| Trial ID: | L0789 |
| Source ID: | NCT03648554
|
| Associated Drug: |
Dulaglutide
|
| Title: |
A Multicentre Controlled and Randomized Study Assessing the Effect of Dulaglutide add-on to Dietary Reinforcement Versus Dietary Reinforcement Alone in Patients With Type 2 Diabetes and Carriers of a Non-alcoholic Steatohepatitis
|
| Acronym: |
REALIST
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Diabetes Mellitus, Type 2;NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: dulaglutide (TRULICITY??) 1.5 mg;Other: reinforced dietary monitoring
|
| Outcome Measures: |
Responder's proportion difference between the two groups (dulaglutide (TRULICITY??) on top of dietary reinforcement vs. dietary reinforcement alone)Fibrosis Kleiner score;Fibrosis using Fibrotest score;Fibrosis marker parameter;Changes in serum levels of liver enzymes ALT and AST;Changes in Lipid parameters;Improvement in the glycemic control;overall glycemic control improvement;Change in body composition assessed by dual-energy x-ray absorptiometry scans;Change in quality of life;Change in weight;ALT and AST levels;Weight
|
| Sponsor/Collaborators: |
Central Hospital, Nancy, France
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 4
|
| Enrollment: |
93
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
| Start Date: |
27/07/2018
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
France
|
| URL: |
https://clinicaltrials.gov/show/NCT03648554
|
