Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01272232
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : February 9, 2015
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 7, 2011
Results First Submitted Date  ICMJE January 22, 2015
Results First Posted Date  ICMJE February 9, 2015
Last Update Posted Date December 29, 2017
Actual Study Start Date  ICMJE June 1, 2011
Actual Primary Completion Date January 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • Change (%) From Baseline in Body Weight (Fasting) [ Time Frame: Week 0, week 56 ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
  • Proportion of Subjects Losing at Least 5% of Baseline Body Weight [ Time Frame: at 56 weeks ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
  • Proportion of Subjects Losing More Than 10% of Baseline Body Weight [ Time Frame: at 56 weeks ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
  • Change from baseline in body weight (fasting) [ Time Frame: Week 0, week 56 ]
  • Proportion of Subjects Losing at Least 5% of Baseline Body Weight [ Time Frame: at 56 weeks ]
  • Proportion of Subjects Losing More Than 10% of Baseline Body Weight [ Time Frame: at 56 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
  • Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 0, week 56 ]
    Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.
  • Proportion of Subjects Reaching Target HbA1c Below 7% [ Time Frame: at 56 weeks ]
  • Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% [ Time Frame: at 56 weeks ]
  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 56 ]
  • Change (%) From Baseline in Body Weight (Fasting) [ Time Frame: Week 0, week 68 ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
  • Change (%) From Week 56 to 68 in Body Weight (Fasting) [ Time Frame: Week 56, week 68 ]
    Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 68 ]
  • Change From Week 56 to 68 in Waist Circumference [ Time Frame: Week 56, week 68 ]
  • Incidence of Hypoglycaemic Episodes [ Time Frame: Weeks 0-56 ]
    Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
  • Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0, week 56 ]
  • Proportion of Subjects Reaching Target HbA1c Below 7% [ Time Frame: at 56 weeks ]
  • Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% [ Time Frame: at 56 weeks ]
  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 56 ]
  • Change from baseline in body weight (fasting) [ Time Frame: Week 0, week 68 ]
  • Change from baseline in body weight (fasting) [ Time Frame: Week 56, week 68 ]
  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 68 ]
  • Change in waist circumference [ Time Frame: Week 56, week 68 ]
  • Incidence of Hypoglycaemic Episodes [ Time Frame: Weeks 0-56 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolism and Nutrition Disorder
  • Obesity
Intervention  ICMJE
  • Drug: liraglutide
    Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
  • Drug: liraglutide
    Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
  • Drug: placebo
    Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Study Arms  ICMJE
  • Experimental: Lira 3.0 mg
    Intervention: Drug: liraglutide
  • Experimental: Lira 1.8 mg
    Intervention: Drug: liraglutide
  • Experimental: Placebo
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2013)
846
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2011)
800
Actual Study Completion Date  ICMJE January 25, 2013
Actual Primary Completion Date January 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   India,   Israel,   Italy,   Puerto Rico,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01272232
Other Study ID Numbers  ICMJE NN8022-1922
2008-002199-88 ( EudraCT Number )
U1111-1118-7963 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2017

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