| Trial ID: | L4489 |
| Source ID: | NCT01597713
|
| Associated Drug: |
Nnc 0148-0000-0362
|
| Title: |
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: NNC 0148-0000-0362|DRUG: insulin glargine|DRUG: placebo|DRUG: NNC 0148-0000-0362|DRUG: NNC 0148-0000-0362|DRUG: NNC 0148-0000-0362
|
| Outcome Measures: |
Primary: Number of adverse events, Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit | Secondary: Area under the serum insulin concentration-time curve (with Trial part 1), From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively|Area under the glucose infusion rate (GIR)-time curve (Trial part 1), From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively|Area under the serum insulin concentration-time curve (Trial part 2), From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
83
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-05
|
| Completion Date: |
2012-10
|
| Results First Posted: |
|
| Last Update Posted: |
2015-05-29
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01597713
|
