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SAR425899

Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 1

Estado

Completado

Participantes

76

previstos

Centros

1

Fin del objetivo primario

ene 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en mar 2015.

Qué mide

Number of adverse events (28 to 35 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To assess in healthy adult male subjects: * The tolerability and safety of 21-day repeated subcutaneous (SC) doses of SAR425899 including two up titration steps. * Pharmacokinetic (PK) parameters of SAR425899 after ascending repeated SC doses in plasma. * Pharmacodynamic (PD) effects on fasting and postprandial plasma glucose, insulin, biomarkers of lipid metabolism and fibroblast growth factor 21 (FGF21). To assess in overweight to obese T2DM mellitus patients: * The tolerability and safety after 28-day repeated SC doses of SAR425899 including 2 up titration steps. * PK parameters of SAR425899 after ascending repeated SC doses in plasma and urine. * PD effects on fasting and postprandial plasma glucose, insulin, C-peptide, incretin panel (total and active ghrelin, total peptide YY \[PYY\], total and active glucagon-like peptide -1 \[GLP-1\], glucagon and total gastric inhibitory polypeptide-1 \[GIP\]), body weight, FGF21, biomarkers of lipid metabolism and HbA1c.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02411825), actualizada en jun 2018.