NCT00542620

Brief Summary

This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 18, 2013

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

1.5 years

First QC Date

October 10, 2007

Results QC Date

December 5, 2011

Last Update Submit

October 24, 2014

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • Glycosylated Haemoglobin A1c (HbA1c)

    Measured for the Per Protocol (PP) set

    Week 0 and Week 8

  • Glycosylated Haemoglobin A1c (HbA1c)

    Measured for the ITT (Intention-to-Treat) set

    Week 0 and Week 8

Secondary Outcomes (28)

  • Fructosamine

    Week 0 and Week 8

  • Self-measured Plasma Glucose Profile (Before Breakfast)

    Week 0 and Week 8

  • Self-measured Plasma Glucose Profile (After Breakfast)

    Week 0 and Week 8

  • Self-measured Plasma Glucose Profile (Before Dinner)

    Week 0 and Week 8

  • Self-measured Plasma Glucose Profile (After Dinner)

    Week 0 and Week 8

  • +23 more secondary outcomes

Study Arms (2)

Mixed injection

EXPERIMENTAL
Drug: insulin detemirDrug: insulin aspart

Separate injection

ACTIVE COMPARATOR
Drug: insulin detemirDrug: insulin aspart

Interventions

insulin detemirDRUG

Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart

Mixed injection
insulin aspartDRUG

Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir

Mixed injection

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parents' Informed Consent (IC) obtained before any trial-related activities
  • Obtained child's assent (when possible)
  • Type 1 diabetes
  • Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
  • HbA1c (glycosylated haemoglobin A1c) lesser than or equal to 8.6%

You may not qualify if:

  • History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
  • Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
  • Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
  • Any other condition that the Investigator (trial physician) feels would interfere with trial participation or evaluation of results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, France

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin DetemirInsulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 11, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 3, 2014

Results First Posted

January 18, 2013

Record last verified: 2014-10

Locations

FR(1)