| Trial ID: | L5347 |
| Source ID: | NCT01649570
|
| Associated Drug: |
Insulin Aspart
|
| Title: |
Safety and Efficacy of Insulin Aspart in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin aspart
|
| Outcome Measures: |
Primary: Incidence of hypoglycaemia | Secondary: Incidence of adverse events (AEs)|Clinical laboratory tests: Haematology and biochemistry|Insulin antibodies|Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
123
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-03
|
| Completion Date: |
2003-08
|
| Results First Posted: |
|
| Last Update Posted: |
2012-07-25
|
| Locations: |
Tokyo, 103, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01649570
|
