Evidence mapPaperPMID 30047216Full record

Trial reportDiabetes, obesity & metabolism2019

Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach.

Rune V Overgaard, Søren Ø Lindberg, Desirée Thielke

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01885208. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01885208 phase3completed

Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)

Ran2013Enrolled813Registered outcomes6Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2Armsexenatide, semaglutide
Open the trial in the graph
NCT02054897 phase3completed

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Ran2014Enrolled388Registered outcomes6Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
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  11. Review
  12. Article
  13. Switching Between Glucagon-Like Peptide-1 Receptor Agonists: Rationale and Practical Guidance.Clinical diabetes : a publication of the American Diabetes Association · 2020
    Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Rune V OvergaardDepartment of Quantitative Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.ORCID 0000-0001-7095-4270
Søren Ø LindbergDepartment of Medical and Science, Novo Nordisk A/S, Søborg, Denmark.
Desirée ThielkeDepartment of Global Medical Affairs, Novo Nordisk A/S, Søborg, Denmark.
Novo Nordisk (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSemaglutide is a glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. The impact of switching treatment from another GLP-1 receptor agonist (GLP-1RA) to semaglutide was investigated by analyses of exposure-response models.

methodsHbA1c and body weight time-course models were developed, using up to 30 weeks of observations from four trials in the semaglutide phase 3 programme. Given the recommended dosing for each GLP-1RA, pharmacokinetic profiles were simulated based on published population pharmacokinetic models and exposure was adjusted by the relative potencies to ensure that model predictions matched the effects observed in clinical trials. After 26 weeks of simulated treatment with liraglutide, dulaglutide or exenatide extended-release, simulated semaglutide treatment was initiated 1 day after the last once-daily dose of liraglutide and 1 week after the last once-weekly doses of dulaglutide or exenatide extended-release.

resultsThe potency-adjusted total effective GLP-1RA concentration increased after switching from another GLP-1RA to semaglutide and was associated with reductions ranging from ~0.3% to ~0.8%-points for HbA1c and from ~2% to ~4% for body weight with semaglutide 1.0 mg. Temporary slight deteriorations in HbA1c were observed after switching to semaglutide 0.25 mg from liraglutide 1.2/1.8 mg or dulaglutide 1.5 mg.

conclusionsExposure-response modelling suggests that switching to semaglutide from liraglutide, dulaglutide or exenatide extended-release results in further reductions in HbA1c and body weight. Initial slight deterioration in outcome values when switching to semaglutide 0.25 mg could be avoided by initiating semaglutide treatment at a higher dose.

Indexed as

Glucagon-Like PeptidesHypoglycemic AgentsAdultAgedBody WeightDiabetes Mellitus, Type 2FemaleGlucagon-Like Peptide-1 Receptor AgonistsGlycated HemoglobinHumansMaleMiddle AgedModels, StatisticalSemaglutideGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsSemaglutideantidiabetic drugGLP-1GLP-1 analoguepopulation studytype 2 diabetes

Identifiers

PMID30047216
PMCPMC6585654
OpenAlexW2883897596

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.