Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss, Endocrine, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/21/2018 |
Start Date: | June 1, 2011 |
End Date: | March 2, 2015 |
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation
This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.
The aim of this clinical trial is to evaluate the potential of liraglutide to induce and
maintain weight loss over 56 weeks in obese subjects or overweight subjects with
co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide
to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.
Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either
68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment
period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects
with pre-diabetes status at baseline).
The aim of this clinical trial is to evaluate the potential of liraglutide to induce and
maintain weight loss over 56 weeks in obese subjects or overweight subjects with
co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide
to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.
Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either
68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment
period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects
with pre-diabetes status at baseline).
Inclusion Criteria:
- Informed consent obtained
- Body Mass Index (BMI) of 30.0 kg/m^2 or above
- Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities of
treated or untreated dyslipidemia and/or hypertension
- Stable body weight
- Preceding failed dietary effort
Exclusion Criteria:
- Known type 1 or type 2 diabetes
- Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126
mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma
glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
- Screening calcitonin of 50 ng/L or above
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- 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 of 160 mmHg or above and/or
diastolic blood pressure of 100 mmHg or above)
We found this trial at
68
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials