Study S002771

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 to Patients With Type 2 Diabetes Mellitus (T2DM) Not Well-controlled by Metformin Monotherapy

ClinicalTrials.gov record

Registration

Registration: NCT03604419
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 214
Start: 2018-06-13
Primary completion: 2019-07-23
Lead sponsor: PegBio Co., Ltd.
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG:PB-119 100 μg+ Glucophage®; DRUG:PB-119 150 μg+ Glucophage®; DRUG:PB-119 200 μg+ Glucophage®; DRUG:PB-119 placebo + Glucophage®
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

The change from baseline value of HbA1c will be compared between treatments [From Baseline to end of treatment (up to Week 12)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0013400	Emerging PEGylated non-biologic drugs. Park EJ, Expert opinion on emerging drugs	2019	Narrative review	PMID 30957581 DOI	cites ClinicalTrials.gov:NCT03604419; registry reference DERIVED:30957581