Evidence mapPaperPMID 39488821Full record

Trial reportClinical drug investigation2024

Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus.

Lisbet Westergaard, Lene Alifrangis, Stephen T Buckley, Hans Veit Coester, Thomas Klitgaard, Niels R Kristensen, Erica Nishimura, Lea Nørgreen, Thaís M P Rocha, Dorte B Steensgaard and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical drug investigation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03789578. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
field-weighted citation impact
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.

NCT03789578 phase1completed

A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes

Ran2019Enrolled30Registered outcomes22Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsNNC0148-0287, NNC0148-0287sema, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025
    Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. 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

12 authors.

Lisbet WestergaardNovo Nordisk, Development, Søborg, Denmark.
Lene AlifrangisNovo Nordisk, Research and Early Development, Måløv, Denmark.
Stephen T BuckleyNovo Nordisk, Research and Early Development, Måløv, Denmark.
Hans Veit CoesterProfil, Neuss, Germany.
Thomas KlitgaardNovo Nordisk, Research and Early Development, Måløv, Denmark.
Niels R KristensenNovo Nordisk, Development, Søborg, Denmark.
Erica NishimuraNovo Nordisk, Research and Early Development, Måløv, Denmark.
Lea NørgreenNovo Nordisk, Development, Aalborg, Denmark.
Thaís M P RochaNovo Nordisk, Development, Søborg, Denmark.
Dorte B SteensgaardNovo Nordisk, Research and Early Development, Måløv, Denmark.
Andreas VeggeNovo Nordisk, Research and Early Development, Måløv, Denmark.
Leona Plum-MörschelProfil, Neuss, Germany. leona.plum-moerschel@profil.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveIcoSema is being developed as a subcutaneous once-weekly fixed-ratio combination of the once-weekly basal insulin icodec and the once-weekly glucagon-like peptide-1 receptor agonist semaglutide. This study investigated the pharmacokinetics of icodec and semaglutide in IcoSema versus separate administration of each component in individuals with type 2 diabetes mellitus (T2DM).

methodsIn a randomised, double-blind, three-period crossover study, 31 individuals with T2DM (18-64 years, body weight 80-120 kg, glycosylated haemoglobin 6.0-8.5%) received single subcutaneous injections of IcoSema (175 U icodec, 0.5 mg semaglutide), icodec (175 U) or semaglutide (0.5 mg) with 6-9 weeks' washout. Pharmacokinetic blood samples were drawn up to 840 h post-dose.

resultsIcodec pharmacokinetics were unaffected by combining icodec with semaglutide. The 90% confidence interval (CI) of IcoSema/icodec was within 0.80-1.25 for total exposure (area under the curve from zero to last quantifiable observation; AUC

conclusionThe combination of icodec and semaglutide in IcoSema leads to a higher and earlier maximum semaglutide concentration, which will guide the dose recommendations for IcoSema. CLINICAL TRIAL: ClinicalTrials.gov identifier: NCT03789578.

Indexed as

Cross-Over StudiesDiabetes Mellitus, Type 2Glucagon-Like PeptidesHypoglycemic AgentsAdolescentAdultDouble-Blind MethodDrug Administration ScheduleDrug CombinationsFemaleHumansInjections, SubcutaneousInsulinMaleMiddle AgedSemaglutideDrug CombinationsGlucagon-Like PeptidesHypoglycemic AgentsInsulinSemaglutide

Identifiers

PMID39488821
PMCPMC11564230

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.