Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus - Type 2
  • NASH - Nonalcoholic Steatohepatitis
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: open, prospective, randomized, controlled studyMasking: Single (Outcomes Assessor)Masking Description: Only centralized reading by the pathologist of the hepatic histology of the liver puncture biopsy (LPB) will be carried out in blinded procedure.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

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. Co...

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.

Tracking Information

NCT #
NCT03648554
Collaborators
Eli Lilly and Company
Investigators
Principal Investigator: Bruno GUERCI CHRU de Nancy
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