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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012317-22-IT
Enrollment
Unknown
Registered
2009-06-26
Start date
2009-12-04
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-puberal children with T1DM MedDRA version: 9.1 Level: LLT Classification code 10023253 MedDRA version: 9.1 Level: LLT Classification code 10021211 MedDRA version: 9.1 Level: LLT Classification code 10045238 MedDRA version: 9.1 Level: LLT Classification code 10045228

Interventions

Trade Name: LEVEMIR Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Insulin detemir Concentration unit: IU international unit(s) Concentration type: equal Concentratio

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: aged >=6 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026