Recruitment

Recruitment Status
Completed
Estimated Enrollment
39

Inclusion Criteria

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
Male or female aged 6-64 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 (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
Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

Exclusion Criteria

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)
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

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

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
Male or female aged 6-64 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 (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
Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

Exclusion Criteria

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)
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

Tracking Information

NCT #
NCT02035371
Collaborators
Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S