The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.
Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial
Open accessAbstract
Background ONWARDS 6 compared the efficacy and safety of once-weekly subcutaneous insulin icodec (icodec) and once-daily insulin degludec (degludec) in adults with type 1 diabetes. Methods This 52-week (26-week main phase plus a 26-week safety extension), randomised, open-label, treat-to-target, phase 3a trial was done at 99 sites across 12 countries. Adults with type 1 diabetes (glycated haemoglobin [HbA 1c ] <10·0% [86 mmol/mol]) were randomly assigned (1:1) to once-weekly icodec or once-daily degludec, both in combination with insulin aspart (two or more daily injections). The primary endpoint was change in HbA 1c from baseline to week 26, tested for non-inferiority (0·3 percentage point margin) in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, NCT04848480, and is now complete. Findings Between April 30 and Oct 15, 2021, of 655 participants screened, 582 participants were randomly assigned to icodec (n=290) or degludec (n=292). At week 26, from baseline values of 7·59% (icodec) and 7·63% (degludec), estimated mean changes in HbA 1c were −0·47 percentage points and −0·51 percentage points, respectively (estimated treatment difference 0·05 percentage points [95% CI −0·13 to 0·23]), confirming non-inferiority of icodec to degludec (p=0·0065). Overall rate of combined clinically significant or severe hypoglycaemia (baseline to week 26) was statistically significantly higher with icodec than degludec (19·9 vs 10·4 events per patient-year of exposure; estimated rate ratio 1·9 [95% CI 1·5 to 2·3]; p<0·0001). The rate was also statistically significantly higher with icodec than degludec when evaluated over 57 weeks (52 weeks plus a 5-week follow-up period). 39 serious adverse events were reported in 24 (8%) participants receiving icodec, and 25 serious adverse events were reported in 20 (7%) participants receiving degludec. One participant in the icodec group died; this was judged unlikely to be due to the trial product. Interpretation In adults with type 1 diabetes, once-weekly icodec showed non-inferiority to once-daily degludec in HbA 1c reduction at week 26, with statistically significantly higher rates of combined clinically significant or severe hypoglycaemia. For icodec, time below 3·0 mmol/L (<54 mg/dL) was at the threshold of the internationally recommended target (<1%) during weeks 22–26 and below target during weeks 48–52. Funding Novo Nordisk.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source doesn’t support the claim as written.
In the citing paper
“A randomised openlabel study of 582 adults with type 1 diabetes showed noninferiority of insulin icodec to daily insulin degludec at 26 weeks of treatment, with better outcomes at 52 weeks of treatment, although more clinically significant hypoglycaemic events occurred with insulin icodec.87”
From The future of type 1 diabetes therapy (2025) · cites this paper as [87]
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Of individuals identified with presymptomatic diabetes, approximately 85% have stage 1 and 15% stage 2.4”
From The future of type 1 diabetes therapy (2025) · cites this paper as [4]
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016–2018
Foster, N. C., Beck, R. W., Miller, K. M., Clements, M. A., Rickels, M. R., DiMeglio, L. A., Maahs, D. M., Tamborlane, W. V., Bergenstal, R., Smith, E., et al. (2019) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0384 · Cited by 1,907
9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2023
ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E., Isaacs, D., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s009 · Cited by 851
Continuous glucose monitoring and metrics for clinical trials: an international consensus statement
Battelino, T., Alexander, C. M., Amiel, S. A., Arreaza-Rubin, G., Beck, R. W., Bergenstal, R. M., Buckingham, B. A., Carroll, J., Ceriello, A., Chow, E., et al. (2023) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(22)00319-9 · Cited by 831
Self-citationHeller, S., Buse, J., Fisher, M., Garg, S., Marre, M., Merker, L., Renard, E., Russell-Jones, D., Philotheou, A., Francisco, A. M. O., et al. (2012) · The Lancet · doi:10.1016/s0140-6736(12)60204-9 · Cited by 402
Self-citationBradley, C., & Lewis, K. S. (1990) · Diabetic Medicine · doi:10.1111/j.1464-5491.1990.tb01421.x · Cited by 380
Mathieu, C., Hollander, P., Miranda-Palma, B., Cooper, J., Franek, E., Russell-Jones, D., Larsen, J., Tamer, S. C., Bain, S. C., & on behalf of the NN1250-3770 (BEGIN: Flex T1) Trial Investigators (2013) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2012-3249 · Cited by 219
Self-citationNishimura, E., Pridal, L., Glendorf, T., Hansen, B. F., Hubálek, F., Kjeldsen, T., Kristensen, N. R., Lützen, A., Lyby, K., Madsen, P., et al. (2021) · BMJ Open Diabetes Research & Care · doi:10.1136/bmjdrc-2021-002301 · Cited by 159
Renard, É., Ikegami, H., Vianna, A. G. D., Pozzilli, P., Brette, S., Bosnyák, Z., Lauand, F., Peters, A. L., Pilorget, V., Jurišić‐Eržen, D., et al. (2020) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3430 · Cited by 83
Philis‐Tsimikas, A., BAJAJ, H. S., Begtrup, K., Cailleteau, R., Gowda, A., Lingvay, I., Mathieu, C., Russell-Jones, D. L., & Rosenstock, J. (2022) · Diabetes Obesity and Metabolism · doi:10.1111/dom.14871 · Cited by 83
Self-citationKazda, C. M., Bue-Valleskey, J. M., Chien, J., Zhang, Q., Chigutsa, E., Landschulz, W., Wullenweber, P., Haupt, A., & Dahl, D. (2023) · Diabetes Care · doi:10.2337/dc22-2395 · Cited by 56
Cited by
Sorted by citations
Items 101–115 of 115
Glycemic management in adults with type 1 diabetes
Koliaki, C. C., & Liatis, S. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-13825-6.00317-4
NEW FORMS AND TECHNOLOGIES OF INSULIN THERAPY IN TYPE 1 DIABETES - A SYSTEMATIC LITERATURE REVIEW
Ogórek, A., Kaniak, A., Andrzejewska, J., Wińska, A., Pietruszewska, H., Czerepak, I., Majchrzak, I., Ziemba, M., Zackiewicz, K., & Zielska, J. (2025) · International Journal of Innovative Technologies in Social Science · doi:10.31435/ijitss.4(48).2025.4479
Hayashi, A., & Miyatsuka, T. (2025) · Nihon Naika Gakkai Zasshi · doi:10.2169/naika.114.610
Rendell, M. (2026) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2026.2686435
Drummond, R. F., Seif, K. E., & Reece, E. A. (2026) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2026.07.009
Patel, Y., Patel, R., & Raval, R. (2026) · Cureus · doi:10.7759/cureus.113509
Pancreas and pancreatic hormones: Insulin dosing behavior and “insulin metrics”
Xue, J., & Chang, X. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-30263-3.00006-3
Li, J., Wen, J., Zheng, H., Quan, C., Bi, J., Yang, Y., Zhang, J., & Shen, Y. (2026) · Frontiers in Endocrinology · doi:10.3389/fendo.2026.1902260
Ajjan, R., Battelino, T., Cos, X., Prato, S. D., Mathieu, C., Almehthel, M. S., Seufert, J., Guerci, B., & Seidu, S. (2026) · The Lancet Primary Care · doi:10.1016/j.lanprc.2026.100193
Self-citationKomma, S. A. K., & Ravula, T. N. P. K. (2026) · Research Square · doi:10.21203/rs.3.rs-10896785/v1
Holt, R. I. G., DeVries, J. H., Fischl, A. H., Hirsch, I. B., Kirkman, M. S., Klupa, T., Ludwig, B., Nørgaard, K., Pettus, J., Renard, É., et al. (2026) · Diabetologia · doi:10.1007/s00125-026-06833-z
Insulin Icodec in India: A Narrative Review of the First Once-Weekly Basal Insulin
Garg, R. (2026) · Global Journal of Guntur Medical College · doi:10.25259/gjgmc_19_2026
Antidiabetic medications in the pipeline
Efstathiadou, Z. A., Gogakos, A. I., Divaris, E., Kostopoulos, G., & Makri, E. (2026) · HORMONES · doi:10.1007/s42000-026-00780-5
Once-Weekly Insulin Icodec: A Review of its Pharmacokinetic and Pharmacodynamic Properties
Heise, T., Haridas, M. P., Kristensen, N. R., Mathieu, C., Ribel-Madsen, R., & Pieber, T. R. (2026) · Clinical Pharmacokinetics · doi:10.1007/s40262-026-01719-0
Self-citationRSSDI consensus statement on the use of diabetes technology in India
Kesavadev, J., Maheshwari, A., Gupta, S., Parikh, R. M., Viswanathan, V., Saboo, B., Joshi, S., Chawla, M. S., Gupta, A., Misra, A., et al. (2026) · International Journal of Diabetes in Developing Countries · doi:10.1007/s13410-026-01755-3
Metadata
- Authors
- Russell-Jones, D., Babazono, T., Cailleteau, R., Engberg, S., Irace, C., Kjaersgaard, M. I. S., Mathieu, C., Rosenstock, J., Woo, V., & Klonoff, D. C.
- Affiliations
- University of Surrey (GB)
- Tokyo Women's Medical University (JP)
- Novo Nordisk (Denmark) (DK)
- Magna Graecia University (IT)
- KU Leuven (BE)
- Velocity Clinical Research (United States) (US)
- University of Manitoba (CA)
- San Mateo Medical Center (US)
- Corresponding author
- Russell-Jones, David
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2023-11
- Volume
- 402
- Issue
- 10413
- Pages
- 1636-1647
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W4387710695
- Cited by
- 115
- References
- 14
- Citations by year
- 2026: 22 · 2025: 55 · 2024: 36 · 2023: 2
- FWCI
- 23.59
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Lirias (submittedVersion, cc-by)
- Funders
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- type 1 diabetes, insulin icodec, insulin degludec, multiple daily insulin injections, insulin aspart, HbA1c, non-inferiority, hypoglycemia, hypoglycemia risk, insulin dosing frequency
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Humans, Hypoglycemia, Hypoglycemic Agents, Treatment Outcome, Insulin, Long-Acting
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
