Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PB-119 once-weekly-subcutaneous injection 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. |
Drug: GLP-1 receptor agonist
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).
|
| Placebo Comparator: Placebo once-weekly-subcutaneous injection PB-119 150μg matched placebo which will be used in placebo group for 24 weeks. |
Drug: Placebo
PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in HbA1c [week 1, week 25]
Change in HbA1c from baseline(week 1) to week 25
Secondary Outcome Measures
- HbA1c Below 7.0% [week 1, week 25]
Percentage of participants with HbA1c below 7.0% was evaluated at week 25.
- Change in Body Weight (kg) [week 1, week 25]
Change from baseline (week 1) in body weight was evaluated at week 25
- Change in Fasting Plasma Glucose (FPG) [week 1, week 25]
Change from baseline (week 1) in FPG was evaluated at week 25
- Change in Body Mass Index [week 1, week 25]
Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, aged 18~75 years old;
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T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,<1500mg) constantly for at least 8 consecutive weeks;
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7.5% ≤ HbA1c ≤ 10.0% at screening;
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18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;
Exclusion Criteria:
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Any anti-diabetic therapy other than Metformin within 8 weeks before screening；
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T1DM;
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Received insulin therapy more than 14 days within 1 year before screening;
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Female who is pregnant, breast-feeding;
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Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;
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History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；
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History or presence of pancreatitis (acute or chronic);
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Presence or history of malignant neoplasms within the past 5 years prior to the day of screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing University People's Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- PegBio Co., Ltd.
Investigators
- Principal Investigator: 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: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PB119302