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Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin

Julio Rosenstock Orcid Logo, Steve Bain Orcid Logo, Amoolya Gowda, Esteban Jódar, Bo Liang, Ildiko Lingvay Orcid Logo, Tomoyuki Nishida, Roberto Trevisan, Ofri Mosenzon

New England Journal of Medicine, Volume: 389, Issue: 4, Pages: 297 - 308

Swansea University Author: Steve Bain Orcid Logo

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DOI (Published version): 10.1056/nejmoa2303208

Abstract

Background: Insulin icodec is an investigational once-weekly basal insulin analogue for diabetes management. Methods: We conducted a 78-week randomized, open-label, treat-to-target phase 3a trial (including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period) involving...

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Published in: New England Journal of Medicine
ISSN: 0028-4793 1533-4406
Published: Massachusetts Medical Society 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa63791
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Methods: We conducted a 78-week randomized, open-label, treat-to-target phase 3a trial (including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period) involving adults with type 2 diabetes (glycated hemoglobin level, 7 to 11%) who had not previously received insulin. Participants were randomly assigned in a 1:1 ratio to receive once-weekly insulin icodec or once-daily insulin glargine U100. The primary end point was the change in the glycated hemoglobin level from baseline to week 52; the confirmatory secondary end point was the percentage of time spent in the glycemic range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) in weeks 48 to 52. Hypoglycemic episodes (from baseline to weeks 52 and 83) were recorded. Results: Each group included 492 participants. Baseline characteristics were similar in the two groups. The mean reduction in the glycated hemoglobin level at 52 weeks was greater with icodec than with glargine U100 (from 8.50% to 6.93% with icodec [mean change, -1.55 percentage points] and from 8.44% to 7.12% with glargine U100 [mean change, -1.35 percentage points]); the estimated between-group difference (-0.19 percentage points; 95% confidence interval [CI], -0.36 to -0.03) confirmed the noninferiority (P&lt;0.001) and superiority (P = 0.02) of icodec. The percentage of time spent in the glycemic range of 70 to 180 mg per deciliter was significantly higher with icodec than with glargine U100 (71.9% vs. 66.9%; estimated between-group difference, 4.27 percentage points [95% CI, 1.92 to 6.62]; P&lt;0.001), which confirmed superiority. Rates of combined clinically significant or severe hypoglycemia were 0.30 events per person-year of exposure with icodec and 0.16 events per person-year of exposure with glargine U100 at week 52 (estimated rate ratio, 1.64; 95% CI, 0.98 to 2.75) and 0.30 and 0.16 events per person-year of exposure, respectively, at week 83 (estimated rate ratio, 1.63; 95% CI, 1.02 to 2.61). No new safety signals were identified, and incidences of adverse events were similar in the two groups. 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spelling v2 63791 2023-07-06 Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin 5399f4c6e6a70f3608a084ddb938511a 0000-0001-8519-4964 Steve Bain Steve Bain true false 2023-07-06 BMS Background: Insulin icodec is an investigational once-weekly basal insulin analogue for diabetes management. Methods: We conducted a 78-week randomized, open-label, treat-to-target phase 3a trial (including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period) involving adults with type 2 diabetes (glycated hemoglobin level, 7 to 11%) who had not previously received insulin. Participants were randomly assigned in a 1:1 ratio to receive once-weekly insulin icodec or once-daily insulin glargine U100. The primary end point was the change in the glycated hemoglobin level from baseline to week 52; the confirmatory secondary end point was the percentage of time spent in the glycemic range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) in weeks 48 to 52. Hypoglycemic episodes (from baseline to weeks 52 and 83) were recorded. Results: Each group included 492 participants. Baseline characteristics were similar in the two groups. The mean reduction in the glycated hemoglobin level at 52 weeks was greater with icodec than with glargine U100 (from 8.50% to 6.93% with icodec [mean change, -1.55 percentage points] and from 8.44% to 7.12% with glargine U100 [mean change, -1.35 percentage points]); the estimated between-group difference (-0.19 percentage points; 95% confidence interval [CI], -0.36 to -0.03) confirmed the noninferiority (P<0.001) and superiority (P = 0.02) of icodec. The percentage of time spent in the glycemic range of 70 to 180 mg per deciliter was significantly higher with icodec than with glargine U100 (71.9% vs. 66.9%; estimated between-group difference, 4.27 percentage points [95% CI, 1.92 to 6.62]; P<0.001), which confirmed superiority. Rates of combined clinically significant or severe hypoglycemia were 0.30 events per person-year of exposure with icodec and 0.16 events per person-year of exposure with glargine U100 at week 52 (estimated rate ratio, 1.64; 95% CI, 0.98 to 2.75) and 0.30 and 0.16 events per person-year of exposure, respectively, at week 83 (estimated rate ratio, 1.63; 95% CI, 1.02 to 2.61). No new safety signals were identified, and incidences of adverse events were similar in the two groups. Conclusions: Glycemic control was significantly better with once-weekly insulin icodec than with once-daily insulin glargine U100. Journal Article New England Journal of Medicine 389 4 297 308 Massachusetts Medical Society 0028-4793 1533-4406 27 7 2023 2023-07-27 10.1056/nejmoa2303208 http://dx.doi.org/10.1056/nejmoa2303208 COLLEGE NANME Biomedical Sciences COLLEGE CODE BMS Swansea University Novo Nordisk (ONWARDS 1 ClinicalTrials.gov number, NCT04460885). 2024-02-02T08:28:56.4809625 2023-07-06T14:06:27.9350502 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Julio Rosenstock 0000-0001-8324-3275 1 Steve Bain 0000-0001-8519-4964 2 Amoolya Gowda 3 Esteban Jódar 4 Bo Liang 5 Ildiko Lingvay 0000-0001-7006-7401 6 Tomoyuki Nishida 7 Roberto Trevisan 8 Ofri Mosenzon 9 63791__28047__c17bbbb1abb6487cac47899d8e97e871.pdf Rosenstock2023.pdf 2023-07-06T14:07:24.9627098 Output 369987 application/pdf Accepted Manuscript true 2023-12-24T00:00:00.0000000 true eng
title Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
spellingShingle Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
Steve Bain
title_short Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
title_full Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
title_fullStr Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
title_full_unstemmed Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
title_sort Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
author_id_str_mv 5399f4c6e6a70f3608a084ddb938511a
author_id_fullname_str_mv 5399f4c6e6a70f3608a084ddb938511a_***_Steve Bain
author Steve Bain
author2 Julio Rosenstock
Steve Bain
Amoolya Gowda
Esteban Jódar
Bo Liang
Ildiko Lingvay
Tomoyuki Nishida
Roberto Trevisan
Ofri Mosenzon
format Journal article
container_title New England Journal of Medicine
container_volume 389
container_issue 4
container_start_page 297
publishDate 2023
institution Swansea University
issn 0028-4793
1533-4406
doi_str_mv 10.1056/nejmoa2303208
publisher Massachusetts Medical Society
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
url http://dx.doi.org/10.1056/nejmoa2303208
document_store_str 1
active_str 0
description Background: Insulin icodec is an investigational once-weekly basal insulin analogue for diabetes management. Methods: We conducted a 78-week randomized, open-label, treat-to-target phase 3a trial (including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period) involving adults with type 2 diabetes (glycated hemoglobin level, 7 to 11%) who had not previously received insulin. Participants were randomly assigned in a 1:1 ratio to receive once-weekly insulin icodec or once-daily insulin glargine U100. The primary end point was the change in the glycated hemoglobin level from baseline to week 52; the confirmatory secondary end point was the percentage of time spent in the glycemic range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) in weeks 48 to 52. Hypoglycemic episodes (from baseline to weeks 52 and 83) were recorded. Results: Each group included 492 participants. Baseline characteristics were similar in the two groups. The mean reduction in the glycated hemoglobin level at 52 weeks was greater with icodec than with glargine U100 (from 8.50% to 6.93% with icodec [mean change, -1.55 percentage points] and from 8.44% to 7.12% with glargine U100 [mean change, -1.35 percentage points]); the estimated between-group difference (-0.19 percentage points; 95% confidence interval [CI], -0.36 to -0.03) confirmed the noninferiority (P<0.001) and superiority (P = 0.02) of icodec. The percentage of time spent in the glycemic range of 70 to 180 mg per deciliter was significantly higher with icodec than with glargine U100 (71.9% vs. 66.9%; estimated between-group difference, 4.27 percentage points [95% CI, 1.92 to 6.62]; P<0.001), which confirmed superiority. Rates of combined clinically significant or severe hypoglycemia were 0.30 events per person-year of exposure with icodec and 0.16 events per person-year of exposure with glargine U100 at week 52 (estimated rate ratio, 1.64; 95% CI, 0.98 to 2.75) and 0.30 and 0.16 events per person-year of exposure, respectively, at week 83 (estimated rate ratio, 1.63; 95% CI, 1.02 to 2.61). No new safety signals were identified, and incidences of adverse events were similar in the two groups. Conclusions: Glycemic control was significantly better with once-weekly insulin icodec than with once-daily insulin glargine U100.
published_date 2023-07-27T08:28:56Z
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