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UnknownPhase 4

Randomisation to Endobarrier Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)

Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

4

Recruiting sites

Enrollment

72

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥35HbA1c ≥7.5%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02055014
Org study ID12DIAB15
Secondary ID2012-004988-42
Secondary IDISRCTN00151053ISRCTN

Timeline

Milestones

Study first posted2014-02-04estimated
Last update posted2016-04-26estimated
Study start2013-07 (month precision)
Primary completion2017-03estimated (month precision)
Study completion2017-03estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

type 2 diabetes with latest HbA1c ≥7.5% (≥58mmol/mol)
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
stable weight and HbA1c in preceding 3 months (<3 Kg reduction in weight and <0.3% reduction in HbA1c)

Exclusion criteria

<18 years of age
abnormal intestinal anatomy e.g. Crohn's disease
contraindication to oesophago-gastroduodenoscopy
previous bariatric surgery or bowel surgery
active infection
anticoagulation therapy which cannot be discontinued/ coagulopathy INR >1.3
eGFR <30
known portal hypertension
previous pancreatitis or amylase > 3 times the upper limit of normal
uncontrolled cardiovascular disease
lactating or pregnant females
patients taking aspirin in whom it should continue (e.g. active ischaemic heart disease or cerebrovascular disease)
excess anaesthetic risk as identified by the anaesthetist or investigator (e.g. uncontrolled obstructive sleep apnoea)

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight

Time frame:24 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Glycated haemoglobin (HbA1c)

Time frame:24 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.