Once-Weekly Basal Insulin Icodec Offers Comparable Efficacy and Safety vs. Once-Daily Insulin Glargine U100 in Insulin-Naïve Patients with T2D Inadequately Controlled on OADS
Bibliographic record
Abstract
Insulin icodec (icodec) is a novel basal insulin analog in development as the first once-weekly insulin. This 26-week, randomized, double-blind, double-dummy, treat-to-target, phase 2 trial investigated the efficacy and safety of once-weekly icodec vs. once-daily insulin glargine U100 (IGlar U100) in insulin-naïve patients with T2D inadequately controlled (A1C 7.0-9.5%) with metformin±DPP-4i. Starting doses were 70 U weekly and 10 U daily, respectively, with weekly titration to a pre-breakfast SMBG target of 70-108 mg/dL. Primary endpoint was change in A1C from baseline to week 26. Secondary endpoints included change in FPG and hypoglycemic episodes. Participants (n=247) were randomized 1:1 to icodec (n=125) or IGlar U100 (n=122). Mean baseline A1C was 8.1% (icodec) and 8.0% (IGlar U100). At week 26, estimated mean A1C was 6.69% for icodec and 6.87% for IGlar U100 (estimated mean change from baseline: -1.33% and -1.15%-points, respectively). There was no statistically significant treatment difference for change in A1C from baseline to week 26 Estimated mean FPG at week 26 was 123 mg/dL (icodec) and 127 mg/dL (IGlar U100). Observed rates of level 2 (<54 mg/dL) + 3 (severe) hypoglycemia were low (60.55 and 52.36 events per 100 patient years of exposure for icodec and IGlar U100, respectively) and were comparable (p=0.85). Conclusion, icodec is the first once-weekly insulin with similar glucose-lowering effects and safety profile to once-daily IGlar U100. Icodec could improve treatment acceptance and facilitate T2D management in patients needing basal insulin. Publication History Article published online: 26 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".