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NCT03723759

A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus

Completed Phase 1 Last updated 18 March 2020
What this trial tests

Phase 1 trial testing Faster Aspart 200 U/mL in Diabetes Mellitus, Type 1 in 56 participants. Completed in 27 March 2019.

Timeline
26 October 2018
Primary endpoint
21 March 2019
27 March 2019

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment56
Start date26 October 2018
Primary completion21 March 2019
Estimated completion27 March 2019
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 64, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

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/NCT03723759.

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