Type 2 DiabetesPhase 4NCT02055014
Randomisation to Endobarrier Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
A Phase 4 study testing Liraglutide and Duodenal-jejunal bypass liner - Endobarrier device in people with Type 2 Diabetes and Obesity, run by Sandwell & West Birmingham Hospitals NHS Trust at 4 sites in United Kingdom.
Trial summary
New effective non-surgical treatments are needed for patients whose obesity and type 2 diabetes (T2DM) do not respond to current medical therapies. We propose a randomised controlled trial of Endobarrier, an implantable intestinal device that separates ingested food from contacting the first 60cm of intestine where… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity, Diabesity
- What is being tested?
- Liraglutide and Duodenal-jejunal bypass liner - Endobarrier device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2013to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- <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
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- 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)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Department of Diabetes, City Hospital
Birmingham, B18 7QH
Glasgow Royal Infirmary
Glasgow, G0
Department of Diabetes, Guy's and St Thomas' Hospitals
London, SE1
Diabetes Research Group, King's College London
London, SE5 9RS
About this study
Official title: Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
New effective non-surgical treatments are needed for patients whose obesity and type 2 diabetes (T2DM) do not respond to current medical therapies. We propose a randomised controlled trial of Endobarrier, an implantable intestinal device that separates ingested food from contacting the first 60cm of intestine where sited and that mimics some of the clinical effects of bariatric surgery (improved metabolic control with weight loss) with or without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal glycaemic control despite current conventional diabetes treatment, in an NHS setting.
Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous GLP-1RA therapy will be studied over 24 months and randomised to receive Endobarrier with continued Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide 1.8mg without Endobarrier.
Read more
We will investigate potential mechanisms of action and their time course as part of the study by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2. energy intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation and permeability measures.
The data will inform clinical use of the device and development of new treatments for T2DM and obesity.
- Conditions
- Type 2 Diabetes, Obesity, Diabesity
- Being tested
- Liraglutide, Duodenal-jejunal bypass liner - Endobarrier device
- Keywords
- Endobarrier, Duodenal-jejunal bypass liner, Glucagon-like peptide-1 receptor agonist, Liraglutide, Diabesity, Type 2 diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Duodenal-jejunal bypass liner - Endobarrier deviceDevice
Also called EC Certificate Full Quality Assurance System: Certificate US08/5323
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide alone | Active comparator | Liraglutide 1.8mg once daily subcutaneous injection Receives: Drug: Liraglutide |
| Endobarrier alone | Experimental | Duodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy Receives: Device: Duodenal-jejunal bypass liner - Endobarrier device |
| Endobarrier and Liraglutide | Experimental | Duodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection Receives: Drug: Liraglutide; Device: Duodenal-jejunal bypass liner - Endobarrier device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin (HbA1c)
HbA1c (mmol/mol; %) at end of follow-up period compared to baseline. This will be 12 months following Endobarrier device removal which will usually be 24 months after initial the device has first been implanted (for 12 months) or 24 months from Liraglutide 1.8mg initiation.
Measured: 24 months
Secondary outcomes (1)
Weight
Weight (Kg) measured at end of follow-up period compared to baseline. This will be 12 months following Endobarrier device removal which will usually be 24 months after the device has first been implanted (for 12 months) or 24 months from Liraglutide 1.8mg initiation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Association of British Clinical Diabetologists
- Responsible party
- Principal investigator, Dr Bob Ryder, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Bob Ryder, MD FRCP, Principal investigator, Sandwell and West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055014
- Sponsor's protocol ID
- 12DIAB15
- Other IDs
- ISRCTN00151053, 2012-004988-42
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2014
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisation to Endoluminal Intestinal Liner Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
- ClinicalTrials.gov ID
- NCT02055014
- Acronym / sponsor ID
- 12DIAB15
- Conditions
- Type 2 Diabetes, Obesity, Diabesity
- Keywords
- Endobarrier, Duodenal-jejunal bypass liner, Glucagon-like peptide-1 receptor agonist, Liraglutide, Diabesity, Type 2 diabetes, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Association of British Clinical Diabetologists
- Study start
- Jul 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New effective non-surgical treatments are needed for patients whose obesity and type 2 diabetes (T2DM) do not respond to current medical therapies. We propose a randomised controlled trial of Endobarrier, an implantable intestinal device that separates ingested food from contacting the first 60cm of intestine where sited and that mimics some of the clinical effects of bariatric surgery (improved metabolic control with weight loss) with or without continued use of the GLP-1 receptor agonist (GLP-1RA) Liraglutide 1.2mg vs Liraglutide 1.8mg without the device in obese patients with T2DM who remain with suboptimal glycaemic control despite current conventional diabetes treatment, in an NHS setting.
Seventy-two patients with T2DM and obesity (HbA1c≥7.5%, BMI≥35kg/m2) despite previous GLP-1RA therapy will be studied over 24 months and randomised to receive Endobarrier with continued Liraglutide 1.2mg for 12 months; Endobarrier alone for 12 months; or Liraglutide 1.8mg without Endobarrier.
We will investigate potential mechanisms of action and their time course as part of the study by repeated measures of: 1. insulin resistance measures, gut peptides, bile acids; 2. energy intake and nutritional composition; 3. liver fat stores, 4. intestinal inflammation and permeability measures.
The data will inform clinical use of the device and development of new treatments for T2DM and obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liraglutide alone | Active comparator | Drug: LiraglutideLiraglutide 1.8mg once daily subcutaneous injection |
| Endobarrier alone | Experimental | Device: Duodenal-jejunal bypass liner - Endobarrier deviceDuodenal-jejunal bypass liner (Endobarrier) device implantation without additional GLP-1RA therapy |
| Endobarrier and Liraglutide | Experimental | Drug: Liraglutide, Device: Duodenal-jejunal bypass liner - Endobarrier deviceDuodenal-jejunal bypass liner (Endobarrier) device with combined liraglutide 1.2mg once daily subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- <18 years of age
- abnormal intestinal anatomy e.g. Crohn's disease
- contraindication to oesophago-gastroduodenoscopy
- previous bariatric surgery or bowel surgery
- active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Victoza | Drug | Endobarrier and Liraglutide, Liraglutide alone |
| Duodenal-jejunal bypass liner - Endobarrier deviceAlso: EC Certificate Full Quality Assurance System: Certificate US08/5323 | Device | Endobarrier alone, Endobarrier and Liraglutide |
Primary outcome
Glycated haemoglobin (HbA1c)
Time frame: 24 months
HbA1c (mmol/mol; %) at end of follow-up period compared to baseline. This will be 12 months following Endobarrier device removal which will usually be 24 months after initial the device has first been implanted (for 12 months) or 24 months from Liraglutide 1.8mg initiation.
1 secondary outcome
Weight
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bob Ryder, MD FRCP principal investigator
Sandwell and West Birmingham Hospitals NHS Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and Duodenal-jejunal bypass liner - Endobarrier device in people with Type 2 Diabetes and Obesity, run by Sandwell & West Birmingham Hospitals NHS Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated haemoglobin (HbA1c) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.