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Lixisenatide · GetGoal-Duo1

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 3

Estado

Completado

Participantes

446

previstos

Centros

140

Fin del objetivo primario

ago 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en oct 2009.

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 the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00975286), actualizada en ago 2016.