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Study · Observational study · 2025

2 results

Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care.

Kattinakere Sreedhara S, Schneeweiss S, D'Andrea E, Weberpals JG, DiCesare EC, Patorno E, Tsacogianis T, Bradley M, Concato J, Wang SV

BMJ open diabetes research & care29 Oct 2025

PMID41161770 (opens in a new tab)PMCIDPMC12574359 (opens in a new tab)DOI10.1136/bmjdrc-2025-005180 (opens in a new tab)PepBankPUB-41161770
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Summary

ObjectiveUsing national claims databases, we sought to emulate the design of the ongoing SEPRA trial and predict its findings, comparing the effects of once weekly semaglutide to SoC medications on glycemic control (A1C <7%) in type-2 diabetes mellitus (T2D).Research design and methodsUsing Optum Clinformatics (July 2017 - May 2022), we identified a 1:1 propensity score-matched (PSM) cohort of adults with T2D on metformin monotherapy, who had recorded A1C and initiated either injectable semaglutide or SoC medications (dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, SUs, or glucagon-like peptide-1 agonists) and met eligibility criteria adapted from the SEPRA trial. The primary outcome was the proportion of patients achieving A1C <7%. The study protocol was preregistered (NCT05577728, ClinicalTrials.gov) before any etiologic analyses. Risk ratios and corresponding 95% CIs were estimated.ResultsWe identified 1,144 PSM pairs of injectable semaglutide and SoC initiators with balance in pre-exposure covariates. Semaglutide initiators were 30% (risk ratio (95% CI), 1.30 (1.16 to 1.45)) more likely to achieve glycemic control (A1C <7%) than those initiating SoC. Additionally, semaglutide initiators had a 1.3% reduction in A1C, compared with a 1.1% reduction in the SoC group. These results were consistent with interim results of the SEPRA trial, which were released after the protocol for our database study was preregistered.ConclusionThis claims database study, designed to predict the results of the SEPRA trial, found results consistent with interim trial results. Our findings support the notion that well-designed non-randomized studies using fit-for-purpose data can effectively complement pragmatic randomized controlled trials.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes on metformin, injectable semaglutide initiators were 30% more likely to reach A1C below 7% than standard-of-care initiators.

    In plain wordsIn adults with diabetes on metformin, people starting injectable semaglutide were 30% more likely to reach A1C below 7% than those on standard drugs.

    Peptide
    Semaglutide
    Outcome
    IncreaseProportion achieving A1C below 7%
    Study

    n: not reported in source

    Comparator
    Standard-of-care glucose-lowering drugs
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · injectableAs given in this study (human).

    Measurements

    Risk ratio
    1.3
    A1C <7%

    Source sentences

    Summary
    Semaglutide initiators were 30% (risk ratio (95% CI), 1.30 (1.16 to 1.45)) more likely to achieve glycemic control (A1C <7%) than those initiating SoC.
    1 context sentence
    Summary · context
    we identified a 1:1 propensity score-matched (PSM) cohort of adults with T2D on metformin monotherapy
  2. 02HumanObservational studyEfficacy outcome

    In adults with type 2 diabetes on metformin, injectable semaglutide initiators had a 1.3% reduction in A1C, compared with 1.1% with standard of care.

    In plain wordsIn adults with type 2 diabetes on metformin, A1C fell 1.3% with injectable semaglutide and 1.1% with standard drugs.

    Peptide
    Semaglutide
    Outcome
    DecreaseA1C reduction
    Study

    n: not reported in source

    Comparator
    Standard-of-care glucose-lowering drugs
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · injectableAs given in this study (human).

    Measurements

    A1C reduction
    1.3%
    semaglutide
    A1C reduction
    1.1%
    standard of care

    Source sentences

    Summary
    Additionally, semaglutide initiators had a 1.3% reduction in A1C, compared with a 1.1% reduction in the SoC group.
    1 context sentence
    Summary · context
    we identified a 1:1 propensity score-matched (PSM) cohort of adults with T2D on metformin monotherapy

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT05577728

Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data

Brigham and Women's Hospitaln = 2,3161 Jul 2021 to 31 Oct 2022

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 25 Sept 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:04 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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