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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01730014 | A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 70 | — | — | Oct 1, 2012 | Jul 1, 2013 | Jul 31, 2013 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Trial part 1 | EXPERIMENTAL | - |
| Trial part 2, treatment A | EXPERIMENTAL | - |
| Trial part 2, treatment B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 148-0287-A-4.2mM-cartridge | DRUG | In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously. |
| placebo | DRUG | In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously. |
| insulin glargine | DRUG | In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. |
| sodium chloride 0.9% w/v | DRUG | In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B. |
Inclusion Criteria: * TRIAL PART 1 (HEALTHY SUBJECTS): * Healthy male subject * Age 18-55 years (both inclusive) * Body mass index 18.0-28.0 kg/m\^2 (both inclusive) * TRIAL PART 2 (SUBJECTS WITH TYPE 1 DIABETES): * Healthy male subject (with the exception of conditions associated with diabetes mel...