Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes

NCT ID: NCT00567775

Last Updated: 2017-03-01

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

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-21

Study Completion Date

2002-11-20

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.

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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human insulin

Intervention Type DRUG

inhaled human insulin

Intervention Type DRUG

Other Intervention Names

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Actrapid® Novolin® R

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* Treatment for at least 12 months
* HbA1c lesser or equal to 11.0%
* Body weight between 25 and 80 Kg
* Capable to use the device

Exclusion Criteria

* Any diseases other than diabetes requiring prescriptive medication
* Known or suspected allergy to trial product or related products
* Active proliferative retinopathy as judged by the Investigator
* Recurrent severe hypoglycaemia as judged by the Investigator
* The receipt of any investigational drug within 4 weeks prior to this trial
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN1998-1274

Identifier Type: -

Identifier Source: org_study_id

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