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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
inhaled human insulin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Area under the plasma insulin profile in the interval

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2007
Last Updated
January 23, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00419718
Brief Title
Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Official Title
Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Primary Outcome Measure Information:
Title
Area under the plasma insulin profile in the interval
Time Frame
From 30-150 min after trial product administration
Secondary Outcome Measure Information:
Title
Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
Title
Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
Title
Area under the plasma insulin profile in the interval 0-600 min after trial product administration
Title
Maximum plasma insulin concentration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
17620446
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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