Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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