| Trial ID: | L1934 |
| Source ID: | NCT00842894
|
| Associated Drug: |
Insulin Detemir
|
| Title: |
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin detemir|DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Incidence of serious adverse drug reactions (SADRs), after 26 weeks | Secondary: Number of all minor hypoglycaemic events, during 4 weeks preceding each visit|Number of all major hypoglycaemic events, during 13 weeks preceding each visit|HbA1c, after 26 weeks|Percentage of subjects to reach HbA1c below 7.0%, after 13 weeks and 26 weeks|The effect on glycaemic control as measured by FPG (fasting plasma glucose), after 13 weeks and 26 weeks|The effect on glycamic control as measured by PG profile, after 13 weeks and 26 weeks|Change in body weight, after 13 weeks and 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
3421
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2009-05
|
| Completion Date: |
2010-10
|
| Results First Posted: |
|
| Last Update Posted: |
2014-08-15
|
| Locations: |
Skopje, MK-1000, Macedonia, The Former Yugoslav Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00842894
|
