Calendario›SNY›Lixisenatide · GETGOAL-M
Lixisenatide · GETGOAL-M
GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
Ensayo de Sanofi en Diabetes tipo 2.
Más ensayos de: Diabetes tipo 2.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 680
- Centros
- 16
- Fin del objetivo primario
- mar 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en jun 2008.
Qué mide
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (del registro, en inglés) (inicio y semana 24)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide as an add-on treatment to metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo, when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction, percentage of patients reaching HbA1c less than (\<) 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), plasma glucose, plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test (only in morning injection arms), body weight, beta-cell function assessed by homeostasis model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development, beta-cell function 4 weeks after study drug discontinuation (only in patients from the morning injection arms in some selected centers).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00712673), actualizada en oct 2016.