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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: inhaled human insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00419718

NN1998-1562

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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