This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
401
Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c. Doses individually adjusted.
Insulin aspart added before each main meal. Doses individually adjusted.
Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32
Estimated mean change from baseline in HbA1c after 32 Weeks of treatment
Time frame: Week 0, Week 32
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10
Estimated mean change from baseline in HbA1c after 10 Weeks of treatment
Time frame: Week 0, Week 10
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21
Estimated mean change from baseline in HbA1c after 21 Weeks of treatment
Time frame: Week 0, Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10
Proportion of subjects reaching HbA1c below 7.0% at Week 10
Time frame: Week 10
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21
Proportion of subjects reaching HbA1c below 7.0% at Week 21
Time frame: Week 21
Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32
Proportion of subjects reaching HbA1c below 7.0% at Week 32
Time frame: Week 32
Fasting Plasma Glucose (FPG) at Week 10
Mean FPG at Week 10
Time frame: Week 10
Fasting Plasma Glucose (FPG) at Week 21
Mean FPG at Week 21
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Mesa, Arizona, United States
Novo Nordisk Investigational Site
Scottsdale, Arizona, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Hialeah, Florida, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
Novo Nordisk Investigational Site
Plantation, Florida, United States
...and 57 more locations
Time frame: Week 21
Fasting Plasma Glucose (FPG) at Week 32
Estimated Mean FPG at Week 32
Time frame: Week 32
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10
Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10
Time frame: Week 10
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21
Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21
Time frame: Week 21
Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32
Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32
Time frame: Week 32
Body Weight at Week 32
Estimated mean body weight after 32 Weeks of treatment
Time frame: Week 32
Body Mass Index (BMI) at Week 32
Estimated mean BMI after 32 Weeks of treatment
Time frame: Week 32
Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment.
Time frame: Week 0 to Week 32