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Alogliptin · ACADEMIC

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

1.293

previstos

Centros

1

Fin del objetivo primario

dic 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2019.

Qué mide

Change in Hemoglobin A1c (del registro, en inglés) (del inicio a la semana 16)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: * To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs. * To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for Alogliptin compared with acarbose during the whole treatment period. Secondary Objectives: * To assess efficacy in terms of the percentage of patients achieving HbA1c\<7%. * To assess efficacy in terms of percentage of patients achieving HbA1c\<7% without GI effects. * To assess change from baseline in Fasting plasma glucose (FPG), 2-h Post plasma glucose (2-h PPG), β-cell function (HOMA-β), lipids and body weight. * To assess safety in terms of occurrence of hypoglycemia events. * To assess safety in terms of other adverse events. * To assess patient adherence and tolerability.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03794336), actualizada en abr 2022.