drugset / Trial / NCT04074317
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
RandomizedCrossoverOpen-labelTreatment
Summary
This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).
Timeline
- Start
- 2019-08-22
- Primary completion
- 2020-04-02
- Completion
- 2020-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | Subcutaneous |
| Subject | PRAM9 | Unknown | — | Subcutaneous |
| Subject | Pramlintide | Peptide | — | Subcutaneous |