Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes A 56 week randomised, double-blind, placebo-controlled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - Diabetes

Phase 1

• Conditions: Obesity and overweight; MedDRA version: 14.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2008-002199-88-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-05
• Study Completion: 2013-01-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

• 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

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 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.;<br> Primary end point(s): • Change from baseline in body weight (fasting body weight) at 56 weeks<br> • Proportion of subjects losing at least 5% of baseline body weight at 56 weeks<br> • Proportion of subjects losing more than 10% of baseline body weight at 56 weeks<br>