A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 to Patients With Type 2 Diabetes Mellitus (T2DM) Not Well-controlled by Metformin Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- The change from baseline value of HbA1c will be compared between treatments
研究概览
简要总结
A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin mono therapy.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses 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 and a 12-week double-blind treatment period.A phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to 1) active drug or placebo at a 3:1 active drug:placebo ratio and 2) exclusion from or inclusion in the pharmacokinetic (PK) blood sample collection subgroup at a 3:1 excluded:included ratio
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom T2DM has been diagnosed according to 2018 American Diabetes Association T2DM diagnostic criteria, have made lifestyle modifications (ie, diet and exercise) for at least 3 months prior to Screening, and have been taking metformin for at least 3 months before Screening with a stable dosage for at least 8 weeks (stable dosage is defined as metformin dosage ≥1500 mg/day or maximum tolerated dose).
- •Males and/or females between the ages of ≥18 and ≤70 years at Screening
- •HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1;
- •FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1;
- •Body mass index (BMI) ≥18.5 and ≤40.0 kg/m2 at Screening, with inclusion of patients with BMIs at the lower end of the range enrolled into the study to enable comparisons across BMI range;
排除标准
- •Medical history or current diagnosis of:
- •Type 1 diabetes mellitus, diabetes caused by pancreas injury or by other diseases (like acromegaly or Cushing syndrome);
- •Diabetes acute complication, like ketoacidosis or hyperosmolar coma;
- •Diagnosed proliferative retinopathy;
- •3 instances of severe hypoglycemia (events during which the patient required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions; episodes may be associated with sufficient neuroglycopenia to have induced seizure or coma) in the 6 months prior to Screening;
- •Significant vascular disease;
- •Current/ongoing diagnosis of any type of malignant tumor or evidence of recurrence in the 6 months prior to Screening (patients who have been stable for ≥6 months or those who have had basal or squamous cell skin cancers removed and have no evidence of recurrence will not be excluded). Patients with a medical history of any other type of cancer in the last 5 years prior to Screening will be excluded;
- •Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack);
研究组 & 干预措施
PB-119 200 μg
PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 100 μg+ Glucophage® (Drug)
PB-119 100 μg
PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 150 μg+ Glucophage® (Drug)
PB-119 100 μg
PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 200 μg+ Glucophage® (Drug)
PB-119 100 μg
PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 placebo + Glucophage® (Drug)
PB-119 150 μg
PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 100 μg+ Glucophage® (Drug)
PB-119 150 μg
PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 200 μg+ Glucophage® (Drug)
PB-119 150 μg
PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 placebo + Glucophage® (Drug)
PB-119 200 μg
PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 150 μg+ Glucophage® (Drug)
PB-119 200 μg
PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 placebo + Glucophage® (Drug)
PB-119 Placebo
PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 100 μg+ Glucophage® (Drug)
PB-119 Placebo
PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 150 μg+ Glucophage® (Drug)
PB-119 Placebo
PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
干预措施: PB-119 200 μg+ Glucophage® (Drug)
结局指标
主要结局
The change from baseline value of HbA1c will be compared between treatments
时间窗: From Baseline to end of treatment (up to Week 12)
次要结局
- The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12(From Baseline to end of treatment (up to Week 12))