803-P: Superior Glycemic Control with Once-Weekly Insulin Icodec with a Dosing Guide App vs. Once-Daily (OD) Basal Insulin Analogs in Insulin-Naïve T2D—ONWARDS 5
Bibliographic record
Abstract
ONWARDS 5 (NCT04760626), a 52-week, open-label, randomized, phase 3a trial with real-world elements, assessed effectiveness and safety of once-weekly insulin icodec with a dosing guide app (icodec) vs OD basal insulin analogs (degludec, glargine U100 or glargine U300) in insulin-naïve adults with T2D. Participants (mean: 59.3 yrs; 32.8 kg/m2) were randomized 1:1 to icodec or OD analogs. The dose guidance app aided icodec titration; OD analogs were titrated as per standard of care. Estimated mean A1C change from baseline (BL) to week 52 was greater with icodec (-1.68%-points, BL 9.0%) vs OD analogs (-1.31%-points, BL 8.9%) confirming non-inferiority (p<0.0001) and superiority (p=0.009) of icodec vs OD analogs. Patient-reported outcomes (DTSQ and TRIM-D) were statistically significant in favor of icodec vs OD analogs at week 52. Rates of level 2 (<54 mg/dL) or level 3 (severe) hypoglycemia were low for both treatments (0.19 [icodec] vs 0.14 [OD analogs] events per person-year of exposure). There were no significant differences between treatments in time to treatment discontinuation/intensification. Overall, icodec with a dosing guide app showed superiority in A1C reduction, and significant improvement in treatment satisfaction and compliance scores vs OD analogs, with low hypoglycemia rates, in insulin-naïve adults with T2D in a real-world setting. Disclosure H.S.Bajaj: Research Support; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Anji Pharmaceuticals, Eli Lilly and Company, Kowa Company, Ltd., Novo Nordisk, Pfizer Inc., Sanofi, Tricida, Inc. J.Aberle: Advisory Panel; Novo Nordisk, Speaker's Bureau; Novo Nordisk. M.J.Davies: Advisory Panel; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Lexicon Pharmaceuticals, Inc., Pfizer Inc., Medtronic, ShouTi Pharma Inc., Consultant; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Research Support; AstraZeneca, Novo Nordisk, Sanofi-Aventis U.S., Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., Speaker's Bureau; Lilly, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Napp Pharmaceuticals Limited, Novartis, Sanofi. A.M.Donatsky: Employee; Novo Nordisk. M.Frederiksen: Employee; Novo Nordisk A/S. D.Gogas yavuz: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk, Boehringer-Ingelheim. A.Gowda: Employee; Novo Nordisk A/S. I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. B.W.Bode: Advisory Panel; Ascensia Diabetes Care, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Research Support; Abbott Diabetes, Abvance Therapeutics, Better Therapeutics, Inc, Dexcom, Inc., Diasome, Dompé, Insulet Corporation, Lilly Diabetes, Medtronic, Novo Nordisk, Sanvita Medical, Senseonics, Provention Bio, Inc., REMD Biotherapeutics, ViaCyte, Inc., Xeris Pharmaceuticals, Inc., vTv Therapeutics, Speaker's Bureau; Abbott Diabetes, American Diabetes Association, Boehringer Ingelheim and Eli Lilly Alliance, Insulet Corporation, Lilly Diabetes, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; Glytec, LLC. Funding Novo Nordisk A/S
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.014 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".