Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Oct 2005
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 8, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedJanuary 24, 2017
January 1, 2017
1 month
January 8, 2007
January 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the plasma insulin profile in the interval
From 30-150 min after trial product administration
Secondary Outcomes (4)
Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
Area under the plasma insulin profile in the interval 0-600 min after trial product administration
Maximum plasma insulin concentration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Graz, 8036, Austria
Related Publications (1)
Petersen AH, Kohler 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 1 diabetes. Diabetes Care. 2007 Oct;30(10):2571-6. doi: 10.2337/dc06-2589. Epub 2007 Jul 9.
PMID: 17620446RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2007
First Posted
January 9, 2007
Study Start
October 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
January 24, 2017
Record last verified: 2017-01