GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy

A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone

Lead sponsor

PegBio Co., Ltd.

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

620

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•HbA1c ≤10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04504396

Org study IDPB119302

Timeline

Milestones

Study start2020-06-23actual

Study first posted2020-08-07actual

Primary completion2022-09-15actual

Study completion2023-05-26actual

Last update posted2023-07-28actual

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18~75 years old;

•T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks;

•7.5% ≤ HbA1c ≤ 10.0% at screening;

•18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;

Exclusion criteria

•Any anti-diabetic therapy other than Metformin within 8 weeks before screening；

•T1DM;

•Received insulin therapy more than 14 days within 1 year before screening;

•Female who is pregnant, breast-feeding;

•Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;

•History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；

•History or presence of pancreatitis (acute or chronic);

•Presence or history of malignant neoplasms within the past 5 years prior to the day of screening

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:week 1, week 25

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:week 1, week 25

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in HbA1c

Time frame:week 1, week 25

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Below 7.0%

Time frame:week 1, week 25

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:week 1, week 25

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.