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Clinical Trials/EUCTR2017-002014-31-DE
EUCTR2017-002014-31-DE
Active, not recruiting
Phase 1

A trial comparing the pharmacokinetic properties of fast-acting insulin aspart between children, adolescents and adults with type 1 diabetes

ovo Nordisk A/S0 sites43 target enrollmentOctober 5, 2017
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ConditionsDiabetes Mellitus, Type 1MedDRA version: 20.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsFiasp®NovoRapid®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
ovo Nordisk A/S
Enrollment
43
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 5, 2017
End Date
July 5, 2018
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Male or female aged 6–64 years (both inclusive) at the time of signing informed consent.
  • •\- Diagnosed with type 1 diabetes for 12 months or longer prior to the day of screening.
  • •\- Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28\.0 kg/sqm.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 31
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 16
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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.

Outcomes

Primary Outcomes

Not specified

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