| Trial ID: | L5855 |
| Source ID: | NCT01278160
|
| Associated Drug: |
Biphasic Insulin Aspart 30
|
| Title: |
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01278160/results
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 30|DRUG: metformin
|
| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline, Week 0, week 16 | Secondary: 9-point SMPG (Self Measured Plasma Glucose) Profile, A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day, Week 16|Percentage of Subjects Achieving HbA1c Below 7.0%, The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment, Week 16|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%, The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment, Week 16|Number of Treatment Emergent Hypoglycaemic Episodes, Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included)., Weeks 0-16
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
179
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01
|
| Completion Date: |
2011-09
|
| Results First Posted: |
2012-10-18
|
| Last Update Posted: |
2014-10-27
|
| Locations: |
Beijing, Beijing, 100029, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01278160
|
