Diabetes Mellitus, Type 2 Clinical Trial
Official 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
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:
- 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, glycemic control and
weight. 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.
This is a multicentre, open, prospective, randomized, controlled dietary reinforcement study.
- Treatment Group: dulaglutide (TRULICITY®) subcutaneous administration, one weekly
injection, in a dose of 1.5 mg of dulaglutide in combinaison with reinforced dietary
monitoring as same as control group.
- Control group: reinforced dietary monitoring with frequent dietary consultations, based
on AHA recommendations:
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):
- Period I: Run-in phase of 4 weeks
- Period II: Treatment phase of 52 weeks
- Period III: Follow-up phase of 24 weeks. The patient must return to the study centre to
assess whether the response to treatment is time-dependent.
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