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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 846 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2011
Actual Primary Completion Date : January 1, 2013
Actual Study Completion Date : January 25, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lira 3.0 mg Drug: liraglutide
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Experimental: Lira 1.8 mg Drug: liraglutide
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Experimental: Placebo Drug: placebo
Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. Proportion of Subjects Reaching Target HbA1c Below 7% [ Time Frame: at 56 weeks ]
  3. Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% [ Time Frame: at 56 weeks ]
  4. Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 56 ]
  5. 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.

  6. 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.

  7. Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 68 ]
  8. Change From Week 56 to 68 in Waist Circumference [ Time Frame: Week 56, week 68 ]
  9. 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]).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272232


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272232    
Other Study ID Numbers: NN8022-1922
2008-002199-88 ( EudraCT Number )
U1111-1118-7963 ( Other Identifier: WHO )
First Posted: January 7, 2011    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: December 29, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Overweight
Nutrition Disorders
Body Weight
Overnutrition
Liraglutide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists