Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 593
- 主要终点
- Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator
研究概览
简要总结
Primary objective:
The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.
Secondary objectives:
The secondary objectives are to:
- Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator;
- Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator;
- Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator;
- Describe the frequencies of adverse events in the treatment groups; and
- Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 to 75 years of age, inclusive;
- •Body mass index ≤45 kg/m2;
- •Diagnosed with T2DM with HbA1c of ≥7.0% and ≤11.0% and treated with diet and exercise alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and sulfonylurea.
排除标准
- •Currently taking or have taken within the last 6 months non-oral antihyperglycemic agents (eg, insulin, Byetta®, Bydureon®, or Victoza). Short-term use of insulin within this period will not be cause for exclusion if insulin was used during the treatment of an acute intercurrent illness;
- •Known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (GLP-1) receptor analog/agonist;
- •Unstable cardiovascular disease;
- •History of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of GLP-1 receptor agonists;
- •Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have: History, symptoms, or signs of pancreatitis or severe gastrointestinal disease (ie, gastroparesis) or Personal or family history of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type 2;
- •Clinically significant renal and/or hepatic dysfunction;
- •Pregnant or lactating female subjects.
研究组 & 干预措施
Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
干预措施: 50 mg PB1023 (Drug)
Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
干预措施: 70 mg PB1023 (Drug)
Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
干预措施: 100 mg PB1023 (Drug)
Active Comparator
Active Comparator (Victoza) daily SC injection
干预措施: Metformin and Sulfonylurea (Drug)
Sulfonylurea
Sulfonylurea only
干预措施: 70 mg PB1023 (Drug)
Diet and Exercise
Diet and exercise only.
干预措施: 50 mg PB1023 (Drug)
Diet and Exercise
Diet and exercise only.
干预措施: 70 mg PB1023 (Drug)
Sulfonylurea
Sulfonylurea only
干预措施: 100 mg PB1023 (Drug)
Sulfonylurea
Sulfonylurea only
干预措施: Placebo (0.9% Sodium Chloride) (Drug)
Diet and Exercise
Diet and exercise only.
干预措施: 100 mg PB1023 (Drug)
Diet and Exercise
Diet and exercise only.
干预措施: Placebo (0.9% Sodium Chloride) (Drug)
Diet and Exercise
Diet and exercise only.
干预措施: Victoza® (Drug)
Metformin
Metformin only
干预措施: 50 mg PB1023 (Drug)
Metformin
Metformin only
干预措施: 70 mg PB1023 (Drug)
Metformin
Metformin only
干预措施: 100 mg PB1023 (Drug)
Metformin
Metformin only
干预措施: Placebo (0.9% Sodium Chloride) (Drug)
Metformin
Metformin only
干预措施: Victoza® (Drug)
Sulfonylurea
Sulfonylurea only
干预措施: 50 mg PB1023 (Drug)
Sulfonylurea
Sulfonylurea only
干预措施: Victoza® (Drug)
Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
干预措施: Placebo (0.9% Sodium Chloride) (Drug)
Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
干预措施: Victoza® (Drug)
PB1023
PB1023 weekly SC injection
干预措施: 50 mg PB1023 (Drug)
PB1023
PB1023 weekly SC injection
干预措施: 70 mg PB1023 (Drug)
PB1023
PB1023 weekly SC injection
干预措施: 100 mg PB1023 (Drug)
PB1023
PB1023 weekly SC injection
干预措施: Diet and Exercise (Other)
PB1023
PB1023 weekly SC injection
干预措施: Metformin (Drug)
PB1023
PB1023 weekly SC injection
干预措施: Sulfonylurea (Drug)
PB1023
PB1023 weekly SC injection
干预措施: Metformin and Sulfonylurea (Drug)
Active Comparator
Active Comparator (Victoza) daily SC injection
干预措施: Sulfonylurea (Drug)
Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
干预措施: Placebo (0.9% Sodium Chloride) (Drug)
Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
干预措施: Diet and Exercise (Other)
Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
干预措施: Metformin (Drug)
Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
干预措施: Sulfonylurea (Drug)
Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
干预措施: Metformin and Sulfonylurea (Drug)
Active Comparator
Active Comparator (Victoza) daily SC injection
干预措施: Victoza® (Drug)
Active Comparator
Active Comparator (Victoza) daily SC injection
干预措施: Diet and Exercise (Other)
Active Comparator
Active Comparator (Victoza) daily SC injection
干预措施: Metformin (Drug)
结局指标
主要结局
Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator
时间窗: Baseline and 20 weeks
次要结局
- Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator(Up to 23 weeks)
- Describe the frequencies of adverse events in the treatment groups(Up to 23 weeks)
- Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator(Baseline and 20 weeks)
- Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing(Baseline and 20 weeks)