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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272232
First received: January 6, 2011
Last updated: January 22, 2015
Last verified: January 2015

January 6, 2011
January 22, 2015
June 2011
January 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 ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 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 ]
Complete list of historical versions of study NCT01272232 on ClinicalTrials.gov Archive Site
  • Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Change in HbA1c (percentage point) from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]
  • Proportion of Subjects Reaching Target HbA1c Below 7% [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change (%) From Baseline in Body Weight (Fasting) [ Time Frame: Week 0, week 68 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Week 56 to 68 in Waist Circumference [ Time Frame: Week 56, week 68 ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycaemic Episodes [ Time Frame: Weeks 0-56 ] [ Designated as safety issue: No ]
    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]).
  • Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Proportion of subjects reaching target HbA1c below 7% [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects reaching target HbA1c below or equal to 6.5% [ Time Frame: at 56 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight (fasting) [ Time Frame: Week 0, week 68 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight (fasting) [ Time Frame: Week 56, week 68 ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference [ Time Frame: Week 0, week 68 ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: Week 56, week 68 ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Time Frame: Weeks 0-56 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
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

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.

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.
  • 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.
  • Experimental: Lira 3.0 mg
    Intervention: Drug: liraglutide
  • Experimental: Lira 1.8 mg
    Intervention: Drug: liraglutide
  • Experimental: Placebo
    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.
 
Completed
846
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Israel,   Puerto Rico,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom
India
 
NCT01272232
NN8022-1922, 2008-002199-88, U1111-1118-7963
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
January 2015

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