Evidence map›Paper›PMID 42814374›Full record

ArticleClinical pharmacokinetics2026

The Effect of Intrinsic Factors on the Pharmacokinetics of Once-Weekly Insulin Icodec in Type 1 and Type 2 Diabetes: A Population Pharmacokinetic Analysis of Phase II and Phase III trials.

Niels R Kristensen, Mundot P Haridas, Athena Philis-Tsimikas, Rasmus Ribel-Madsen, Chantal Mathieu

5 registry-linked trialsAbstract read
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In one paragraph

Article in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03751657. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03751657 phase2completed

An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus

Ran2018Enrolled247Registered outcomes16Posted comparisons2ConditionsDiabetes Mellitus, Type 2ArmsDipeptidyl peptidase-4 inhibitors, Insulin glargine, Insulin icodec, Metformin, Placebo (insulin 287)
Open the trial in the graph
NCT04770532 phase3completednot on this map

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2022Enrolled526ConditionsDiabetes Mellitus, Type 2ArmsInsulin degludec, Insulin Icodec
NCT04795531 phase3completednot on this map

A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2022Enrolled588ConditionsDiabetes Mellitus, Type 2ArmsInsulin icodec, Placebo insulin icodec, Insulin degludec, Placebo insulin degludec
NCT04848480 phase3completednot on this map

Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2022Enrolled582ConditionsDiabetes Mellitus, Type 1Armsinsulin icodec, insulin degludec, insulin aspart
NCT04880850 phase3completednot on this map

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen

TypeinterventionalSponsorNovo Nordisk A/SRan2021 to 2022Enrolled582ConditionsDiabetes Mellitus, Type 2ArmsInsulin icodec, Insulin glargine, Insulin aspart
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Niels R KristensenNovo Nordisk, Søborg, Denmark. nikr@novonordisk.com.ORCID http://orcid.org/0000-0001-8582-6298
Mundot P HaridasNovo Nordisk, Bangalore, India.
Athena Philis-TsimikasScripps Whittier Diabetes Institute, La Jolla, CA, USA.
Rasmus Ribel-MadsenNovo Nordisk, Søborg, Denmark.
Chantal MathieuClinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveInsulin icodec is a novel basal insulin with pharmacokinetic and pharmacodynamic properties suitable for once-weekly administration. This study evaluated the effect of several intrinsic factors on icodec exposure using population pharmacokinetic modelling.

methodsData for the population pharmacokinetic analysis originated from one phase II and four phase III randomised, parallel-group, treat-to-target clinical trials comparing the efficacy and safety of icodec with once-daily comparators in type 1 or type 2 diabetes. A total of 1244 participants each contributed with up to seven pharmacokinetic samples during 26 weeks of icodec treatment. A one-compartment pharmacokinetic model with first-order absorption and elimination was used to estimate potential effects of individual covariates on apparent clearance.

resultsThere were minor or no effects of age, sex, type of diabetes, race, ethnicity, serum albumin level or anti-insulin icodec antibody level on icodec exposure. For all these covariates, the 90% confidence intervals for the icodec exposure ratio versus a reference individual were within the equivalence limits of 0.80-1.25. Icodec exposure was inversely correlated with body weight. However, the effect of body weight was of a magnitude not considered clinically relevant given that icodec, consistent with any other insulin, should be titrated according to individual needs.

conclusionsBased on the present pharmacokinetic results, no specific dose recommendations are necessary for icodec across age, sex, type of diabetes, race, ethnicity, body weight, serum albumin level and anti-insulin icodec antibody level. CLINICAL

trial registrationClinicalTrials.gov identifiers: NCT03751657, NCT04770532, NCT04795531, NCT04880850 and NCT04848480.

Identifiers

PMID42814374

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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 OpenQuestion graph.