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

January 23, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma insulin profile in the interval
Time Frame: From 30-150 min after trial product administration
From 30-150 min after trial product administration

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1998-1562

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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