| Trial ID: | L4820 |
| Source ID: | NCT01730014
|
| Associated Drug: |
148-0287-A-4.2mm-Cartridge
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Healthy
|
| Interventions: |
DRUG: 148-0287-A-4.2mM-cartridge|DRUG: placebo|DRUG: 148-0287-A-4.2mM-cartridge|DRUG: placebo|DRUG: insulin glargine|DRUG: sodium chloride 0.9% w/v
|
| Outcome Measures: |
Primary: Incidence of adverse events (AE), From trial product administration until completion of the post-treatment follow-up visit at Day 37 | Secondary: Incidence of hypoglycaemic episodes, From trial product administration until completion of the post-treatment follow-up visit at Day 37|AUC, the area under the serum insulin 287 concentration-time curve, From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points|Cmax, the maximum serum insulin 287 concentration, Observed (within 0-36 days)|tmax, the time for maximum serum insulin 287 concentration, Within 0-36 days|Average morning fasting blood glucose (FBG) concentration, From Day 2 to Day 8|Average morning fasting serum C-peptide concentration, From Day 2 to Day 8|Average morning fasting serum free fatty acid (FFA) concentration, From Day 2 to Day 8|Area under the glucose infusion rate (GIR)-time curve, At Day 1-2, 4-5, or 7-8|The maximal GIR (glucose infusion rate) observed, At Day 1-2, 4-5, or 7-8
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-10
|
| Completion Date: |
2013-07
|
| Results First Posted: |
|
| Last Update Posted: |
2013-07-31
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01730014
|
