800-P: Predictors of HbA1c and dTIR Responses with iGlarLixi in Type 2 Diabetes—Patient-Level Exploratory Analyses of the LixiLan-L Trial
Bibliographic record
Abstract
We aimed to evaluate derived Time in Range (dTIR) and identify predictors for achieving HbA1c and dTIR targets after commencing iGlarLixi in people with type 2 diabetes (T2D). These exploratory analyses of LixiLan-L, an open-label, randomized trial, included people with T2D advancing from basal insulin ± oral agents. dTIR (70−180 mg/dL), derived Time above Range (dTAR, >180 mg/dL), and derived Time below Range (dTBR, <70 mg/dL) were calculated from the 7-point SMBG profiles. HbA1c and dTIR were assessed at Week 30. Predictive factors for achieving targets were analyzed with univariable and multivariable stepwise logistic regression. Participants receiving iGlarLixi (n=366) showed an increase in dTIR from 64% at baseline (BL) to 82%, with 66% achieving dTIR ≥70% and 50% achieving clinically significant improvements (≥5% dTIR) at Week 30. The dTIR >70%, dTBR <4%, and dTAR <25% triple target was attained by 54% of participants receiving iGlarLixi. Weight change from BL, and lower HbA1c and total daily insulin dose at BL were predictors for attaining HbA1c <7.0%; lower BL HbA1c was a predictor of dTIR ≥70% (Table). In conclusion, iGlarLixi is associated with clinically significant HbA1c and dTIR improvements in T2D advancing from basal insulin. Lower BL HbA1c predicted achieving HbA1c <7.0% and dTIR ≥70% goals, whereas lower BL insulin dose predicted achieving HbA1c <7.0% only. Disclosure M.Haluzik: Advisory Panel; Novo Nordisk, Lilly Diabetes, Boehringer-Ingelheim, Research Support; Sanofi, Speaker's Bureau; Abbott, AstraZeneca. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. A.Y.Cheng: Advisory Panel; Merck & Co., Inc., Pfizer Inc., GlaxoSmithKline plc., Other Relationship; Diabetes Canada, Research Support; Applied Therapeutics Inc., Speaker's Bureau; Abbott, AstraZeneca, Bayer Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., HLS Therapeutics Inc., Medtronic, Novo Nordisk, Sanofi, Insulet Corporation, Dexcom, Inc., Bausch Health, Canada. M.Al-sofiani: Consultant; Eli Lilly and Company, Speaker's Bureau; Sanofi, Medtronic, Vitalair. F.Lauand: Employee; Sanofi. L.Melas-melt: None. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi
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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 | 0.009 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".