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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02660502 | An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects | PHASE1 | COMPLETED | 15 | — | — | Jan 1, 2016 | May 1, 2016 | May 30, 2016 | 1 | Germany |
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
| Arm | Type | Description |
|---|---|---|
| BioChaperone insulin lispro 0.1 U/kg | EXPERIMENTAL | - |
| BioChaperone insulin lispro 0.2 U/kg | EXPERIMENTAL | - |
| BioChaperone insulin lispro 0.4 U/kg | EXPERIMENTAL | - |
| Humalog® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Biochaperone insulin lispro 0.1 U/kg | DRUG | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg |
| Biochaperone insulin lispro 0.2 U/kg | DRUG | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg |
| Biochaperone insulin lispro 0.4 U/kg | DRUG | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg |
| Humalog® | DRUG | Injection of a single dose of Humalog® at the dose of 0.2 U/kg |
Inclusion Criteria: * Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator. * BMI between 18.5 and 25.0 kg∙m-2, both inclusive. * Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL). * Signed and dat...