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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01334034 | Safety of NNC 0123-0000-0338 in Healthy Subjects | PHASE1 | COMPLETED | 70 | — | — | Apr 11, 2011 | Sep 16, 2011 | Mar 1, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Dose levels 1-7 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC 0123-0000-0338 | DRUG | Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation. |
| placebo | DRUG | Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels. |
| insulin glargine | DRUG | As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels. |
Inclusion Criteria: * Male subject * Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive) Exclusion Criteria: * Known or suspected hypersensitivity to trial products or related products * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartb...