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Completed

NCT Number: NCT00419718

Effect of Exercise on the Absorption 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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled human insulin

Drug

Primary outcomes

  1. Area under the plasma insulin profile in the interval

    Time frame: From 30-150 min after trial product administration

Secondary outcomes

  1. Area under the plasma insulin profile in the interval from 120-240 min after trial product administration

  2. Area under the plasma insulin profile in the interval from 240-360 min after trial product administration

  3. Area under the plasma insulin profile in the interval 0-600 min after trial product administration

  4. Maximum plasma insulin concentration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jan 9, 2007
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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