Calendario›SNY›Lixisenatide · GETGOAL-MONO
Lixisenatide · GETGOAL-MONO
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)
Ensayo de Sanofi en Diabetes tipo 2.
Más ensayos de: Diabetes tipo 2.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 69
- Centros
- 1
- Fin del objetivo primario
- ene 2011
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en may 2009.
Qué mide
Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring (First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24 weeks of treatment, followed by an extension up to Week 76. The primary objective of this study is to evaluate the safety of lixisenatide once daily treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a 2-step initiation regimen in patients with type 2 diabetes in Japan. The secondary objectives are to assess the overall safety of lixisenatide once daily treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody development.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00905255), actualizada en oct 2016.