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Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
Plain-language guide to NCT01784965: phase 3 randomized trial of Liraglutide, 69 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01784965
- Phase
- phase 3
- Status
- completed
- Start
- 2009-12
- Completion (planned or actual)
- 2012-12
- Participants
- 69 (actual)
- Design
- randomized, triple-blind, prevention
- Conditions studied
- Pre-diabetes; Older Adults
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Liraglutide.
The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead to greater weight loss than will a calorie-restricted diet alone in subjects who are older (50 to 60 years of age), overweight/obese, and prediabetic.
It had two arms (groups): placebo (placebo comparator) and liraglutide (active comparator).
Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo.
Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo.
The registry classes the interventions as drug.
Who Took Part
69 actual participants took part.
It was open to people of any sex aged from 40 years up to 70 years.
Healthy volunteers could join, not only people with the condition.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.
The Liraglutide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2009-12 with completion listed for 2012-12.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: Change in Weight Reported at 14 Weeks (time frame: Baseline and 14 weeks).
It also tracked 2 secondary outcomes, for example Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H and Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 69 people.
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.