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NCT03407599

A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes

Completed Phase 1 Last updated 19 June 2019
What this trial tests

Phase 1 trial testing Faster aspart in Diabetes in 46 participants. Completed in 5 July 2018.

Timeline
8 January 2018
Primary endpoint
5 July 2018
5 July 2018

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment46
Start date8 January 2018
Primary completion5 July 2018
Estimated completion5 July 2018
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 6 to 64, any sex, with Diabetes or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 years\]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.

Publications & conference data

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

  1. The association between anti-insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in children and adolescents with type 1 diabetes.
    Biester T, von dem Berge T, Bendtsen LQ, Bendtsen MD, et al · · 2020 · cited 4× · PMID 32306477 · DOI 10.1111/pedi.13026
  2. Effectiveness of Faster Aspart versus Insulin Aspart in Children with Type 1 Diabetes: A Meta-Analysis.
    Wei J, Wang Y. · · 2024 · PMID 38694849 · DOI 10.18502/ijph.v53i1.14680

Verify or expand the search:

Other trials of Faster aspart

Trials testing the same drug.

Other recruiting trials for Diabetes

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/NCT03407599.

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