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 in Drug-naïve Subjects With Type 2 Diabetes Mellitus
概览
- 阶段
- 2 期
- 干预措施
- PB-119 75ug
- 疾病 / 适应症
- Type 2 Diabetes Mellitus
- 发起方
- PegBio Co., Ltd.
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Change of glycosylated hemoglobin(HbA1c)
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
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 in drug-naïve subjects with T2DM.
详细描述
Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. 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 active drug or placebo at a 3:1 active drug:placebo ratio.
研究者
入排标准
入选标准
- •Males and/or females between the ages of ≥18 and ≤70 years at Screening
- •Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
- •HbA1c ≥7.5% and ≤11% at Screening and at Week -1
- •Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening
排除标准
- •Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
- •Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
- •Calcitonin ≥50 ng/L at screening
- •Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
- •Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
- •Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial
- •Blood amylase or lipase \>3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening
- •Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 at Screening
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2x upper limit of normal (ULN) at Screening and pre-randomization
- •Severe cardiovascular diseases occurring within 6 months prior to screening
研究组 & 干预措施
PB-119 75ug
PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks
干预措施: PB-119 75ug
PB-119 150ug
PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks
干预措施: PB-119 150ug
PB-119 200ug
PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks
干预措施: PB-119 200ug
placebo
placebo injection subcutaneously injected once-weekly for 12 weeks
干预措施: placebo
结局指标
主要结局
Change of glycosylated hemoglobin(HbA1c)
时间窗: 12 weeks
Change of HbA1c from baseline value to end of treatment
次要结局
- HbA1c(2, 4, and 8 weeks)
- 2-hour postprandial glucose(2-h PPG)(4, 8, and 12 weeks)
- Insulin(4, 8, and 12 weeks)
- C-peptide(4, 8, and 12 weeks)
- Self-monitoring of blood glucose (SMBG)(4, 8, and 12 weeks)
- Percentage of patients achieving HbA1c ≤6.5%(12 weeks)
- Percentage of patients achieving HbA1c <7%(12 weeks)
- Fasting plasma glucose(FPG)(2, 4, 8, and 12 weeks)