ArticleEClinicalMedicine2022
A randomised, double-blind, placebo-controlled, multicentre clinical trial of AZD1656 in diabetic patients hospitalised with COVID-19: The ARCADIA Trial - implications for therapeutic immune modulation.
Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04516759 (A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Safety profile of glucokinase activator AZD1656: systematic review and meta-analysis of 23 randomised trials in diabetic and healthy volunteers with relevance to immunomodulatory therapy.Inflammopharmacology · 2025Pooled it
- Targeting immunometabolic pathways with AZD1656 alleviates inflammation and metabolic dysfunction in type 2 diabetic cardiomyopathy.Nature cardiovascular research · 2026Article
- Combined Adaptive Immune Mechanisms Mediate Cardiac Injury After COVID-19 Vaccination.Circulation · 2025Article
- Evaluating the Overall Safety of Glucokinase Activators in Patients with Type 2 Diabetes Mellitus.Diabetes, metabolic syndrome and obesity : targets and therapy · 2024Review
- Glucokinase activator improves glucose tolerance and induces hepatic lipid accumulation in mice with diet-induced obesity.Liver research (Beijing, China) · 2023Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
Background: A potential immunotherapeutic role for AZD1656 (a glucokinase activator) in the treatment of COVID-19 was hypothesized. The ARCADIA trial investigated the safety and efficacy of AZD1656 in diabetic patients admitted to hospital with COVID-19. Methods: The ARCADIA trial was a Phase II randomised, double-blind, placebo-controlled clinical trial. Adult diabetic patients, admitted with COVID-19, were recruited at 28 hospitals in the UK, Romania and Czech Republic and randomly assigned (1:1) to receive AZD1656 tablets (100mg twice a day), or matched placebo, for up to 21 days, in addition to usual care. All involved were masked to treatment allocation. The primary endpoint was clinical improvement measured at Day 14. The Full Analysis Set (FAS) included all patients who received at least one dose of assigned treatment. ARCADIA is complete and registered with ClinicalTrials.gov (NCT04516759). Findings: Between 29 September 2020 to 16 April 2021, 170 patients were screened and 156 patients were randomised, three of whom did not commence treatment. Of the remaining 153, 80 were assigned to AZD1656 and 73 were assigned to placebo and included in the Full Analysis Set (FAS). The primary analysis showed no statistically significant difference between groups (AZD1656: 76·3%; Placebo: 69·9%, Interpretation: Although the trial did not achieve its primary endpoint, AZD1656 was associated with a decrease in deaths and a reduction in the duration of hospitalisation, as compared to Placebo. Immunophenotyping and immunochemistry indicated an immunomodulatory effect of AZD1656. The trial suggests a beneficial therapeutic effect of AZD1656 and identifies a new therapeutic concept: small molecule activation of endogenous homeostatic immune cells which themselves become the therapeutic agent within the body. Phase 2 trials of this size carry the risk of false positive results and confirmation of these results in a larger clinical trial is now required. Funding: UK Research and Innovation (UKRI) 'Innovate UK' programme and Excalibur Medicines Ltd.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.