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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00419718
First received: January 8, 2007
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: inhaled human insulin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the plasma insulin profile in the interval [ Time Frame: From 30-150 min after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the plasma insulin profile in the interval from 120-240 min after trial product administration [ Designated as safety issue: No ]
  • Area under the plasma insulin profile in the interval from 240-360 min after trial product administration [ Designated as safety issue: No ]
  • Area under the plasma insulin profile in the interval 0-600 min after trial product administration [ Designated as safety issue: No ]
  • Maximum plasma insulin concentration [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419718

Locations
Austria
Graz, Austria
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Mari-Anne Gall, MD, DMSc Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00419718     History of Changes
Other Study ID Numbers: NN1998-1562
Study First Received: January 8, 2007
Last Updated: July 9, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013