EUCTR2011-002104-32-DE
Active, not recruiting
Not Applicable
A trial investigating the pharmacokinetic properties of FIAsp in children, adolescents and adults with type 1 diabetes
ConditionsDiabetes Mellitus, Type 1MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsNovoRapid
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- ovo Nordisk A/S
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female aged 6–64 years (both inclusive) at the time of signing informed consent.
- •2\. Type 1 diabetes mellitus (as diagnosed clinically) \= 12 months.
- •3\. Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults \= 28\.0 kg/m^2\.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 13
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening.
- •2\. Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily).
- •3\. 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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