Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04074317 | Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D | PHASE2 | COMPLETED | 18 | — | — | Aug 22, 2019 | Apr 2, 2020 | Mar 27, 2024 | 1 | United States |
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL \* minutes) for plasma glucose \>180 mg/dL
| Arm | Type | Description |
|---|---|---|
| PRAM9 to Regular Insulin to Regular Insulin+pramlintide | EXPERIMENTAL | Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections |
| Regular Insulin to Regular Insulin+pramlintide to PRAM9 | EXPERIMENTAL | Regular Insulin (Humulin®) to Regular Insulin+pamlintide (Symlin® pen) as separate SC injections to PRAM9 |
| Regular Insulin+pramlintide to PRAM9 to Regular Insulin | EXPERIMENTAL | Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin |
| PRAM9 to Regular Insulin+pramlintide to Regular Insulin | EXPERIMENTAL | Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin |
| Regular Insulin to PRAM9 to Regular Insulin+pramlintide | EXPERIMENTAL | Regular Insulin (Humulin®) to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin |
| Regular Insulin+pramlintide to Regular Insulin to PRAM9 | EXPERIMENTAL | Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin to Xeris pramlintide + insulin co-formulation (PRAM9) |
| Name | Type | Description |
|---|---|---|
| PRAM9 | DRUG | SC injection |
| Regular Insulin + Pramlintide | DRUG | Separate SC injections |
| Regular Insulin | DRUG | SC injection |
Inclusion Criteria: 1. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent 2. Male or non-pregnant, non-lactating female diagnosed with T1D for at least 24 months prior to Scre...