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Record W4281661632 · doi:10.2337/db22-721-p

721-P: Insulin-Sparing Effects of Oral Semaglutide: An Analysis of PIONEER 8

2022· article· en· W4281661632 on OpenAlexaboutno aff
Vanita R. Aroda, MORTEN T. ABILDLUND, Rikke Mette Agesen, Stewart B. Harris, BANAFSHEH ZAHEDI, Bernard Zinman, Eiichi Araki

Bibliographic record

VenueDiabetes · 2022
Typearticle
Languageen
FieldMedicine
TopicDiabetes Treatment and Management
Canadian institutionsnot available
Fundersnot available
KeywordsSemaglutideInsulinMedicinePlaceboHypoglycemiaRandomizationInternal medicinePost-prandialEndocrinologyRandomized controlled trialDiabetes mellitusType 2 diabetes

Abstract

fetched live from OpenAlex

The PIONEER 8 (NCT03021187) trial demonstrated significant glucose-lowering efficacy of oral semaglutide vs. placebo (pbo) in patients (pts) with T2D inadequately controlled with insulin. Additionally, those assigned to oral semaglutide (7 or 14 mg daily) had a lower total daily insulin dose at end of treatment (week 52) relative to baseline, vs. those treated with pbo, suggesting an insulin-sparing effect. This post-hoc analysis of PIONEER 8 aimed to characterize the transition of adding a GLP-1RA to insulin therapy and to quantify reductions in total insulin dose seen with the addition of oral semaglutide. A 20% reduction in total daily insulin dose was recommended at randomization up to week 8. Total daily insulin was not to exceed pre-randomization dose between weeks 8 and 26 but was freely adjustable at the investigator’s discretion from week 26 to 52. For all doses of oral semaglutide, a greater proportion of pts were able to maintain a greater level of insulin dose reduction vs. pbo at week 26 (Figure) . Greater proportions of pts on oral semaglutide 3, 7, and 14 mg achieved ≥20% reductions in insulin vs. those in the pbo group at both weeks 26 and 52 (Treatment policy estimand; 27.5%, 28.9%, 31.2% vs. 12.4% and 19.5%, 25.0%, 32.0% vs 5.7%, respectively; P<0.0 for all) . Addition of oral semaglutide in pts with T2D permits a significant reduction in insulin dose, which may provide benefits (e.g. lower risk of hypoglycemia and weight gain) long-term. Disclosure V.R.Aroda: Consultant; Applied Therapeutics, Fractyl Health, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Other Relationship; Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Research Support; Applied Therapeutics, Fractyl Health, Inc., Novo Nordisk, Sanofi. M.T.Abildlund: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. R.Agesen: Employee; Novo Nordisk A/S. S.B.Harris: Consultant; Abbott, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Other Relationship; Abbott, AstraZeneca, Bayer Inc., Dexcom, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Research Support; Applied Therapeutics Inc., AstraZeneca, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF) , Novo Nordisk, Sanofi, The Lawson Foundation. B.Zahedi: Employee; Novo Nordisk A/S. B.Zinman: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi K.K. E.Araki: Other Relationship; Astellas Pharma Inc., Daiichi Sankyo, Eli Lilly and Company, Kowa Company, Ltd., Merck & Co., Inc., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Novo Nordisk, Sanofi K.K., Taisho Pharmaceutical Holdings Co., Ltd., Takeda Pharmaceutical Company Limited, Terumo Corporation, Speaker's Bureau; Abbott, AstraZeneca, Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co., Ltd., Sanwa Kagaku Kenkyusho. Funding Funded by Novo Nordisk A/S

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.005
metaresearch head score (Gemma)0.003
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.007
Threshold uncertainty score0.024

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0050.003
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0030.005
Bibliometrics0.0000.001
Science and technology studies0.0000.001
Scholarly communication0.0010.001
Open science0.0010.001
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0070.001

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.

Opus teacher head0.010
GPT teacher head0.247
Teacher spread0.237 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

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".

Quick stats

Citations0
Published2022
Admission routes1
Has abstractyes

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