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REALIST
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
Sponsor study identifier
Secondary identifiers
OTHER · sponsor code
NIH
interventional
93
1 country
9
Study Start
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH. Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group. Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis. Secondary objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 27, 2018
Actual (reported)August 27, 2018
Actual (reported)September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone)
A responder is defined as having a histological improvement defined as the regression of non-alcoholic steatohepatitis (decrease of at least two points in the NASH Activity Score \[NAS\] measured on three components: steatosis, lobular inflammatory foci and hepatocyte ballooning) without worsening of fibrosis (defined by the stage of the Kleiner fibrosis classification) on liver histology obtained by liver puncture biopsy Score \> 4 = NASH confirmed Score 3-4 = borderline Score \< 3 = absence of NASH
after 52 weeks of treatment
Fibrosis Kleiner score
after 52 weeks of treatment
Fibrosis using Fibrotest score
after 52 weeks of treatment
Fibrosis marker parameter
after 52 weeks of treatment
Changes in serum levels of liver enzymes ALT and AST
after 52 weeks of treatment
Changes in Lipid parameters
after 52 weeks of treatment
dulaglutide (TRULICITY®) subcutaneous administration, one weekly injection, in a dose of 1.5 mg of dulaglutide for 52 weeks in combinaison with reinforced dietary monitoring as same as control group.
reinforced dietary monitoring with frequent dietary consultations, based on American Heart Association (AHA) recommendations
dulaglutide (TRULICITY®) 1.5 mg subcutaneous administration, one weekly injection over 52 weeks of treatment
moderate caloric restriction individually adjusted according to the ideal weight and activity level, encouraging regular physical activity (about 30 minutes per day or 150-200 min per week)
CHU de CAEN
Caen, 14033, France
CHU de DIJON
Dijon, 21079, France
Chu Marseille
Marseille, 13915, France
CHRU de MONTPELLIER
Montpellier, 34295, France
Bruno GUERCI
CHRU de Nancy
First Submitted
July 27, 2018
First Posted
August 27, 2018
Study Start
September 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
CHU de REIMS
Reims, 51092, France
CHU de ROUEN
Rouen, 76031, France
CHU de TOULOUSE
Toulouse, 31059, France
CHRU de NANCY
Vandœuvre-lès-Nancy, 54500, France
G.H.M les Portes du Sud
Vénissieux, 69200, France
Primary Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 25, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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