| Trial ID: | L3286 |
| Source ID: | NCT01215435
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01215435/results
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11, Estimated mean change from baseline in HbA1c after 11 weeks of treatment, Week 0, Week 11 | Secondary: Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36, Estimated mean change from baseline in FPG after 36 weeks of treatment, Week 0, Week 36|Number of Treatment Emergent Hypoglycaemic Episodes, A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product., Week 0 to Week 36
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
245
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-03
|
| Completion Date: |
2012-09
|
| Results First Posted: |
2013-11-25
|
| Last Update Posted: |
2014-10-30
|
| Locations: |
Teheran, Iran, Islamic Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01215435
|
