This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
346
Administered s.c. (under the skin) once daily. Dose individually adjusted.
Administered s.c. (under the skin) once daily. Dose individually adjusted.
Administered s.c. (under the skin) once daily. Dose: 1.8 mg.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Change from baseline in HbA1c after 26 weeks of treatment
Time frame: Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment
Time frame: Week 0, week 26
Number of Responders for HbA1c (Below 7.0 %)
Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.
Time frame: After 26 weeks of randomised treatment.
Change From Baseline in Mean Pre-breakfast Measurements Used for Titration
Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
Time frame: Week 0, week 26
Change From Baseline in 8-point Profile
The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
Time frame: Week 0, week 26
Change From Baseline in Mean of the 8-point Profile
Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.
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Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Escondido, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Monterey, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
...and 122 more locations
Time frame: Week 0, week 26
Number of Hypoglycaemic Episodes
Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.
Time frame: Weeks 0 - 26
Number of Adverse Events
Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time frame: Weeks 0 - 26
Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)
Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.
Time frame: Week 0, week 26