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Insulin glargine · PRESCHOOL

6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

Ensayo de Sanofi en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 3

Estado

Completado

Participantes

125

previstos

Centros

61

Fin del objetivo primario

mar 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2009.

Qué mide

Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) (del registro, en inglés) (6 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: * rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia * HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment * percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment * average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

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Ficha completa en ClinicalTrials.gov (NCT00993473), actualizada en jun 2012.