| Trial ID: | L3503 |
| Source ID: | NCT02055014
|
| Associated Drug: |
Liraglutide
|
| Title: |
Randomisation to Endobarrier Alone Versus With Incretin Analogue in SustainEd Diabesity (REVISE-Diabesity)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Obesity|Diabesity
|
| Interventions: |
DRUG: Liraglutide|DEVICE: Duodenal-jejunal bypass liner - Endobarrier device
|
| Outcome Measures: |
Primary: 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., 24 months | Secondary: 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., 24 months
|
| Sponsor/Collaborators: |
Sponsor: Sandwell & West Birmingham Hospitals NHS Trust | Collaborators: Association of British Clinical Diabetologists
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-07
|
| Completion Date: |
2017-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-26
|
| Locations: |
Department of Diabetes, City Hospital, Birmingham, B18 7QH, United Kingdom|Glasgow Royal Infirmary, Glasgow, G0, United Kingdom|Department of Diabetes, Guy's and St Thomas' Hospitals, London, SE1, United Kingdom|Diabetes Research Group, King's College London, London, SE5 9RS, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02055014
|
