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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01121289 | A Trial Investigating NN1218 in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2010 | Jul 1, 2010 | Dec 10, 2013 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| NN1218, formulation A | EXPERIMENTAL | - |
| NN1218, formulation B | EXPERIMENTAL | - |
| NN1218, formulation B (high) | EXPERIMENTAL | - |
| NN1218, formulation C | EXPERIMENTAL | - |
| NN1218, formulation D | EXPERIMENTAL | - |
| insulin aspart | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NN1218 | DRUG | 0.2 U/kg body weight injected subcutaneously (under the skin) |
| insulin aspart | DRUG | 0.2 U/kg body weight injected subcutaneously (under the skin) |
Inclusion Criteria: * Type 1 diabetes mellitus for more than 12 months * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months * Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive) Exclusion Criteria: * Subject who has...