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Insulin glargine · Lantus-P-CN
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
Ensayo de Sanofi en Diabetes tipo 1.
Más ensayos de: Diabetes tipo 1.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 162
- Centros
- 10
- Fin del objetivo primario
- mar 2014
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2011.
Qué mide
Absolute change of glycosylated hemoglobin (HbA1c) (from baseline to week 24) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: 6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years. Secondary Objectives: * To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on: * Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c \< 7.5%, * Fasting blood glucose (FBG), * Nocturnal blood glucose (BG), * 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values, * Daily total insulin dose and basal insulin dose, * Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia. * To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs). * To assess anti-insulin and anti-glargine antibody development in both groups. * To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing
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Ficha completa en ClinicalTrials.gov (NCT01223131), actualizada en mar 2014.