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.

Westergaard L, Alifrangis L, Buckley ST, Coester HV, Klitgaard T, Kristensen NR, Nishimura E, Nørgreen L, Rocha TMP, Steensgaard DB, Vegge A, Plum-Mörschel L

Clinical drug investigation3 Nov 2024Cited by 11 (Europe PMC)

PMID39488821PMCIDPMC11564230DOI10.1007/s40261-024-01405-8PepBankPUB-39488821

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

1 result from studies that gave the peptide. 1 result from people.

01HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, a single 0.5 mg subcutaneous dose of semaglutide was well tolerated.
In plain wordsIn adults with type 2 diabetes, a single dose of semaglutide was well tolerated.
Peptide
Semaglutide
Outcome
No significant changeTolerability of single-dose semaglutide
Study
n = 31
Outcome group
Adverse events · Whole body
Studied dose
0.5 mg · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
IcoSema, icodec and semaglutide were well-tolerated
1 context sentence(design, population, supporting numbers)
Summary · context
In 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.
Report a problemFND-3948882105

Studies that did not test the peptide alone5

In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Semaglutide.

02HumanNot a test of Semaglutide aloneRandomized controlled trialPharmacokinetics
In adults with type 2 diabetes, semaglutide total exposure after the icodec-semaglutide combination IcoSema was unaffected compared with semaglutide alone.
In plain wordsIn adults with type 2 diabetes, the IcoSema combination gave about the same total semaglutide exposure as semaglutide alone.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide total exposure (AUC0-t) in IcoSema versus semaglutide alone
Study
n = 31
Comparator
Semaglutide alone
Outcome group
Pharmacokinetics · Pharmacology
Measurements
AUC0-t ratio
1.11
IcoSema/semaglutide
Source sentences
Summary
Semaglutide AUC_0-t was also unaffected by combination with icodec (IcoSema/semaglutide 1.11 [1.05; 1.17]).
1 context sentence(design, population, supporting numbers)
Summary · context
In 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.
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3948882101
03HumanNot a test of Semaglutide aloneRandomized controlled trialPharmacokinetics
In adults with type 2 diabetes, semaglutide maximum concentration was higher after the icodec-semaglutide combination IcoSema than after semaglutide alone.
In plain wordsIn adults with type 2 diabetes, the IcoSema combination gave a higher peak semaglutide level than semaglutide alone.
Peptide
Semaglutide
Outcome
IncreaseSemaglutide maximum concentration (Cmax) in IcoSema versus semaglutide alone
Study
n = 31
Comparator
Semaglutide alone
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Cmax ratio
1.99
IcoSema/semaglutide
Source sentences
Summary
However, semaglutide C_max was higher for IcoSema versus semaglutide alone (IcoSema/semaglutide 1.99 [1.84; 2.15])
1 context sentence(design, population, supporting numbers)
Summary · context
In 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.
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3948882102
04HumanNot a test of Semaglutide aloneRandomized controlled trialPharmacokinetics
In adults with type 2 diabetes, semaglutide maximum concentration occurred earlier after the icodec-semaglutide combination IcoSema than after semaglutide alone.
In plain wordsIn adults with type 2 diabetes, semaglutide peaked sooner with the IcoSema combination than with semaglutide alone.
Peptide
Semaglutide
Outcome
DecreaseTime to semaglutide maximum concentration in IcoSema versus semaglutide alone
Study
n = 31
Comparator
Semaglutide alone
Outcome group
Pharmacokinetics · Pharmacology
Measurements
Time to Cmax
12 h
IcoSema
Time to Cmax
84 h
semaglutide alone
Source sentences
Summary
and occurred earlier for IcoSema (12 versus 84 h).
1 context sentence(design, population, supporting numbers)
Summary · context
In 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.
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3948882103
05HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, more gastrointestinal adverse events occurred with the icodec-semaglutide combination IcoSema than with icodec or semaglutide alone.
In plain wordsIn adults with type 2 diabetes, the IcoSema combination caused more stomach and gut side effects than icodec or semaglutide alone.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal adverse events with IcoSema
Study
n = 31
Comparator
Icodec alone or semaglutide alone (pooled)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
more gastrointestinal related adverse events occurred with IcoSema versus icodec or semaglutide alone.
1 context sentence(design, population, supporting numbers)
Summary · context
In 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.
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3948882104
06AnimalNot a test of Semaglutide aloneAnimal study (in vivo)Mechanism
In albumin binding and animal pharmacokinetic studies, the changed semaglutide absorption in IcoSema was attributed to competition for albumin binding at the injection site, with icodec outcompeting semaglutide.
In plain wordsIn lab and animal tests, icodec appeared to outcompete semaglutide for albumin binding at the injection site, changing how semaglutide was absorbed from IcoSema.
Peptide
Semaglutide
Outcome
Not applicableMechanism of changed semaglutide absorption in IcoSema
Study
n: not reported in source
in vitro albumin binding studies and animal pharmacokinetic studies
Outcome group
Receptor activity and mechanism · Pharmacology
Source sentences
Summary
Results of in vitro albumin binding studies and animal pharmacokinetic studies supported that the change in semaglutide absorption pharmacokinetics in IcoSema is owing to competition for albumin binding locally at the injection site with icodec outcompeting semaglutide.
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Report a problemFND-3948882106

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 1NCT03789578

A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

Novo Nordisk A/Sn = 3017 Jan 2019 to 10 Oct 2019

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 12 Nov 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.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
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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