PEDIATRIC BASAL BOLUS THERAPY - Basal-Bolus regimen in the treatment of children with type 1 diabetes - PBBT

• Conditions: pre-puberal children with T1DM; MedDRA version: 9.1Level: LLTClassification code 10021211; MedDRA version: 9.1Level: LLTClassification code 10045228; MedDRA version: 9.1Level: LLTClassification code 10045238; MedDRA version: 9.1Level: LLTClassification code 10023253

• Registration Number: EUCTR2009-012317-22-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

aged >=6 and <11 years HbA1c<7,5% basal C-peptide<0,1 nmol/L INFORMED CONSENT signed by parents
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

clinical signs of puberty illness associated with T1DM using any drug except insulin clinical relevant microalbuminuria to non-availability of blood samples

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to study the difference of GH/IGF1 axis in children treated with glargine or detemir;Secondary Objective: to assess metabolic control in a group of pre-puberal children treated with glargine or detemir insulin formulation;Primary end point(s): assess if there are differences of levels of GH and IGF1 in children treated with insulin glargine and detemir in a period of good metabolic control