NCT00567775

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

November 30, 2007

Last Update Submit

February 28, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the serum insulin curve

    from 0 to 5 hours post-dosing

Secondary Outcomes (2)

  • Maximum serum insulin concentration

    in the interval from 0 to 5 hours post-dosing

  • Time to maximum serum insulin concentration

    in the interval from 0 to 5 hours post-dosing

Interventions

human insulinDRUG
Also known as: Actrapid®, Novolin® R
inhaled human insulinDRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 5, 2007

Study Start

October 21, 2002

Primary Completion

November 20, 2002

Study Completion

November 20, 2002

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

DK(1)