Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.
Interventions
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes more than or equal to 12 months * Baseline HbA1c less than or equal to 11% * Body mass index (BMI) less than or equal to 29 kg/m2 * Normal lung volumes * Treatment with intensified insulin therapy for at least 3 months
Exclusion criteria
* Any present or history of pulmonary disease * Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise * Impaired hepatic or renal function * Cardiac problems * Uncontrolled hypertension * Current proliferative retinopathy or maculopathy * Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator) * Current smoking or smoking within the last 6 months * Blood donation (more than 500 mL) within the last nine weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma insulin profile in the interval | From 30-150 min after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma insulin profile in the interval from 120-240 min after trial product administration | — |
| Area under the plasma insulin profile in the interval from 240-360 min after trial product administration | — |
| Area under the plasma insulin profile in the interval 0-600 min after trial product administration | — |
| Maximum plasma insulin concentration | — |
Countries
Austria
Outcome results
None listed