Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6778
Source ID: NCT00627445
Associated Drug: Biphasic Insulin Aspart 30
Title: Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00627445/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart 30|DRUG: metformin|DRUG: biphasic insulin aspart 50
Outcome Measures: Primary: Change in Glycosylated Haemoglobin A1c (HbA1c), Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16), week 0, week 16 | Secondary: The Percentage of Subjects Achieving HbA1c Treatment Targets, The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%., week 16|Change and Daily Average in 8-point Plasma Glucose, Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment., week 0, week 16|Change and Daily Average in Prandial Plasma Glucose Increment, Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment., week 0, week 16|The Total Increase in Total Daily Insulin Dose Per Body Weight, The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16)., week 0, week 16|Change in Body Weight, Change in body weight from baseline (week 0) to end of treatment (week 16), week 0, week 16|Number of Hypoglycaemic Episodes, Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL., weeks 0-16|Number of Nocturnal Hypoglycaemic Episodes, Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL., weeks 0-16
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 441
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-02
Completion Date: 2009-01
Results First Posted: 2010-03-31
Last Update Posted: 2014-10-22
Locations: Beijing, Beijing, 100034, China
URL: https://clinicaltrials.gov/show/NCT00627445