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Randomisation to Endobarrier Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
Plain-language guide to NCT02055014: phase 4 randomized trial of Liraglutide, 72 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02055014
- Phase
- phase 4
- Status
- status unknown
- Start
- 2013-07
- Completion (planned or actual)
- 2017-03
- Participants
- 72 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes; Obesity; Diabesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Liraglutide.
It had three arms (groups): Liraglutide alone (active comparator), Endobarrier alone (experimental) and Endobarrier and Liraglutide (experimental).
Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy.
The registry classes the interventions as device and drug.
Who Took Part
Enrollment: 72 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Obesity with latest BMI ≥35 Kg/m2 (≥30 Kg/m2 for those of South Asian origin). Liraglutide therapy for at least 6 months - HbA1c and weight trend data should be available.
The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: \<18 years of age; abnormal intestinal anatomy e.g. crohn's disease; contraindication to oesophago-gastroduodenoscopy.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2013-07 with completion listed for 2017-03.
It ran at 4 sites in United Kingdom (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Glycated haemoglobin (HbA1c) (time frame: 24 months).
It also tracked 1 secondary outcome, for example Weight.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 72 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
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.