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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272232

2008-002199-88 (EudraCT Number)

U1111-1118-7963 (Other Identifier)

NN8022-1922

Details and patient eligibility

About

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.

Enrollment: 846 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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846 participants in 3 patient groups

Lira 3.0 mg

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Lira 1.8 mg

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Placebo

Experimental group

Treatment:

Drug: placebo