| Trial ID: | L4078 |
| Source ID: | NCT02470039
|
| Associated Drug: |
Insulin 338 (Gipet I)
|
| Title: |
Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin 338 (GIPET I)|DRUG: insulin glargine|DRUG: placebo
|
| Outcome Measures: |
Primary: Change in fasting plasma glucose (FPG), Week 0, Week 8 | Secondary: Change from baseline in 10-points plasma glucose profile, Week 0, Week 8|Number of treatment emergent hypoglycaemic episodes, From start of treatment until Visit 14 (Day 68)|area under the serum insulin concentration-time curve, During one dosing interval (0 to 24 hours) at steady state (Day 56)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-06-01
|
| Completion Date: |
2015-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2019-03-18
|
| Locations: |
Novo Nordisk Investigational Site, Mainz, 55116, Germany|Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02470039
|
