| Trial ID: | L2331 |
| Source ID: | NCT00698126
|
| Associated Drug: |
Soluble Human Insulin
|
| Title: |
Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes
|
| Acronym: |
UPGRADE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: soluble human insulin|DRUG: biphasic insulin aspart
|
| Outcome Measures: |
Primary: Number of major hypoglycaemic events reported as serious adverse drug reactions, after 26 weeks | Secondary: Number of serious and non serious drug reactions, during 26 weeks|Number of serious adverse event, during 26 weeks|Number of all major (daytime and nocturnal) hypoglycaemic events, during 26 weeks|Number of major hypoglycaemic events related to omission of a meal after injection, during 26 weeks|Number of major hypoglycaemic events related to physical exercise of at least 30 min duration, during 26 weeks|Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit, after 26 weeks|Weight and waist circumference change, during 26 weeks|Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level, after 26 weeks|Quality of Life (QoL), after 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
4099
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2007-10
|
| Completion Date: |
2009-05
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-28
|
| Locations: |
Novo Nordisk Investigational Site, Rome, 00144, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00698126
|
