CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 846 enrolled
Drug / intervention
liraglutide +2 moredrug
Likely dose
liraglutide 3.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01272232
NCT01272232Phase 3Completed
CompareCT.gov

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

Novo Nordisk A/S·interventional·Posted Jan 7, 2011·Updated Dec 29, 2017

In Brief

A Phase 3 clinical trial evaluating liraglutide and placebo for Metabolism and Nutrition Disorder and Obesity. Completed, enrolled 846 participants across 161 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolism and Nutrition Disorder, Obesity
CountriesFrance, Germany, India, Israel, Italy, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2013
Study CompletionJan 25, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.5 years ago

Interventions

liraglutidedrug

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

liraglutidedrug

Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

placebodrug

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