| Trial ID: | L1792 |
| Source ID: | NCT01796366
|
| Associated Drug: |
Insulin 338 (Gipet I)
|
| Title: |
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin 338 (GIPET I)|DRUG: placebo|DRUG: insulin glargine|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events, As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit | Secondary: Area under the serum insulin concentration-time curve, During one dosing interval (0-24 hours) at steady-state (Day 10)|Area under the glucose infusion rate-time curve, During one dosing interval (0-24 hours) at steady state (Day 10)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-02-21
|
| Completion Date: |
2013-08-19
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-01
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01796366
|
