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This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.
This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PB-119 once-weekly-subcutaneous injection | Experimental | PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks. |
|
| Placebo once-weekly-subcutaneous injection | Placebo Comparator | PB-119 150μg matched placebo which will be used in placebo group for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 receptor agonist | Drug | PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline(week 1) to week 25 | week 1, week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Below 7.0% | Percentage of participants with HbA1c below 7.0% was evaluated at week 25. | week 1, week 25 |
| Change in Body Weight (kg) | Change from baseline (week 1) in body weight was evaluated at week 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HuiMin Zhou, MD，PhD | First Hospital of Hebei Medical University | Principal Investigator |
| WeiHong Song, MD，PhD | First People's Hospital of Chenzhou | Principal Investigator |
| YanJun Wang, MD，PhD | Second Hospital of Jilin University | Principal Investigator |
| Jing Yang, MD，PhD | The First Affiliated Hospital of Shanxi Medical University | Principal Investigator |
| Bin Gao, MD，PhD | Tang-Du Hospital | Principal Investigator |
| XinLing Wang, Doctor | People's Hospital of Xinjiang Uygur Autonomous Region | Principal Investigator |
| MingHui Hou, MD，PhD | Affiliated Hospital of Hebei University | Principal Investigator |
| Lin Liao, MD，PhD | Qianfoshan Hospital | Principal Investigator |
| Linong Ji, MD，PhD | Beijing University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks. |
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| week 1, week 25 |
| Change in Fasting Plasma Glucose (FPG) | Change from baseline (week 1) in FPG was evaluated at week 25 | week 1, week 25 |
| Change in Body Mass Index | Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25. | week 1, week 25 |
| Minxiu Yao, MD，PhD | Qingdao Central Hospital | Principal Investigator |
| Huige Shao, MD，PhD | Changsha Central Hospital | Principal Investigator |
| Jingna Lin, MD，PhD | Tianjin People's Hospital | Principal Investigator |
| Xiaohong Lin, MD，PhD | ZhuZhou Central Hospital | Principal Investigator |
| Jianhua Ma, MD，PhD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Wei Zhang, MD，PhD | Qiqihar First Hospital | Principal Investigator |
| Hui Liu, MD，PhD | Luoyang Central Hospital | Principal Investigator |
| Tao Ning, MD，PhD | Baotou Central Hospital | Principal Investigator |
| Xiaohong Wu, MD，PhD | Zhejiang Province People's Hospital | Principal Investigator |
| Xueying Wang, MD，PhD | Jingzhou Central Hospital | Principal Investigator |
| Lan Xu, MD，PhD | WuXi Central Hospital | Principal Investigator |
| D004700 | Endocrine System Diseases |