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: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Drug: liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change (%-points) 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 week 56 to 68 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 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 ]

Enrollment: 846
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272232

  Show 71 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272232     History of Changes
Other Study ID Numbers: NN8022-1922, 2008-002199-88, U1111-1118-7963
Study First Received: January 6, 2011
Last Updated: February 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Overweight
Body Weight
Nutrition Disorders
Malnutrition
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014