Study S001583

An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide

ClinicalTrials.gov record

Registration

Registration: NCT02638805
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 136
Start: 2015-12
Primary completion: 2017-10
Lead sponsor: Intarcia Therapeutics
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:ITCA 650 Osmotic Mini Pump 20/60 mcg/day; DRUG:ITCA 650 Osmotic Mini Pump 60 mcg/day; DRUG:Metformin; DRUG:Liraglutide
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting [From Randomization to 34 weeks]

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