Calendario›HALO›Insulin aspart
Insulin aspart
Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)
Ensayo de HALOZYME THERAPEUTICS, INC. en Diabetes tipo 1.
Más ensayos de: Diabetes tipo 1.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 45
- Centros
- 1
- Fin del objetivo primario
- dic 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en ene 2011.
Qué mide
Early Insulin Exposure (%AUC[0-60]), Stage 1 (10 minutes predose up to 60 minutes postdose) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM). This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2. Stage 2 was not initiated due to a strategic business decision and termination was not based on safety or efficacy concerns. No participants were enrolled in Stage 2.
Más ensayos de HALO
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Testosterone enanthate | Fase 3 | Reclutando pacientes | mar 2028 (prevista) |
| PEGPH20 | Fase 1 | Interrumpido | nov 2019 (real) |
| nab-Paclitaxel | Fase 3 | Interrumpido | nov 2019 (real) |
| PEGPH20 | Fase 1 | Completado | mar 2019 (real) |
| PEGPH20 | Fase 2 | Completado | may 2018 (real) |
| PRIMAL | Fase 1 | Interrumpido | ago 2016 (real) |
Todos los de HALO, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01275131), actualizada en jun 2014.