Blood sugar control and low blood sugar risk with once-weekly insulin icodec versus daily basal insulin in type 2 diabetes, considering use of common diabetes pills
21.3% of participants in ONWARDS 1-5 were treated with a GLP-1 receptor agonist.
36.9% of participants were treated with a sodium-glucose co-transporter-2 inhibitor.
Baseline characteristics were similar across treatment groups, regardless of GLP-1RA or SGLT2i use.
No statistically significant treatment interactions were observed for changes in glycated hemoglobin or body weight based on GLP-1RA or SGLT2i use.
Weekly basal insulin doses did not show significant differences related to GLP-1RA or SGLT2i use, except in one trial.
Rates of clinically significant or severe were generally low, averaging less than one episode per patient-year of exposure.
Simplified
AIMS: To assess the treatment effects of once-weekly insulin icodec (icodec) versus once-daily basal insulin comparators in individuals with type 2 diabetes (T2D) according to baseline glucagon-like peptide-1 receptor agonist (GLP-1RA) and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use.
MATERIALS AND METHODS: This post hoc analysis of the randomized ONWARDS 1-5 trials of individuals with T2D assessed treatment outcomes by trial according to baseline GLP-1RA and/or SGLT2i use.
RESULTS: At screening, 21.3% (801/3765) and 36.9% (1388/3765) of participants in ONWARDS 1-5 were treated with a GLP-1RA or an SGLT2i, respectively. Baseline characteristics were broadly similar across treatment arms irrespective of GLP-1RA/SGLT2i use; GLP-1RA users had numerically higher body mass indices than non-users. Across trials, there were no statistically significant treatment interactions by GLP-1RA or SGLT2i subgroups with respect to: change in glycated haemoglobin () and body weight from baseline to end of treatment (except for body weight change by SGLT2i use in ONWARDS 5); weekly basal insulin dose during the last 2 weeks of treatment (except SGLT2i use in ONWARDS 5); and achievement of HbA1c less than 7% without clinically significant or severe . Irrespective of GLP-1RA/SGLT2i use, the rates of clinically significant or severe hypoglycaemia were less than one episode per patient-year of exposure across all trials except ONWARDS 4 (basal-bolus trial).
CONCLUSIONS: The efficacy and hypoglycaemia profile of icodec versus once-daily comparators was generally consistent across ONWARDS trials irrespective of background GLP-1RA and/or SGLT2i use.
Key numbers
801 of 3765
Participants treated with GLP-1RAs
Percentage of participants in ONWARDS 1-5 treated with GLP-1RAs at screening.
1388 of 3765
Participants treated with SGLT2is
Percentage of participants in ONWARDS 1-5 treated with SGLT2is at screening.
<1 episode/PYE
rate
Rate of clinically significant or severe across ONWARDS 1, 2, 3, and 5.
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Tina Vilsbøll has served on scientific advisory panels, been part of speaker's bureaus, served as a consultant to and/or received research support from Amgen, AstraZeneca, Boehringer Ingelheim, Carmot/Roche, Eli Lilly, Gilead, GSK, Mundipharma, Novo Nordisk, Sanofi, Sun Pharmaceuticals and Zealand Pharma. Ariel Fu and Stinne Byrholdt Søgaard are employees of Novo Nordisk and hold stock in Novo Nordisk. Monika Kellerer has received consulting fees from Abbott, Bayer AG, Boehringer Ingelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and honoraria for lectures, presentations, speakers' bureaus and educational events from Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim, Eli Lilly, MedLearning, MSD, Novartis, Novo Nordisk and SCIARC. Bharath Kumar is an employee of Novo Nordisk India Private Limited. Ronald Goldenberg has received research fees from Eli Lilly, Novo Nordisk and Sanofi (paid to their institution), as well as consultancy and lecture honoraria from Eli Lilly, Novo Nordisk and Sanofi.
