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A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: Faster-acting insulin aspart
Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02033239
U1111-1120-3772 (Other Identifier)
NN1218-3887
2011-001580-41 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.

Enrollment

46 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.5-28.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

46 participants in 2 patient groups

FIAsp
Experimental group
Description:
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
Treatment:
Drug: Faster-acting insulin aspart
NovoRapid®
Active Comparator group
Description:
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
Treatment:
Drug: insulin aspart

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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