowering medication within the last three months
• Use of investigational drug up to one week prior to start of treatment phase.
• Anti-inflammatory medication, including systemic glucocorticoid therapy.
• Neutropenia (leukocyte count < 1.5 × 109/L or absolute neutrophil count (ANC) < 0.5 × 109/L)
• Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females)
• Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN)
• Uncontrolled disease
• Currently pregnant or breastfeeding
• No subjects meeting the criteria for vulnerability. Participation in another study with investigational drug within the 30 days preceding and during the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Experimental Intervention

Experimental group

Description:

Patients receive investigational product

Treatment:

Drug: Anakinra

Control Intervention

Placebo Comparator group

Description:

Patients receive placebo

Treatment:

Drug: Placebo