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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272219
First received: January 6, 2011
Last updated: May 3, 2016
Last verified: May 2016

January 6, 2011
May 3, 2016
June 2011
March 2013   (final data collection date for primary outcome measure)
  • Change From Baseline in Fasting Body Weight [ Time Frame: Week 0, Week 56 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
  • Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. [ Time Frame: At Week 56 ] [ Designated as safety issue: No ]
    Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
  • Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight [ Time Frame: At 56 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
  • Proportion of Subjects With Onset of Type 2 Diabetes [ Time Frame: At 160 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
  • 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 ]
Complete list of historical versions of study NCT01272219 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Waist Circumference (cm) [ Time Frame: Week 0, Week 56 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).
  • Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
  • Pre-diabetes Status After 56 Weeks of Treatment [ Time Frame: Week 0, Week 56 ] [ Designated as safety issue: No ]
    Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).
  • Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
    Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
  • Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
  • Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: At 160 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
  • Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) [ Time Frame: Week 56, Week 68 ] [ Designated as safety issue: No ]
    The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).
  • Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) [ Time Frame: Week 0, Week 68 ] [ Designated as safety issue: No ]
    The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).
  • 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 ]
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
    Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
  • Drug: placebo
    Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
  • Drug: placebo
    Subject with no pre-diabetes at screening, receiving liraglutide placebo subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks, will continue to receive liraglutide placebo for 12 weeks (until week 68).
  • Drug: liraglutide
    Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
  • Drug: placebo
    Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
  • Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
    Intervention: Drug: liraglutide
  • Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
    Intervention: Drug: placebo
  • Placebo Comparator: Liraglutide Placebo, no Pre-diabetes
    Intervention: Drug: placebo
  • Experimental: Liraglutide 3.0mg, Pre-diabetes
    Intervention: Drug: liraglutide
  • Placebo Comparator: Liraglutide Placebo, Pre-diabetes
    Intervention: Drug: placebo
Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3731
March 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT01272219
NN8022-1839, 2008-001049-24, U1111-1118-7871
No
Not Provided
Not Provided
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
May 2016

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