A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PBI-4050 in Type 2 Diabetes Mellitus Patients With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 8
- 主要终点
- To evaluate the safety of PBI-4050 400 mg, 800 mg, and 1200 mg as assessed by the number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
研究概览
简要总结
This is a Phase 2, multi-center, double-blind, placebo-controlled study of the safety and effect of PBI-4050 at doses ranging from 400 mg to 1200 mg on relevant biomarkers in subjects with inadequately-controlled T2DMS on stable background antidiabetic therapy.
详细描述
This Phase 2 study will be performed by 15 sites in Canada. The total duration of study participation for each subject is approximately 20 weeks and comprises 6 study visits
A total of approximately 268 subjects will be enrolled in the study and randomly assigned to one of the following 4 treatment groups:
- PBI-4050 400 mg
- PBI-4050 800 mg
- PBI-4050 1200 mg
- Placebo
All subjects will receive the assigned study drug for 12 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older.
- •Subject has signed written informed consent.
- •Subject has a clinical diagnosis of T2DM with an HbA1c level between ≥ 7.5% and ≤ 10%.
- •Subject has been receiving stable antidiabetic therapy (with or without basal insulin) for a minimum of 3 months before the screening visit.
- •Subject is able and willing to self-monitor blood glucose level at home.
- •Subject has a body mass index (BMI) of ≥ 27 kg/m2 and ≤ 45 kg/m
- •Subject has metabolic syndrome, having at least 3 of the 5 risk factors.
排除标准
- •Subject is using prandial insulin or pre-mixed insulin in addition to oral hypoglycaemic agents for blood glucose control.
- •Subject is taking basal insulin dose > 1.0 U/kg/day.
- •Subject has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.
- •Subject has a history of pancreatitis or diabetic ketoacidosis.
- •Subject has had at least one episode of severe hypoglycaemia in the past 12 months.
- •Subject has evidence of significant cardiovascular disease within 3 months before screening.
- •Subject has an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m
- •Subject has uncontrolled hypertension.
- •Subject has a diagnosis of rheumatic or inflammatory disease; or other autoimmune or inflammatory disease.
- •Subject is concurrently taking and plans to routinely continue taking anti-inflammatory medications during the study.
- •Subject is currently using medications for the indication of (or at the doses indicated for) weight loss.
- •Subject has significantly elevated liver enzyme levels.
- •History of malignancy of any organ system, treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.
- •Subject has a history of chronic alcohol or other substance abuse.
- •Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.
研究组 & 干预措施
Placebo
Daily dose of 6 capsules of placebo
干预措施: Placebo (Other)
PBI-4050 400 mg
Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo
干预措施: PBI-4050 (Drug)
PBI-4050 400 mg
Daily dose of 2 capsules of PBI-4050 and 4 capsules of placebo
干预措施: Placebo (Other)
PBI-4050 800 mg
Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo
干预措施: PBI-4050 (Drug)
PBI-4050 800 mg
Daily dose of 4 capsules of PBI-4050 and 2 capsules of placebo
干预措施: Placebo (Other)
PBI-4050 1200 mg
Daily dose of 6 capsules of PBI-4050
干预措施: PBI-4050 (Drug)
结局指标
主要结局
To evaluate the safety of PBI-4050 400 mg, 800 mg, and 1200 mg as assessed by the number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
时间窗: 4 months
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
To evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg
时间窗: 3 months
Change from baseline on HbA1c levels
次要结局
- Change from baseline on pro-inflammatory/inflammatory biomarkers(3 months)
- Change from baseline on diabetic biomarkers(3 months)
- To evaluate the effect of PBI-4050 on frequency of hypoglycaemia events(3 months)