Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272219
First received: January 6, 2011
Last updated: August 5, 2014
Last verified: August 2014

January 6, 2011
August 5, 2014
June 2011
March 2013   (final data collection date for primary outcome measure)
  • Change from baseline in body weight (fasting) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Proportion of subjects losing at least 5% of baseline body weight [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects losing more than 10% of baseline body weight [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with onset of type 2 diabetes [ Time Frame: at 160 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01272219 on ClinicalTrials.gov Archive Site
  • Change from baseline in waist circumference [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference (subjects with pre-diabetes at baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
  • Change from baseline in pre-diabetes status [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change from baseline in pre-diabetes status (subjects with pre-diabetes at baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
  • Mean change from baseline in body weight (subjects with pre-diabetes at baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
  • Proportion of subjects losing at least 5% and more than 10% of baseline body weight (subjects with pre-diabetes at baseline) [ Time Frame: at 160 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes) [ Time Frame: Week 56, week 68 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes) [ Time Frame: Week 0, week 68 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Metabolism and Nutrition Disorder
  • Obesity
  • Drug: liraglutide
    Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks. After 56 weeks, subjects will be re-randomised to receive either liraglutide or liraglutide placebo for 12 weeks
  • Drug: placebo
    Liraglutide placebo 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks
  • Drug: liraglutide
    Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 160 weeks
  • Drug: placebo
    Liraglutide placebo 3.0 mg for subcutaneous (under the skin) injection once daily for 160 weeks
  • Experimental: Liraglutide, no pre-diabetes
    Intervention: Drug: liraglutide
  • Placebo Comparator: Liraglutide placebo, no pre-diabetes
    Intervention: Drug: placebo
  • Experimental: Liraglutide, pre-diabetes
    Intervention: Drug: liraglutide
  • Placebo Comparator: Liraglutide placebo, pre-diabetes
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3733
February 2015
March 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Switzerland,   Spain,   South Africa,   Serbia,   Russian Federation,   Poland,   Turkey,   Netherlands,   Mexico,   Italy,   Israel,   Ireland,   India,   Hungary,   Hong Kong,   Germany,   France,   Finland,   Denmark,   Canada,   Brazil,   Belgium,   Austria,   Australia,   Norway,   United States
 
NCT01272219
NN8022-1839, 2008-001049-24, U1111-1118-7871
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP