A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 39
Inclusion Criteria
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m^2
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m^2
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Exclusion Criteria
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- 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
- 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)
Summary
- Conditions
- Diabetes
- Diabetes Mellitus - Type 1
- Diabetes Mellitus, Type 1
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 64 years
- Gender
- Both males and females
Inclusion Criteria
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m^2
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m^2
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Exclusion Criteria
- Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- 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
- 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)
Tracking Information
- NCT #
- NCT02035371
- Collaborators
- Not Provided
- Investigators
- Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
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