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CompletedPhase 1

Clinical Trial for PB-119 in Subjects With Type 2 Diabetes Mellitus

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

Lead sponsor

PegBio Co., Ltd.

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

36

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

Treatment-emergent AEs (any)

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 IDNCT03059719
Org study IDICP-I-2015-01

Timeline

Milestones

Study start2015-04-08actual
Primary completion2016-09-30actual
Study completion2016-10-27actual
Study first posted2017-02-23actual
Last update posted2017-02-23actual

Assets

Investigational agents

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

1. Male and/or female subjects between the ages of 18~45 (inclusive) years, the ratio of females to males is approximately 1:1;

2. Subject has been disguised as type 2 diabetes within 5 years of screening, and met the diagnosis criteria of type 2 diabetes in guidance from WHO and Chinese Diabetes Society (CDS);

3. Subject didn't received any treatment for diabetes before screening, subject has been on diet control for more than 3 months, Fasting Plasma Glucose (FPG) was 7.0 ~ 13.0 mmol / L (including boundary value), and the glycosylated hemoglobin (HbA1c) was 7.0% ~ 10% (Including boundary values);

4. Female weight of ≥45 kg, male weight of ≥50 kg, subject body mass index (BMI) between 19~30 kg/m2 (inclusive);

5. Subject can understand the procedures and methods of this clinical trial, is willing to participate and sign the written informed consent;

Exclusion criteria

1. Subject was diagnosed as type 1 diabetes

2. Subject has acute complications of diabetes, such as ketoacidosis or hyperosmolar coma within 6 months before screening;

3. Subject who is allergic to exenatide, investigational drug or any ingredients (citric acid, mannitol, m-cresol); or have specific severe drug allergy history

4. Patient has specific cardiovascular disease, such as unstable angina pectoris, myocardial infarction, hypertension with poor control using one antihypertensive drugs (mean sitting systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 95mmHg), severe arrhythmia, QTc Prolonged, cardiac dysfunction and so on;

5. Subject who has liver and kidney dysfunction (ALT or AST> 2 times of upper limit of normal reference range, or TBIL> 1.5 times of upper limit of normal reference range, or Cr> upper limit of normal reference range);

6. Subject who's triglyceride≥5mmol/L;

7. Subject who has acute or chronic hepatitis, or other liver disease

8. Known medical history of acute pancreatitis or chronic pancreatitis, or pancreatic amylase> upper limit of normal reference range, or serum lipase> upper limit of normal reference range;

9. Subject has disease which may impact gastric emptying, such as gastroparesis, gastric outlet obstruction, intestinal obstruction, or received gastric bypass surgery, or long-term use of drugs which may have direct impact on gastrointestinal peristalsis;

10. Subject has any clinical significant major disease history or medical history of respiratory system, digestive system, nervous system, hematology system, urology system, immunology, psychiatric system and metabolic disorders etc.

11. Subject has liver, kidney or gastrointestinal partial resection surgery

12. Subject has drug abuse or alcoholic

13. Subject who has received any Chinese and western medication treatment for diabetes;

14. Subject who has taken any prescription or over-the-counter medications (such as orlistat, sibutramine, rimonabant, phenylpropanol or chlorpheniramine) that promote weight loss within 3 months before study;

15. Take any medications that may affect test results, such as antibiotics, non-steroidal anti-inflammatory drugs, antacids containing aluminum or magnesium, diuretics, anticoagulants, central nervous system inhibitors, systemic corticosteroids, medications to slow down the gastrointestinal motility, and any drug that may possibly affect the absorption of the drug within 2 weeks before screening;

16. Participated any clinical trial within 3 months before trial;

17. Female who is pregnant or lactating;

18. Subject who is not able to use contraceptive methods that is medically recognized during study;

19. Subject who cannot complete study due to other reason or determined by investigators as inappropriate to participate this study

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Incidence of treatment-emergent AE (safety and tolerability)

Time frame:the change form base line lab values at 3 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

PB-119 blood concentration

Time frame:hour0, hour12, hour24, hour48, hour72, hour96, hour120, hour144, hour168, hour336, hour504, hour672, hour1344, hour1848, hour1872, hour1896, hour1920, hour2016, hour2112, hour2184 and hour2580

Plasma concentration (steady state)

concentration, descriptive

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.