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

NCT03059719 | Completed Phase 1

• 1 other identifier: ICP-I-2015-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, opened, positive drug-controlled (Exenatide, Byetta), sequential parallel group, multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of twelve once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM).

Conditions

Type II Diabetes Mellitus

Keywords

safety; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent AE (safety and tolerability)

  N of participants with abnormal lab values and AE relevant to the treatment

  the change form base line lab values at 3 months

Secondary Outcomes (1)

• PB-119 blood concentration

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

Study Arms (2)

PB-119 injection

EXPERIMENTAL

PB119 injection 25ug or 50ug once each week, for three months

Biological: PB-119 injection

Exenatide Injection (Byetta)

ACTIVE COMPARATOR

Byetta 5ug or 10ug twice each day, for three months

Biological: Exenatide injection(Byetta)

Interventions

Exenatide injection(Byetta) BIOLOGICAL

Exenatide Injection (Byetta)

PB-119 injection BIOLOGICAL

PB-119 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female subjects between the ages of 18\~45 (inclusive) years, the ratio of females to males is approximately 1:1;
• 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);
• 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);
• Female weight of ≥45 kg, male weight of ≥50 kg, subject body mass index (BMI) between 19\~30 kg/m2 (inclusive);
• Subject can understand the procedures and methods of this clinical trial, is willing to participate and sign the written informed consent;

You may not qualify if:

• Subject was diagnosed as type 1 diabetes
• Subject has acute complications of diabetes, such as ketoacidosis or hyperosmolar coma within 6 months before screening;
• Subject who is allergic to exenatide, investigational drug or any ingredients (citric acid, mannitol, m-cresol); or have specific severe drug allergy history
• 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;
• 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);
• Subject who's triglyceride≥5mmol/L；
• Subject who has acute or chronic hepatitis, or other liver disease
• 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;
• 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;
• 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.
• Subject has liver, kidney or gastrointestinal partial resection surgery
• Subject has drug abuse or alcoholic
• Subject who has received any Chinese and western medication treatment for diabetes;
• 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;
• 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;

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (1)

No.1 Hospital of Peking University

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yuan Lv

  No.1 Hospital of Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: April 8, 2015
• Primary Completion: September 30, 2016
• Study Completion: October 27, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)