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NCT04582448

A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes

Completed Phase 1 Last updated 20 January 2023
What this trial tests

Phase 1 trial testing Insulin icodec in Diabetes Mellitus, Type 2 in 25 participants. Completed in 27 September 2021.

Timeline
1 October 2020
Primary endpoint
27 September 2021
27 September 2021

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment25
Start date1 October 2020
Primary completion27 September 2021
Estimated completion27 September 2021
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 69, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions. Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh. The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak. Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus.
    Plum-Mörschel L, Andersen LR, Hansen S, Hövelmann U, et al · · 2023 · cited 20× · PMID 36631720 · DOI 10.1007/s40261-022-01243-6
  2. 58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
    · 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w

Verify or expand the search:

Other trials of Insulin icodec

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Novo Nordisk A/S trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04582448.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing