Study S000085

A Randomized, Open, Comparative to the Positive-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects Newly Diagnosed as Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT03059719
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: SINGLE
Status: COMPLETED
Enrollment: 36
Start: 2015-04-08
Primary completion: 2016-09-30
Lead sponsor: PegBio Co., Ltd.
Conditions: Type II Diabetes Mellitus
Interventions: BIOLOGICAL:Exenatide injection(Byetta); BIOLOGICAL:PB-119 injection
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Incidence of treatment-emergent AE (safety and tolerability) [the change form base line lab values at 3 months]

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