This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
451
Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Time frame: Week 0 to Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
The estimated mean change from baseline in FPG after 26 weeks of treatment.
Time frame: Week 0 to Week 26
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.
Time frame: Week 0 to Week 26
Change in Body Weight From Baseline to Week 26
The estimated mean change in body weight after 26 weeks of treatment.
Time frame: Week 0 to Week 26
Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
Number of subjects achieving HbA1c below 7.0% (American Diabetes Association \[ADA\] target) after 26 weeks of treatment
Time frame: At Week 26
Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists \[AACE\] target) after 26 weeks of treatment.
Time frame: At Week 26
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Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
San Mateo, California, United States
Novo Nordisk Investigational Site
San Ramon, California, United States
Novo Nordisk Investigational Site
Tustin, California, United States
Novo Nordisk Investigational Site
Ventura, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
...and 76 more locations
Number of Adverse Events (AEs) During The Randomised Treatment Period
An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.
Time frame: Week 0 to Week 26 + 7 days follow up
Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period
A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL).
Time frame: Week 0 to Week 26 + 7 days follow up
Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period
Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
Time frame: Week 0 to Week 26 + 7 days follow up