Diabetologie und Stoffwechsel 2023; 18(S 01): S63
DOI: 10.1055/s-0043-1767990
Abstracts | DK 2023
Poster
Postersitzung 14

Once-Weekly Insulin Icodec vs Once-Daily Insulin Glargine U100 in Combination with Bolus Insulin in Individuals with Type 2 Diabetes on Basal-Bolus Regimens (ONWARDS 4)

Birgit Nicola
1   Novo Nordisk Pharma GmbH, Medical Affairs, Mainz, Germany
,
Chantal Mathieu
2   University of Leuven, -, Leuven, Belgium
,
Björg Ásbjörnsdóttir
3   Novo Nordisk A/S, -, Søborg, Denmark
,
Harpreet Singh Bajaj
4   LMC Diabetes and Endocrinology Brampton, ON, Canada and Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto, ON, Canada, -, Brampton, Canada
,
Wendy Lane
5   Mountain Diabetes and Endocrine Center, -, Asheville, United States
,
Sreenivasa Murthy
6   Lifecare Hospital and Research Centre, -, Bangalore, India
,
Karolina Stachlewska
3   Novo Nordisk A/S, -, Søborg, Denmark
,
Julio Rosenstock
7   Dallas Diabetes and Endocrine Center, -, Dallas, United States
› Institutsangaben
 

Objective ONWARDS 4 was a 26-week, randomised, treat-to-target, phase 3 trial, designed to assess efficacy and safety of once-weekly insulin icodec (icodec) vs once-daily insulin glargine U100 (glargine) in a basal-bolus insulin regimen in type 2 diabetes(T2D).

Method Adults (n=582) with T2D (HbA1c 7.0–10.0%) on a basal-bolus regimen were randomised 1:1 to icodec or glargine, both in combination with multiple daily injections of insulin aspart. Primary endpoint was change in HbA1c from baseline to week 26(non-inferiority margin 0.3%).

Result At week 26, from a mean baseline of 8.3%, estimated HbA1c reductions were -1.16% (icodec) and -1.18% (glargine), confirming non-inferiority for icodec vs glargine (estimated treatment difference [ETD]: 0.02% [95% CI, -0.11 to 0.15]; p<0.0001). Overall rates of combined level 2 or level 3 hypoglycaemia were comparable between treatments (5.64 [icodec] and 5.62 [glargine] per patient year of exposure; estimated rate ratio: 0.99 [95% CI, 0.73 to 1.33]; p=0.929). Mean total weekly basal component of the total insulin dose from week 24–26 was significantly higher in the icodec arm vs the glargine arm (305 U/week vs 279 U/week; p=0.0286), while the mean total weekly bolus insulin component was significantly lower (197 U/week vs 255 U/week; p<0.0001). Estimated mean body weight change was 2.73 kg(icodec) and 2.16 kg (glargine) (ETD: 0.57 kg [95% CI, -0.39 to 1.54]; p=0.2444).

Conclusion Once-weekly icodec demonstrated comparable improvements in glycaemic control with fewer basal insulin injections, with a comparable hypoglycaemia profile vs once-daily glargine in individuals with T2D on a basal-bolus regimen.



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Artikel online veröffentlicht:
02. Mai 2023

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