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Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Plain-language guide to NCT01179048: phase 3 randomized trial of Liraglutide, 9341 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01179048
- Phase
- phase 3
- Status
- completed
- Start
- 2010-08-31
- Completion (planned or actual)
- 2015-12-17
- Participants
- 9341 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Liraglutide.
This trial is conducted in Africa, Asia, Europe, and North and South America.
The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.
It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
9341 actual participants took part.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
The Liraglutide group and the comparison group ran side by side rather than switching.
As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2010-08-31 with completion listed for 2015-12-17.
It ran at 428 sites in United States (125), Brazil (35), Germany (24), United Kingdom (20), Canada (18) and India (18).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome and Time From Randomisation to First Occurrence of a Composite Microvascular Outcome.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 9341 people.
With 9341 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.