Study S000608

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

ClinicalTrials.gov record

Registration

Registration: NCT03648554
Acronym: REALIST
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: SINGLE
Status: UNKNOWN
Enrollment: 93
Start: 2019-09-01
Primary completion: 2023-09-30
Lead sponsor: Central Hospital, Nancy, France
Conditions: Diabetes Mellitus, Type 2; NASH - Nonalcoholic Steatohepatitis
Interventions: DRUG:dulaglutide (TRULICITY®) 1.5 mg; OTHER:reinforced dietary monitoring
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: OTHER:PSS2018/REALIST-GUERCI/AS; NIH:2018

Registered primary outcomes

Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone) [after 52 weeks of treatment]

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