This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
413
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
Lancaster, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
National City, California, United States
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Values for change in HbA1c from baseline to 26 weeks of treatment period.
Time frame: week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Values for change in FPG in mmol/L from baseline to week 26 of randomised period.
Time frame: week 0, week 26
Change From Baseline in Body Weight
Corresponds to the values of change in body weight in kilograms from baseline to week 26.
Time frame: week 0, week 26
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value \< 3.1 mmol/L (56 mg/dL).
Time frame: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.
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Novo Nordisk Investigational Site
Northridge, California, United States
Novo Nordisk Investigational Site
Palm Springs, California, United States
Novo Nordisk Investigational Site
Santa Monica, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Tarzana, California, United States
...and 114 more locations