NCT05854251

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperinsulinemia
• PreDiabetes

Interventions

Type	Name	Description
DRUG	Anakinra	Subjects receive an s.c. injection of 100 mg Anakinra on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal
DRUG	Placebo	0.67 ml of s.c. injection of saline will be taken on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2023-05-11
• Last updated: 2025-01-29

Locations

1 site across 1 country: Switzerland