Study S001990

An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT04531176
Acronym: EMPOWER-T2D
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: TERMINATED
Enrollment: 74
Start: 2020-09-01
Primary completion: 2022-08-15
Lead sponsor: The Cleveland Clinic
Conditions: Type 2 Diabetes; Obesity
Interventions: OTHER:Weight Management Program (WMP); OTHER:Traditional care; DRUG:Phentermine / Topiramate Extended Release Oral Capsule; DRUG:naltrexone/bupropion extended-release; DRUG:liraglutide 3.0 mg; DRUG:Orlistat
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Mean Change in Body Weight Between Baseline and 12 Months [12 Months]
Mean Change in A1C [12 Months]

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