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 A/S
ClinicalTrials.gov Identifier:
NCT00419718
First received: January 8, 2007
Last updated: July 9, 2012
Last verified: July 2012
  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:


Further study details as provided by Novo Nordisk A/S:

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 A/S
Investigators
Study Director: Mari-Anne Gall, MD, DMSc Novo Nordisk A/S
  More Information

Additional Information:
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 April 17, 2014