Calendario›LXRX›Sotagliflozin · SOTA-GLIM
Sotagliflozin · SOTA-GLIM
Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
Ensayo de LEXICON PHARMACEUTICALS, INC. en diabetes mellitus tipo 2.
Más ensayos de: Diabetes tipo 2.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 954
- Centros
- 142
- Fin del objetivo primario
- ago 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2017.
Qué mide
Cambio desde el valor inicial en hemoglobina A1c en la semana 52 (inicio y semana 52)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]). * To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. * To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. * To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
Más ensayos de LXRX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Sotagliflozin · SONATA-HCM | Fase 3 | En marcha, sin reclutar | ene 2027 (prevista) |
| LX9211 · PROGRESS | Fase 2 | Completado | ene 2025 (real) |
| LX9211 · RELIEF-PHN1 | Fase 2 | Completado | nov 2022 (real) |
| LX9211 · RELIEF-DPN 1 | Fase 2 | Completado | may 2022 (real) |
| Sotagliflozin · SCORED | Fase 3 | Interrumpido | jul 2020 (real) |
| Sotagliflozin | Fase 3 | Interrumpido | jun 2020 (real) |
Todos los de LXRX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03332771), actualizada en abr 2021.