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Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections

NCT00542399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-11-02

No results posted yet for this study

Summary

An open-label, treat to target, intervention study in order to compare the metabolic control of once to twice-daily insulin Detemir injections in children and adolescence with type 1 diabetes mellitus.

All eligible patients will be assigned to receive insulin Detemir once daily before breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The starting dose of insulin Detemir will be individually determined.Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due to hypoglycemic episodes would be switched to treatment consist of twice daily insulin Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but further up titration is possible and patient does not suffer from hypoglycemic episodes, the titration period would be extended and patient would not be switched to treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient will continue until study end on the maintenance phase.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Levemir (insulin detemir)

Levemir once a day

DRUG

Levemir twice a day

Levemir twice a day

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, Professor · Schneider Children Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542399 on ClinicalTrials.gov