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临床试验/CTRI/2010/091/001238
CTRI/2010/091/001238已完成3 期

A Randomized, Open-Label, Parallel-Group, Multicenter Studyto Determine the Efficacy and Safety of Albiglutide asCompared With Liraglutide in Subjects With Type 2 DiabetesMellitus.

GlaxoSmithKline0 个研究点目标入组 800 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
800

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. 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
  • 2. BMI more than or equal to 20kg per m2 and less than or equal to 45 kg per m2
  • 3. Fasting C-peptide more than or equal to 0.8 ng per mL (more than or equal to 0.26 nmol per L)
  • 4. HbA1c between 7.0 percent and 10.0 percent, inclusive
  • 5. Female subjects of childbearing potential must be practicing adequate contraception.

排除标准

  • 1. History of cancer
  • 2. History of treated diabetic gastroparesis
  • 3. Current biliary disease or history of pancreatitis
  • 4. History of significant GI surgery
  • 5. Recent clinically significant cardiovascular and/or cerebrovascular disease
  • 6. Hypertension
  • 7. History of human immunodeficiency virus infection
  • 8. History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
  • 9. History of alcohol or substance abuse
  • 10. Female subject is pregnant, lactating, or <6 weeks postpartum
  • 11. Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
  • 12. 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)
  • 13. 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
  • 14. 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).

研究者