Status:
COMPLETED
Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00419718
Start Date
October 1 2005
End Date
November 1 2005
Last Update
January 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Graz, Austria, 8036