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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".