Study S002761

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 in Drug-naïve Subjects With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT03520972
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: TRIPLE
Status: COMPLETED
Enrollment: 251
Start: 2018-06-05
Primary completion: 2019-07-29
Lead sponsor: PegBio Co., Ltd.
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:PB-119 75ug; DRUG:PB-119 150ug; DRUG:PB-119 200ug; DRUG:placebo
Results posted: FALSE

Registered primary outcomes

Change of glycosylated hemoglobin(HbA1c) [12 weeks]

Linked records (3)

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
R0011873	Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Ji L, Diabetologia	2021	Randomized trial	PMID 33687487 DOI	cites ClinicalTrials.gov:NCT03520972; registry reference DERIVED:33687487
R0039753	945-P: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of 12 Once-Weekly Subcutaneous Doses of PB-119 to Patients with Type 2 Diabetes Mellitus as Monotherapy Min Xu, Diabetes	2020	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03520972
R0013400	Emerging PEGylated non-biologic drugs. Park EJ, Expert opinion on emerging drugs	2019	Narrative review	PMID 30957581 DOI	cites ClinicalTrials.gov:NCT03520972; registry reference DERIVED:30957581