Liraglutide hospital discharge trial: A randomized controlled trial comparing the safety and efficacy of liraglutide versus insulin glargine for the management of patients with type 2 diabetes after hospital discharge

• Type of Material: Article
• Authors: Francisco Pasquel, Emory University; Maria A Urrutia, Emory University; Saumeth Cardona, Emory University; Karla WZ Coronado, Emory University; Bonnie Albury, Emory University; Mireya C Perez-Guzman, Emory University; Rodolfo Galindo, Emory University; Ajay Chaudhuri, State University of New York at Buffalo; Gianluca Iacobellis, University of Miami; Juan Palacios, University of Miami; Javier M Farias, Div Endocrinol Sanatorio Guemes; Patricia Gomez, Emory University; Isabel Anzola, Emory University; Priyathama Vellanki, Emory University; Maya Fayfman, Emory University; Georgia Davis, Emory University; Alexandra Migdal, Emory University; Limin Peng, Emory University; Guillermo Umpierrez, Emory University
• Language: English
• Date: 2021-03-31
• Publisher: WILEY
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2021 John Wiley & Sons Ltd
• Final Published Version (URL): http://dx.doi.org/10.1111/dom.14347
• Title of Journal or Parent Work: DIABETES OBESITY & METABOLISM
• Volume: 23
• Issue: 6
• Start Page: 1351
• End Page: 1360
• Grant/Funding Information: The study was an investigator-initiated study funded by Novo Nordisk. The funding source was not involved in the study design, data collection, interpretation, statistical analysis, manuscript preparation, or the decision to submit the manuscript for publication.; This work was an investigator-initiated grant, with unrestricted research support provided by Novo Nordisk to Emory University. The funding source had no input on the design of the study, interpretation of the results or manuscript preparation.
• Keywords: glargine; type 2 diabetes; CRITICALLY-ILL; inpatient hyperglycaemia; Science & Technology; GLP‐ hospital discharge; MORTALITY; HYPERGLYCEMIA; Endocrinology & Metabolism; hospital hyperglycaemia; algorithm; SITAGLIPTIN; Life Sciences & Biomedicine; THERAPY; OUTCOMES; GLUCOSE CONTROL; 1RA

Abstract

Aim: To compare a glucagon-like peptide-1 receptor agonist with basal insulin at hospital discharge in patients with uncontrolled type 2 diabetes in a randomized clinical trial. Methods: A total of 273 patients with glycated haemoglobin (HbA1c) 7%–10% (53–86 mol/mol) were randomized to liraglutide (n = 136) or insulin glargine (n = 137) at hospital discharge. The primary endpoint was difference in HbA1c at 12 and 26 weeks. Secondary endpoints included hypoglycaemia, changes in body weight, and achievement of HbA1c <7% (53 mmol/mol) without hypoglycaemia or weight gain. Results: The between-group difference in HbA1c at 12 weeks and 26 weeks was −0.28% (95% CI −0.64, 0.09), and at 26 weeks it was −0.55%, (95% CI −1.01, −0.09) in favour of liraglutide. Liraglutide treatment resulted in a lower frequency of hypoglycaemia <3.9 mmol/L (13% vs 23%; P = 0.04), but there was no difference in the rate of clinically significant hypoglycaemia <3.0 mmol/L. Compared to insulin glargine, liraglutide treatment was associated with greater weight loss at 26 weeks (−4.7 ± 7.7 kg vs −0.6 ± 11.5 kg; P < 0.001), and the proportion of patients with HbA1c <7% (53 mmol/mol) without hypoglycaemia was 48% versus 33% (P = 0.05) at 12 weeks and 45% versus 33% (P = 0.14) at 26 weeks in liraglutide versus insulin glargine. The proportion of patients with HbA1c <7% (53 mmol/mol) without hypoglycaemia and no weight gain was higher with liraglutide at 12 (41% vs 24%, P = 0.005) and 26 weeks (39% vs 22%; P = 0.014). The incidence of gastrointestinal adverse events was higher with liraglutide than with insulin glargine (P < 0.001). Conclusion: Compared to insulin glargine, treatment with liraglutide at hospital discharge resulted in better glycaemic control and greater weight loss, but increased gastrointestinal adverse events.