A Phase 4 interventional study of dulaglutide (TRULICITY®) 1.5 mg and reinforced dietary monitoring in Diabetes Mellitus, Type 2 and NASH - Nonalcoholic Steatohepatitis, sponsored by Central Hospital, Nancy, France. Status unknown at 9 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by Central Hospital, Nancy, France · Phase 4, Interventional, and Treatment
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:
This is a multicentre, open, prospective, randomized, controlled dietary reinforcement study.
All patients are monitored in the same way for dietary reinforcement.
The study will be conducted over the course of 80 weeks in 3 periods (13 visits):
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 93 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Central Hospital, Nancy, France is the lead sponsor of 796 studies on the registry; 187 are open to participants now.
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Person undergone the medical examination adapted to research
Exclusion Criteria:
Person referred in articles L.1121-5, L.1121-7 and L.1121-8 of the Public Health Code:
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.
Drug: dulaglutide (TRULICITY®) 1.5 mg · Other: reinforced dietary monitoring
reinforced dietary monitoring with frequent dietary consultations, based on American Heart Association (AHA) recommendations
Other: reinforced dietary monitoring
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)
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
Time frame: after 52 weeks of treatment
Fibrosis Kleiner score
Mean Changes in Kleiner score of fibrosis with distribution of patients into 3 groups according to the evolution of the score: improvement, stability or worsening.
Time frame: after 52 weeks of treatment
Fibrosis using Fibrotest score
Mean changes in Fibrotest measurement (six markers dosage: ALT, total bilirubin, GGT, Apolipoprotein A1, alpha2-macroglobulin, haptoglobin)
Time frame: after 52 weeks of treatment
Fibrosis marker parameter
Hyaluronic acid serum rate
Time frame: after 52 weeks of treatment
Changes in serum levels of liver enzymes ALT and AST
ALT and AST levels
Time frame: after 52 weeks of treatment
Changes in Lipid parameters
* LDL-cholesterol value * HDL-cholesterol value * Triglycerides value
Time frame: after 52 weeks of treatment
Improvement in the glycemic control
Fasting glucose
Time frame: after 52 weeks of treatment
overall glycemic control improvement
HbA1c
Time frame: after 52 weeks of treatment
Change in body composition assessed by dual-energy x-ray absorptiometry scans
changes in fat mass
Time frame: after 52 weeks of treatment
Change in quality of life
Quality of Life, Obesity and Diet Scale (QOLOD rating scale questionnaire).Items were grouped in 5 dimensions: physical impact, psycho-social impact, sexual impact, comfort with food, diet experience. Each item of the QOLOD questionnaire was graded from 1 to 5 (1: always/enormously; 2: often/a lot; 3: sometimes/moderately; 4: rarely/a little; 5: never/not at all). score was then calculated for each dimension by adding together its constituent items. Scores obtained by adding up answers graded from 1 to 5 of all items per dimension were transformed to convert the lowest and highest score possible to 0 and 100 respectively. Hence the higher the score, the better the quality of life.
Time frame: after 52 weeks of treatment
Change in weight
variation in weight between the beginning and the end of treatment
Time frame: after 52 weeks of treatment
ALT and AST levels
The sustainability of dulaglutide (TRULICITY®) treatment on ALT and AST rates
Time frame: At 24 weeks after completion of the treatment
Weight
The sustainability of dulaglutide (TRULICITY®) treatment on weight
Time frame: At 24 weeks after completion of the treatment
Plan to share: No
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Studies of the drug tested here: Dulaglutide
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