Calendario›SNY›Glimepiride and Metformin…
Glimepiride and Metformin…
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Ensayo de Sanofi en Diabetes tipo 2.
Más ensayos de: Diabetes tipo 2.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 244
- Centros
- 22
- Fin del objetivo primario
- feb 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2011.
Qué mide
Absolute change in HbA1c (20 weeks, from baseline to week 20) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: * To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives: * To evaluate the percentage of patients reaching HbA1c \< 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. * To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. * To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01457911), actualizada en may 2014.