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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01486888 | Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects | PHASE1 | COMPLETED | 45 | — | — | May 1, 2006 | Jul 1, 2006 | Mar 18, 2015 | 1 | Germany |
| NCT01620450 | Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese | PHASE1 | COMPLETED | 34 | — | — | Nov 20, 2004 | Feb 26, 2005 | Mar 1, 2017 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| Formulation A | EXPERIMENTAL | - |
| Formulation B | ACTIVE_COMPARATOR | - |
| NN2000 | EXPERIMENTAL | - |
| NN-X14 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| biphasic human insulin 30 | DRUG | Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits |
Inclusion Criteria: * Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive * Non-smoker, defined as no nicotine consumption for at least one year * Fasting plasma gluco...