Impact of Background Antihyperglycemic Therapy on Insulin Glargine 300 U/mL (Gla-300) vs. Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People with T2DM from the BRIGHT Randomized Study
Bibliographic record
Abstract
BRIGHT (NCT02738151), the first head-to-head trial of Gla-300 and IDeg-100 in T2DM, is a multicenter, open-label, randomized, parallel-group, 24-week actively controlled study, conducted in insulin-naïve participants uncontrolled on current antihyperglycemic drugs. Participants (mean baseline HbA1c 8.6%, diabetes duration 10.6 years, BMI 31.5 kg/m2) received Gla-300 (N=466) or IDeg-100 (N=463), titrated to a fasting SMPG of 80-100 mg/dL, and remained on metformin ± previous antihyperglycemic therapy. Primary endpoint: change in HbA1c from baseline to week 24; safety endpoints included hypoglycemia incidence. Here we report HbA1c and hypoglycemia outcomes by background antihyperglycemic therapy (no comparisons were performed for metformin as it was received by 92% of participants). Overall distribution of background therapy was: SU/Glinides (65.7%/2.3%), DPP-4i (24.4%), SGLT2i (13.3%), GLP-1 RA (11.9%). No evidence of heterogeneity of treatment effect according to use of background antihyperglycemic therapy on HbA1c reductions (Table), or incidence of confirmed (≤70 mg/dL or <54 mg/dL) or severe hypoglycemia was shown (all p>0.05). In conclusion, background antihyperglycemic therapies had no impact on the comparable efficacy and hypoglycemia profiles of Gla-300 and IDeg-100. Disclosure R. Roussel: Advisory Panel; Self; AbbVie Inc., Abbott, Eli Lilly and Company, Sanofi, Novo Nordisk A/S, AstraZeneca. Speaker's Bureau; Self; Servier. Consultant; Self; Bayer AG. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Amgen Inc., Sanofi, Novo Nordisk A/S, Danone Research. Stock/Shareholder; Self; Iriade. Advisory Panel; Self; Physiogenex S.A.S. J. Rosenstock: Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Consultant; Self; Sanofi. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Merck & Co., Inc., Pfizer Inc., Sanofi, Novo Nordisk Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Intarcia Therapeutics, Inc., Genentech, Inc. J. Pettus: Advisory Panel; Self; Sanofi, Novo Nordisk Inc.. Consultant; Self; MannKind Corporation. Advisory Panel; Self; Insulet Corporation. Consultant; Self; Senseonics. R. Ritzel: Speaker's Bureau; Self; AstraZeneca. Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Consultant; Self; Servier. Speaker's Bureau; Self; Bristol-Myers Squibb Company, Merck Sharp & Dohme Corp., Boehringer Ingelheim GmbH, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. A. Cheng: Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Abbott. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Consultant; Self; Takeda Canada Inc.. Research Support; Self; Sanofi, Boehringer Ingelheim GmbH. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. C. Devisme: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. A.M. Cali: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. X. Wang: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. G.B. Bolli: Speaker's Bureau; Self; Menarini Group, Sanofi. Research Support; Self; 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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 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".