NCT00522210

Brief Summary

The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 3, 2014

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

August 27, 2007

Last Update Submit

August 29, 2014

Conditions

Type 1 Diabetes

Keywords

type 1 diabeteschildrenlong acting insulin analoguehemoglobin A1c

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C

    6 months

Secondary Outcomes (4)

  • Number of episodes of hypoglycemia (severe and mild)

    6 months

  • Number of episodes of diabetic ketoacidosis (DKA)

    6 months

  • Body Mass Index (BMI) kg/m2

    6 months

  • Diabetes Quality of Life Questionaire-youth version

    6 months

Study Arms (2)

BID insulin with LA analogue

EXPERIMENTAL

Treatment Group: BID Insulin Regimen with Long Acting Insulin Analogue (Detemir)

Drug: Detemir

Standard TID insulin

ACTIVE COMPARATOR

Active Control Group: Usual TID Insulin Regimen (intermediate insulin- Humulin N or Novolin NPH)

Other: Novolin NPH or Humulin N

Interventions

DetemirDRUG

Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time. The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection. The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir. Doses of rapid acting insulin will remain the same at breakfast and at supper.

Also known as: Levemir
BID insulin with LA analogue
Novolin NPH or Humulin NOTHER

Patients will continue on their usual insulin regimen of insulin three times per day. Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.

Standard TID insulin

Eligibility Criteria

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

You may qualify if:

  • Children with DM1 6-17 years old that are currently on a TID regimen of insulin with rapid acting insulin and intermediate acting insulin.
  • Currently being followed at the Alberta Children's Hospital Diabetes Clinic.
  • Duration of diabetes of at least 12 months.

You may not qualify if:

  • Children younger than 6 years of age will be excluded since long-acting analogue has not been approved in children younger than 6 years old.
  • Children with compromised metabolic control (HA1c greater than 10%).
  • Children with other chronic underlying medical conditions that could affect glycemic control i.e. uncontrolled hypothyroidism, hyperthyroidism, celiac disease, etc.
  • Language or psychosocial barrier preventing the family from completing the study.
  • Diabetes duration of less than 12 months.
  • Participation in other clinical trials with specified clinic visit schedule.
  • Patients currently on insulin pump therapy or multiple daily injections of greater than three injections per day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (1)

  • Ho J, Huang C, Nettel-Aguirre A, Pacaud D. Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial. Int J Pediatr Endocrinol. 2011 Nov 8;2011(1):15. doi: 10.1186/1687-9856-2011-15.

    PMID: 22067102RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin DetemirIsophane Insulin, Human

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose 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, IsophaneInsulin, Regular, HumanInsulinProinsulin

Study Officials

  • Josephine Ho, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Endocrinologist

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 29, 2007

Study Start

March 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 3, 2014

Record last verified: 2011-03

Locations

CA(1)