A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO DETERMINE THE EFFICACY AND SAFETY OF ALBIGLUTIDE AS COMPARED WITH SITAGLIPTIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WITH RENAL IMPAIRMENT

GlaxoSmithKline,0 个研究点目标入组 36 人开始时间: 2010年8月25日最近更新: 2023年9月4日

试验速览

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•1.Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
•2.•BMI >/=20 kg/m2 and 3.•Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
•4.•HbA1c between 7.0% and 10.0%, inclusive.
•Other protocol-defined inclusion criteria apply.

•1.History of cancer
•2.History of treated diabetic gastroparesis
•3.Current biliary disease or history of pancreatitis
•4.History of significant gastrointestinal surgery
•5.Recent clinically significant cardiovascular and/or cerebrovascular disease
•6.History of human immunodeficiency virus infection
•7.Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
•8.Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
•9.Known allergy to any GLP 1 analogue, sitagliptin, other study medications´ excipients, excipients of albiglutide, or Baker´s yeast
•10.Receipt of any investigational drug or sitagliptin 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
•Other protocol-defined exclusion criteria apply.

发起方

GlaxoSmithKline,