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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes

• Registration Number: NCT00419718
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Area under the plasma insulin profile in the interval	From 30-150 min after trial product administration

Secondary Outcome Measures

Name	Time	Method
Area under the plasma insulin profile in the interval 0-600 min after trial product administration
Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
Maximum plasma insulin concentration
Area under the plasma insulin profile in the interval from 240-360 min after trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria