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

Diabetes Clinical Trial

Official title:

Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419718
• Other study ID #: NN1998-1562
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2007
• Last updated: January 23, 2017
• Start date: October 2005
• Est. completion date: November 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• inhaled human insulin

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Petersen AH, Köhler G, Korsatko S, Wutte A, Wonisch M, Jeppesen OK, Sparre T, Clauson P, Laursen T, Wollmer P, Pieber TR. The effect of exercise on the absorption of inhaled human insulin via the AERx insulin diabetes management system in people with type — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma insulin profile in the interval		From 30-150 min after trial product administration
Secondary	Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
Secondary	Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
Secondary	Area under the plasma insulin profile in the interval 0-600 min after trial product administration
Secondary	Maximum plasma insulin concentration

External Links

•   Clinical Trials at Novo Nordisk