Efecto de liraglutida en el peso corporal en sujetos con sobrepeso u obesos con diabetes tipo 2. Ensayo clínico de 1 año de duración, aleatorizado, doble-ciego, controlado con placebo, con tres grupos paralelos, multicéntrico, multinacional, con un periodo de seguimiento observacional de 12 semanas.
- Conditions
- Obesidad y sobrepesoMedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityMedDRA version: 9.1Level: LLTClassification code 10033307Term: Overweight
- Registration Number
- EUCTR2008-002199-88-ES
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1600
1. Informed consent obtained before any trial-related activities (trial related activities are any procedure that would not have been performed during the normal management of the subject)
2. 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. Treatment should have been stable for at least 3 months prior to screening
3. HbA_1c 7.0-10.0% (both inclusive)
4. Body Mass Index (BMI) = 27.0 kg/m^2
5. Stable body weight (less than 5 kg self-reported change during the previous 3 months)
6. Preceding failed dietary effort
7. Age 18 years and above (or as allowed according to local labelling for metformin and sulphonylurea treatment)
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
Key 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of liraglutide compared to liraglutide placebo in inducing and maintaining weight<br>loss in overweight or obese subjects with type 2 diabetes after 52 weeks<br>;Secondary Objective: To compare liraglutide and liraglutide placebo regarding the effect on:<br>• Parameters of glycaemic control<br>• Waist circumference<br>• Cardiovascular risk factors<br>• Attaining treatment targets of risk factors for subjects with type 2 diabetes<br>• Patient reported outcomes (PRO)<br>• Weight maintenance in the 12-week observational follow-up period<br>;Primary end point(s): Body weight loss (fasting body weight)<br>• Proportion of subjects losing more than 5% of baseline body weight<br>• Proportion of subjects losing more than 10% of baseline body weight<br>
- Secondary Outcome Measures
Name Time Method