ECE2022 Oral Communications Oral Communications 1: Diabetes, Obesity, Metabolism and Nutrition 1 (5 abstracts)
Canakinumabin patients with COVID-19 and type 2 diabetes (CanCovDia) – a multicentric, randomised, double-blind, placebo-controlled phase 3 trial
Matthias Hepprich 1 , Jonathan Mudry 1 , Claudia Gregoriano 2 , Francois R Jornayvaz 3 , Sebastian Carballo 4 , Anne Wojtusciszyn 5 , Pierre-Alexandre Bart 6 , Jean-Daniel Chiche 7 , Stefan Fischli 8 , Thomas Baumgartner 9 , Claudia Cavelti-Weder 9 , Felix Beuschlein 9 , Dominque L Braun 10 , Huldrych F Günthard 10 , Emily West 10 , Anna Conen 2 , Egon Isenring 2 , Gabriela Bucklar 1 , Yoann Aubry 1 , Ludovic Dey 1 , Beat Müller 2 , Philipp Schütz 2 , Marco Cattaneo 11 , Patrick Hunziker 12 & Marc Y Donath 1
1University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism, Switzerland; 2Kantonsspital Aarau, Medical University Department of Medicine, Aarau, Switzerland; 3Geneva University Hospital, Division of Endocrinology, Diabetes, Nutrition and Therapeutic Patient Education, Genève, Switzerland; 4Geneva University Hospital, Division of General Internal Medicine, Department of Medicine, Genève, Switzerland; 5Centre Hospitalier Universitaire Vaudois, Service d’Endocrinologie Diabète et Métabolisme, Lausanne, Switzerland; 6Centre Hospitalier Universitaire Vaudois, Service of Internal Medicine, Lausanne, Switzerland; 7Department of Intensive Care Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; 8Luzerner Kantonsspital, Department of Endocrinology, Luzern, Switzerland; 9Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich, Zürich, Switzerland; 10University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology, Zürich, Switzerland; 11University of Basel, Department of Clinical Research, Basel, Switzerland; 12University Hospital Basel, University of Basel, Intensive Care Unit, Basel, Switzerland
Background: Patients with type 2 diabetes and overweight have a chronic activation of the innate immune system possibly explaining the increased risk of a hyperinflammatory response and severe COVID-19. We aimed to test whether blockade of interleukin-1β(IL-1β) using canakinumab improves clinical outcome.
Methods: CanCovDia was a multicenter, randomised, double-blind, placebo-controlled trial to assess the efficacy of canakinumab plus standard-of-care compared with placebo plus standard-of-care in patients with type 2 diabetes and a BMI > 25 kg/m2 hospitalised with SARS-CoV2 infection. Patients were randomly assigned 1:1 to a single dose of canakinumab (body weight-adapted dose of 450-750 mg) or placebo intravenously. Canakinumab and placebo were compared on the basis of an unmatched win-ratio approach consisting of length of survival, ventilation, ICU stay and hospitalization. This study is registered with ClinicalTrials.gov, NCT04510493.
Findings: Between October 23, 2020, and May 12, 2021, 116 patients were randomly assigned with 58 in each group. The win-ratio analysis between canakinumab vs placebo was 1·08 (95% CI 0·69-1·69; P=0·72). After four weeks, in the canakinumab group 4 people died (7·0%), 12 were hospitalized for more than 3 weeks (23·5%), and 11 were on ICU (20·0%), vs 7 (12·3%), 16 (28·3%) and 11 patients (21·6%) respectively. Median ventilation time at 29 days was 10 days [IQR 6.0, 16.5] in the canakinumab group and 16 days [IQR 14.0, 23.0] in the placebo group. Glycated haemoglobin A1c (HbA1c) in the canakinumab group after four weeks was 7·40 [6·65, 8·30] vs 7·50 in the placebo group ([6·68, 8·33] P=0·955) despite a lower number of antidiabetics administered in patients treated with canakinumab vs placebo (OR 0·47 [95% CI 0·23-0·95] P=0·03). Median ratio to baseline of endogenous Insulin ( pmol/l) at four weeks was 0.94 [0.59, 1.66] in the canakinumab group vs placebo 0.64 [0.29, 1.44] (OR 2.21 [1.09, 4.48] (P=0.029). Serious adverse events were reported in 13 (11·4%) patients in each group treated with canakinumab and placebo, respectively.
Interpretation: In patients with type 2 diabetes who were hospitalised with COVID-19, treatment with canakinumab in addition to standard-of-care did not result in a significant improvement of the primary composite outcome despite a numerical benefit in survival, ICU and ventilation time. Patients treated with canakinumab required significant less antidiabetic drugs to achieve similar glycaemic control, possibly due to increased insulin production.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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