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Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

NCT01272219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3731

Last updated 2018-01-19

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Interventions

DRUG

liraglutide

Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).

DRUG

placebo

Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).

DRUG

liraglutide

Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.

DRUG

placebo

Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry GCR, 1452 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-01
Primary Completion
2013-03-18
Completion
2015-03-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Serbia and Montenegro
  • Serbia
  • South Africa
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01272219 on ClinicalTrials.gov