| Trial ID: | L5183 |
| Source ID: | NCT00699179
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes
|
| Acronym: |
EFFECTIVE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline, After 6 months | Secondary: Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus, after 12 weeks and 26 weeks compared to baseline|Change in FPG (glucose variability), after 12 weeks and 26 weeks compared to baseline|Change in PPG (postprandial control), after 12 weeks and 26 weeks compared to baseline|Change in insulin dose and number of injections, at 12 weeks and 26 weeks of treatment|Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study, after 12 weeks and 26 weeks of treatment compared to baseline|Change in body weight and waist circumference, at 12 weeks and 26 weeks of treatment compared to baseline|Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits, at 12 weeks and 26 weeks of treatment compared to baseline|Number of adverse drug reactions (ADR), after 12 weeks and 26 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
2308
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-06
|
| Completion Date: |
2009-09
|
| Results First Posted: |
|
| Last Update Posted: |
2016-10-31
|
| Locations: |
Novo Nordisk Investigational Site, Belgrade, 11 070, Former Serbia and Montenegro
|
| URL: |
https://clinicaltrials.gov/show/NCT00699179
|
