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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01486901 | Bioequivalence of Two Insulatard® Formulations in Healthy Subjects | PHASE1 | COMPLETED | 44 | — | — | May 1, 2006 | Jul 1, 2006 | Apr 28, 2015 | 1 | Germany |
| NCT01865279 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec | PHASE1 | COMPLETED | 64 | — | — | Dec 1, 2005 | Apr 1, 2006 | Oct 23, 2015 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Formulation A | EXPERIMENTAL | - |
| Formulation B | ACTIVE_COMPARATOR | - |
| Trial part 1 | EXPERIMENTAL | - |
| Trial part 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| isophane human insulin | DRUG | Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits |
| insulin degludec | DRUG | Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data. |
| placebo | DRUG | Ascending single doses - 5 dose levels |
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...