Skip to main content
OpenTrials
Completed

NCT Number: NCT01272232

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Bondy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Placebo

Drug

Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Primary outcomes

  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 outcomes

  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]).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2011
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.