NCT05854251 (Hyper-PreDIL) is a Phase 2 clinical trial of Anakinra in Hyperinsulinemia, sponsored by University Hospital, Basel, Switzerland.

Who is sponsoring NCT05854251?

NCT05854251 is sponsored by University Hospital, Basel, Switzerland.

What drugs are being tested in NCT05854251?

Interventions in NCT05854251: Anakinra, Placebo.

What condition does NCT05854251 study?

NCT05854251 studies Hyperinsulinemia, PreDiabetes.

Is NCT05854251 still recruiting?

NCT05854251 is currently completed. Last updated 29 January 2025.

Last reviewed 2025-01-29 · How we verify

NCT05854251: Hyper-PreDIL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

Completed Phase 2 Last updated 29 January 2025

What this trial tests

Phase 2 trial testing Anakinra in Hyperinsulinemia in 20 participants. Completed in 17 May 2024.

Timeline

15 June 2023

Primary endpoint
17 May 2024

17 May 2024

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	15 June 2023
Primary completion	17 May 2024
Estimated completion	17 May 2024
Sites	1 location across Switzerland

Drugs / interventions tested

Anakinra (ANAKINRA) — full drug profile →
Placebo

Conditions studied

Hyperinsulinemia — all drugs for Hyperinsulinemia →
PreDiabetes — all drugs for PreDiabetes →

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Hyperinsulinemia or PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Acute interleukin-1β antagonism decreases systemic inflammation, increases GLP-1 release, and modulates insulin secretion in individuals with prediabetes.
Fischer JS, Hepprich M, Cattaneo M, Seeger L, et al · · 2026 · PMID 41778408 · DOI 10.1152/ajpendo.00527.2025
Immune Cell-Based Clustering Reveals Clinically Distinct Endotypes in Type 2 Diabetes
Venteclef N, Vuong B, delepine c, ratter-rieck j, et al · · 2025 · DOI 10.21203/rs.3.rs-7752906/v1

Verify or expand the search:

Other trials of Anakinra

Trials testing the same drug.

NCT06381661 — Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Tra · Phase 2 · not yet recruiting
NCT07281027 — COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" · Phase 3 · not yet recruiting
NCT07191444 — A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease · recruiting
NCT06666335 — A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF · Phase 4 · not yet recruiting
NCT06697431 — Non Inferiority KawasakI Trial With Anakinra · Phase 4 · not yet recruiting

Other recruiting trials for Hyperinsulinemia

Currently open trials in the same condition.

NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
NCT03374215 — Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks · recruiting

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

NCT07444788 — Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants · Phase 1 · recruiting
NCT07494214 — Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants · Phase 1 · recruiting
NCT07419048 — Artificial Intelligence or Human Hand? Evaluating Inferior Vena Cava Imaging for Hydration Status · recruiting
NCT06978777 — Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity · NA · recruiting
NCT07273630 — Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05854251 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Basel, Switzerland
Last refreshed: 29 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05854251.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing