This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea \[SU\] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
846
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States
Novo Nordisk Investigational Site
Peoria, Arizona, United States
Novo Nordisk Investigational Site
Jonesboro, Arkansas, United States
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Change (%) From Baseline in Body Weight (Fasting)
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time frame: Week 0, week 56
Proportion of Subjects Losing at Least 5% of Baseline Body Weight
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time frame: at 56 weeks
Proportion of Subjects Losing More Than 10% of Baseline Body Weight
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time frame: at 56 weeks
Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)
Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.
Time frame: Week 0, week 56
Proportion of Subjects Reaching Target HbA1c Below 7%
Time frame: at 56 weeks
Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
Time frame: at 56 weeks
Change From Baseline in Waist Circumference
Time frame: Week 0, week 56
Change (%) From Baseline in Body Weight (Fasting)
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time frame: Week 0, week 68
Change (%) From Week 56 to 68 in Body Weight (Fasting)
Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time frame: Week 56, week 68
Change From Baseline in Waist Circumference
Time frame: Week 0, week 68
Change From Week 56 to 68 in Waist Circumference
Time frame: Week 56, week 68
Incidence of Hypoglycaemic Episodes
Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L \[50 mg/dL\] or plasma glucose level below 3.1 mmol/L \[56 mg/dL\]).
Time frame: Weeks 0-56
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Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Mission Hills, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Tustin, California, United States
Novo Nordisk Investigational Site
Arvada, Colorado, United States
...and 151 more locations