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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2005-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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inhaled human insulin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No