Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

Phase 2

Completed

• Conditions: Hyperinsulinemia; PreDiabetes
• Interventions: Drug: Placebo; Drug: Anakinra

• Registration Number: NCT05854251
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-11
• Study Start: 2023-06-15
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Intervention	Placebo	Patients receive placebo
Experimental Intervention	Anakinra	Patients receive investigational product

Primary Outcome Measures

Name	Time	Method
Change in insulin concentration following a standardized mixed-meal test	two time assessment at baseline and after 1-2 weeks	Changes in insulin concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
Change in glucose concentration following a standardized mixed-meal test	two time assessment at baseline and after 1-2 weeks	Changes in glucose concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
Change in c-peptide concentration following a standardized mixed-meal test	two time assessment at baseline and after 1-2 weeks	Changes in c-peptide concentration (nmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test	two time assessment at baseline and after 1-2 weeks	Changes in insulinogenic index (IGI) (I30 - I0)/(G30 - G0) under anakinra compared to placebo.; Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland