Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/31/2017 |
Start Date: | June 1, 2011 |
End Date: | January 25, 2013 |
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
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.
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.
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
We found this trial at
61
sites
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