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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059719
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
PegBio Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Biological: Exenatide injection(Byetta) Biological: PB-119 injection Phase 1

Detailed Description:

There are two study phases according to different doses of investigational drug Phase 1:1 investigational group and 1 control group, i.e.; investigational drug PB-119 injection 25µg group and control drug exenatide group.

Phase 1: Plan to have 1 or 2 investigational group according to the study result from phase 1, i.e., investigational drug PB-119 injection 50 µg group and control drug exenatide group.

Subject Number:18 subjects will be randomized to each group, with equal number of females and males. 12 subjects will be in PB-119 group, 6 subjects will be in exenatide group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 8, 2015
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : October 27, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: PB-119 injection
PB119 injection 25ug or 50ug once each week, for three months
Biological: PB-119 injection
Active Comparator: Exenatide Injection (Byetta)
Byetta 5ug or 10ug twice each day, for three months
Biological: Exenatide injection(Byetta)



Primary Outcome Measures :
  1. Incidence of treatment-emergent AE (safety and tolerability) [ Time Frame: the change form base line lab values at 3 months ]
    N of participants with abnormal lab values and AE relevant to the treatment


Secondary Outcome Measures :
  1. 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 ]
    N of PB-119 blood concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059719


Locations
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China, Beijing
No.1 Hospital of Peking University
Beijing, Beijing, China, 100191
Sponsors and Collaborators
PegBio Co., Ltd.
Investigators
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Principal Investigator: Yuan Lv No.1 Hospital of Peking University
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Responsible Party: PegBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03059719    
Other Study ID Numbers: ICP-I-2015-01
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PegBio Co., Ltd.:
safety
pharmacokinetics
pharmacodynamics
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists