Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Informed consent obtained
Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds
HbA1c 7.0-10.0% (both inclusive)
Body Mass Index (BMI) at least 27.0 kg/m^2
Stable body weight
Preceding failed dietary effort

Exclusion Criteria

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
Known proliferative retinopathy or maculopathy
History of acute or chronic pancreatitis
Obesity induced by drug treatment
Use of approved weight lowering pharmacotherapy
Previous surgical treatment of obesity
History of major depressive disorder or suicide attempt
Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Screening calcitonin of 50 ng/L or above
Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Personal history of non-familial medullary thyroid carcinoma

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change (%) From Baseline in Body Weight (Fasting)	Week 0, week 56	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.
Proportion of Subjects Losing at Least 5% of Baseline Body Weight	at 56 weeks	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.
Proportion of Subjects Losing More Than 10% of Baseline Body Weight	at 56 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)	Week 0, week 56	Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.
Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%	at 56 weeks
Incidence of Hypoglycaemic Episodes	Weeks 0-56	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 \[56 mg/dL\]).
Proportion of Subjects Reaching Target HbA1c Below 7%	at 56 weeks
Change From Baseline in Waist Circumference	Week 0, week 68
Change (%) From Baseline in Body Weight (Fasting)	Week 0, week 68	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.
Change (%) From Week 56 to 68 in Body Weight (Fasting)	Week 56, week 68	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.
Change From Week 56 to 68 in Waist Circumference	Week 56, week 68