A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
研究概览
简要总结
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
详细描述
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication
- •Body mass index (BMI) 17 to 40 kg/ m2 inclusive
- •Subjects with an HbA1c between 7.0% and 10.0% at Screening
- •Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)
排除标准
- •History of type 1 diabetes mellitus
- •Female subject is pregnant, lactating, or <6 weeks postpartum
- •Clinically significant cardiovascular and/or cerebrovascular disease
- •Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
- •Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
- •Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening
研究组 & 干预措施
Albiglutide + Sulfonylurea
Albiglutide in combination with background sulfonylurea
干预措施: Albiglutide (Drug)
Albiglutide + Sulfonylurea
Albiglutide in combination with background sulfonylurea
干预措施: Sulfonylurea (Drug)
Albiglutide + Biguanide
Albiglutide in combination with background biguanide
干预措施: Albiglutide (Drug)
Albiglutide + Biguanide
Albiglutide in combination with background biguanide
干预措施: Biguanide (Drug)
Albiglutide + Glinide
Albiglutide in combination with background glinide
干预措施: Albiglutide (Drug)
Albiglutide + Glinide
Albiglutide in combination with background glinide
干预措施: Glinide (Drug)
Albiglutide + Thiazolidinedione
Albiglutide in combination with background thiazolidinedione
干预措施: Albiglutide (Drug)
Albiglutide + Thiazolidinedione
Albiglutide in combination with background thiazolidinedione
干预措施: Thiazolidinedione (Drug)
Albiglutide + Alpha-glucosidase inhibitor
Albiglutide in combination with background alpha-glucosidase inhibitor
干预措施: Albiglutide (Drug)
Albiglutide + Alpha-glucosidase inhibitor
Albiglutide in combination with background alpha-glucosidase inhibitor
干预措施: Alpha-glucosidase inhibitor (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
时间窗: From Baseline through Week 52
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
Number of Participants With Any Hypoglycemic Event
时间窗: From Baseline through Week 52
Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52(Baseline and Week 52)
- Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)(Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52(Baseline and Week 52)
- Change From Baseline in Body Weight at Week 52(Baseline and Week 52)
- Time to Study Withdrawal Due to Hyperglycemia(Week 52)
