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: 2021年11月24日

试验速览

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•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.

•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).

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