| Trial ID: | L1781 |
| Source ID: | NCT01892020
|
| Associated Drug: |
Biphasic Insulin Aspart 50
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| Title: |
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01892020/results
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: biphasic insulin aspart 50|DRUG: biphasic human insulin 50
|
| Outcome Measures: |
Primary: 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test, The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value., After 4 weeks of treatment in each treatment sequence | Secondary: -1-hour PPG Increment Following a Standard Meal Test, The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value., After 4 weeks of treatment in each treatment sequence|-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test, AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model., After 4 weeks of treatment in each treatment sequence|2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile, PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal., After 4 weeks of treatment in each treatment sequence|The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile, Mean post prandial PG increment over all meals was derived as the mean of all available meal increments., After 4 weeks of treatment in each treatment sequence|Incidence of Hypoglycemic Episodes, Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia., During 4 weeks of treatment in each treatment sequence|Incidence of AEs (Adverse Event), Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment., During 4 weeks of treatment in each treatment sequence
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
161
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2014-05
|
| Results First Posted: |
2015-07-09
|
| Last Update Posted: |
2015-07-09
|
| Locations: |
Beijing, Beijing, 100034, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01892020
|
