A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 841
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
研究概览
简要总结
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
详细描述
This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- •BMI >/=20kg/m2 and </=45 kg/m2
- •Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
- •HbA1c between 7.0% and 10.0%, inclusive
- •Female subjects of childbearing potential must be practicing adequate contraception.
排除标准
- •History of cancer
- •History of treated diabetic gastroparesis
- •Current biliary disease or history of pancreatitis
- •History of significant GI surgery
- •Recent clinically significant cardiovascular and/or cerebrovascular disease
- •Hypertension
- •History of human immunodeficiency virus infection
- •History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
- •History of alcohol or substance abuse
- •Female subject is pregnant, lactating, or <6 weeks postpartum
- •Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
- •History of type 1 diabetes mellitus
- •Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
- •Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
- •History or family history of thyroid disease
研究组 & 干预措施
albiglutide
weekly albiglutide subcutaneous injection
干预措施: albiglutide (Biological)
liraglutide
liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
干预措施: liraglutide (Drug)
结局指标
主要结局
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32
时间窗: Baseline and Week 32
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
次要结局
- Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26(Baseline, Weeks 4, 6, 12, 18 and 26)
- Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32(Week 32)
- Mean Change From Baseline in Body Weight at Week 32(Baseline and Week 32)
- Time to Hyperglycemia Rescue at Week 32(Week 32)
- Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32(Baseline and Week 32)
- Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26(Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26)