| Trial ID: | L6921 |
| Source ID: | NCT00842361
|
| Associated Drug: |
Insulin Degludec/Insulin Aspart
|
| Title: |
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00842361/results
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin degludec/insulin aspart|DRUG: biphasic insulin aspart 30
|
| Outcome Measures: |
Primary: Rate of Major and Minor Hypoglycaemic Episodes, Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL., Week 0 to Week 6 + 5 days follow up|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes, Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive)., Week 0 to Week 6 + 5 days follow up | Secondary: Number of Treatment Emergent Adverse Events (AEs), Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect., Week 0 to Week 6 + 5 days follow up|Change in Body Weight, Change from baseline in body weight after 6 weeks of treatment, Week 0, Week 6|Electrocardiogram (ECG) Worsening, The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management., Week 0, Week 6|Diastolic BP (Blood Pressure), Values at baseline (Week 0) and at Week 6, Week 0, Week 6|Systolic BP (Blood Pressure), Values at baseline (Week 0) and at Week 6, Week 0, Week 6.
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
66
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01
|
| Completion Date: |
2009-06
|
| Results First Posted: |
2015-11-20
|
| Last Update Posted: |
2017-02-09
|
| Locations: |
Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0002, Japan|Novo Nordisk Investigational Site, Miyazaki-shi, 880 0034, Japan|Novo Nordisk Investigational Site, Naka-shi, Ibaraki, 311 0113, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 144 0035, Japan|Novo Nordisk Investigational Site, Oyama-shi, Tochigi, 323 0022, Japan|Novo Nordisk Investigational Site, Sendai-shi, 980 0021, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, 424 0853, Japan|Novo Nordisk Investigational Site, Tagajo-shi, 985 0852, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00842361
|
