Patients with type 2 diabetes and carriers of a non-alcoholic steatohepatitis (NASH).
Conditions
Interventions
Trade Name: TRULICITY
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: DULAGLUTIDE
CAS Number: 923950-08-7
Current Sponsor code: DULAGLUTIDE
Other descriptive name: D
Sponsors
CHRU de Nancy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At baseline: • Age > 18 years, =65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
Exclusion criteria: • Patients who received a treatment with a GLP-1 agonist, DPP-4 inhibitors, SGLT2 inhibitors, Thiazolidinediones (TZDs), hepatoprotective drugs such as silymarine (Legalon®) or Ursodeoxycholic acid (Cholurso®, Delursan®, Ursolvan®), vitamin E or Betaine during the six months prior to inclusion (3 months before the reference biopsy) • Patients receiving rapid insulin (human insulin, rapid insulin analogues or premix) in the last 6 months before screening visit • Type 1 Diabetes • Patients with idiopathic hemochromatosis • Patients carriers of hepatitis B or C • Severe or terminal renal impairment (calculated clearance 120,000 and an albumin concentration > 35 g/l can be included) or gastrointestinal bleeding • History of acute or chronic pancreatitis • Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC), or personal history of non-familial medullary thyroid carcinoma • Patients who had bariatric surgery • Patients who received drug treatment for obesity, notably Orlistat, during the last 6 months • Patients with a known allergy or hypersensitivity to the study product or one of its excipients • Any other condition deemed incompatible with the proper conduct of the study as determined by the investigator • Patient having participated in another biomedical research with the taking of an experimental drug within 3 months prior to the screening visit or subject under an exclusion period for other biomedical research. • Woman of childbearing age without effective contraception • Person referred in articles L.1121-5, L.1121-7 and L.1121-8 of the Public Health Code: - Pregnant, parturient or breastfeeding woman - Minor person (non-emancipated) - Adult person under legal protection (any form of public guardianship) - Adult person incapable of giving consent • Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effect of dulaglutide (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 Objective: - After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile and glycemic control. The effect of the treatment will also be assessed on quality of life. - At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.;Primary end point(s): The primary endpoint of the study is the responder’s proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone) after 52 weeks of treatment. A responder is defined as having a decrease of at least two points in the Kleiner score and no worsening of fibrosis on liver histology obtained by liver puncture biopsy. The histological NASH activity score or Kleiner score is measured on three components: steatosis, the necrotic -inflammatory foci and hepatocyte ballooning.;Timepoint(s) of evaluation of this end point: After 52 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on: 1. Fibrosis scores: a. Mean Changes in Fibrosis METAVIR score with distribution of patients into 3 groups according to the evolution of the score: improvement, stability or worsening. b. Mean changes in Fibrotest measurement (six markers dosage: ALT, total bilirubin, GGT, Apolipoprotein A1, alpha 2-macroglobulin, haptoglobin) c. Serum hyaluronic acid 2. Changes in serum levels of liver enzymes ALT and AST 3. Changes in Lipid parameters: a. LDL-cholesterol rate b. HDL-cholesterol rate c. Triglycerides rate 4. Improvement of the glycemic control a. Fasting glucose b. HbA1c 5. Change in body composition assessed by dual-energy x-ray absorptiometry scans. 6. Change in quality of life (Quality of Life, Obesity and Diet Scale - QUOLOD questionnaire) - At 24 weeks after completion of the treatment, assess the sustainability of dulaglutide (TRULICITY®) treatment on ALT and AST rates as well as on weight.;Timepoint(s) of evaluation of this end point: - After 52 weeks of treatment - At 24 weeks after completion of the treatment | — |
Countries
France
Contacts
Public ContactAmandine SEIWERT, chef de projets
CHRU de Nancy
Outcome results
None listed