A Randomized, Open-Label, Parallel-Group, Multicenter Studyto Determine the Efficacy and Safety of Albiglutide asCompared With Liraglutide in Subjects With Type 2 DiabetesMellitus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 11
- 主要终点
- Evaluation of change from baseline of HbA1c levels (representing glycemic efficacy) of albiglutide as compared with liraglutide.
研究概览
简要总结
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. Apart from India, other country participating in the study are Germany, Russia, Spain, UK, Israel, South Africa, USA, Brazil, Columbia, Peru, Australia, Philippines, South Korea, Taiwan. The number of subjects planned to be recruited from India is 50 and first subject enrollment was projected 30 Sep 2010. With very narrow gap in DCGI approval and global recruitment closure, no site from India could recruit any subject in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 more than or equal to 20kg per m2 and less than or equal to 45 kg per m2
- •Fasting C-peptide more than or equal to 0.8 ng per mL (more than or equal to 0.26 nmol per L)
- •HbA1c between 7.0 percent and 10.0 percent, 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 Note: Subjects above the age of 65 years will not be enrolled in the study from India, as per Regulatory approval granted by Drugs Controller General of India (DCGI).
结局指标
主要结局
Evaluation of change from baseline of HbA1c levels (representing glycemic efficacy) of albiglutide as compared with liraglutide.
时间窗: Time Frame: 32 weeks from baseline
次要结局
- Change from Baseline in body weight(Time Frame: 32 weeks from baseline)