Obesity and overweight MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent obtained • Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin+SU, metformin+glitazone, SU+glitazone, metformin+SU+glitazone) • HbA1c 7.0-10.0% (both inclusive) • Body Mass Index (BMI) = 27.0 kg/m2 • Stable body weight • Preceding failed dietary effort Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 = 160 mmHg and/or diastolic blood pressure = 100 mmHg) • Screening calcitonin = 50 ng/L • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of liraglutide compared to liraglutide placebo in inducing and maintaining weight loss in overweight or obese subjects with type 2 diabetes after 56 weeks.;Secondary Objective: To assess and compare the effect of liraglutide versus liraglutide placebo on parameters of glycaemic control, waist circumference, cardiovascular risk factors and patient reported outcomes (PRO) in overweight or obese subjects with type 2 diabetes.;Primary end point(s): • Change from baseline in body weight (fasting body weight) at 56 weeks • Proportion of subjects losing at least 5% of baseline body weight at 56 weeks • Proportion of subjects losing more than 10% of baseline body weight at 56 weeks | — |
Countries
France, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed