Type2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM
Verified date | April 2018 |
Source | PegBio Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 15, 2016 |
Est. primary completion date | November 2, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Patients in whom T2DM has been diagnosed for at least 3 months prior to screening and have not been taking any treatment but have made lifestyle modifications (i.e., diet and exercise) for at least 4 weeks or are taking metformin (with no change in the treatment including dose over the past 2 months). 2. In good general health as determined by the investigator at screening evaluation 3. Male and/or female subjects between the ages of 18 and 70 years, inclusive; 4. Are capable of giving informed consent and complying with study procedures; 5. Body Mass Index (BMI) of approximately 22 to 40 kg/m2; 6. Fasting C-peptide test result must be >0.4 nmol/L; 7. HbA1c =6.5 % and =12%; 8. Female subjects must have a negative urine pregnancy test result prior to enrollment. 9. Nonsmoker, 10. Willing and able to adhere to study restrictions and to be confined at the clinical research center. Exclusion Criteria: 1. Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or in subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); 2. Screening fasting blood glucose =100 or =270 mg/dL 3. Type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy; 4. Previous treatment with an approved or investigational GLP-1 mimetic; 5. Patients treated with any investigational drugs within 6 weeks of screening; 6. Subjects with pancreatitis; 7. Clinically significant gastrointestinal disorder 8. History or symptoms of clinically significant cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, 9. Uncontrolled hypertension at screening; 10. History of clinically significant central nervous system disease including: transient ischemic attack, stroke, seizure disorder, depression, 11. History of liver disease 12. History of clinically significant renal disease 13. Uncontrolled severe dyslipidemia; 14. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody; 15. A hospital admission or major surgery within 30 days prior to screening; 16. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening; 17. A history of alcohol abuse according to medical history within 6 months prior to screening; 18. A positive screen for alcohol, or drugs of abuse; 19. An unwillingness or inability to comply with food and beverage restrictions during study participation; 20. Use of prescription or over-the-counter (OTC) medications, and herbal An 21. Unwillingness of male participants to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited |
Country | Name | City | State |
---|---|---|---|
United States | Frontage Clinical Services. Inc. | Hackensack | New Jersey |
United States | Clinical Pharmacology of Miami, Inc. | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
PegBio Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the number of AEs and the finding from the physical examination, the abnormal lab results | include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory) | accessed up to 4 weeks | |
Secondary | PB-119 blood plasma concentration | to collect PB-119 blood plasma concentration of the subjects who use PB-119 intervention | accessed up to 4 weeks | |
Secondary | PB-119 antibody | the number of subjects who are with positive antibody results | accessed up to 4 weeks | |
Secondary | Insulin sensitivity (SI) | be estimated from glucose and insulin concentration | accessed up to 4 weeks | |
Secondary | Beta-cell Responsivity Index | be estimated from serum glucose and c-peptide concentrations | accessed up to 4 weeks | |
Secondary | Disposition Index | be calculated for each individual subject as the product of SI and Ftotal | accessed up to 4 weeks |
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