Calendario›SNY›Insulin glargine · Soli-CGM

Insulin glargine · Soli-CGM

Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

Ensayo de Sanofi en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 4

Estado

Completado

Participantes

124

previstos

Centros

18

Fin del objetivo primario

mar 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2022.

Qué mide

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)] (Baseline (Days -14 to -1) and Week 16) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs \[OADs\] with or without a glucagon-like peptide 1 receptor agonist \[GLP1 RA\]), as measured by continuous glucose monitoring (CGM). The total study duration per participant was approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts were scheduled. * A screening period of up to 2 weeks * A run-in period of up to 2 weeks, including the baseline period * A 16-week, open-label treatment period * A 2-week post-treatment safety follow-up period

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05114590), actualizada en sep 2025.