A RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO DETERMINE THE SAFETY AND EFFICACY OF ALBIGLUTIDE ADMINISTERED IN COMBINATION WITH INSULIN GLARGINE AS COMPARED WITH THE COMBINATION OF INSULIN GLARGINE AND PREPRANDIAL LISPRO INSULIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS

GlaxoSmithKline,0 个研究点目标入组 54 人开始时间: 2010年3月29日最近更新: 2023年9月4日

试验速览

暂无简介。

•1)Male or female, 18 to 75 years of age, with type 2 diabetes, currently treated with insulin glargine or other intermediate- or long-acting insulin, with or without oral antidiabetic medications, but experiencing inadequate glycemic control and willing and capable of participating in a regimen of intensive insulin administration. A subject who has been on an intermediate- or long acting insulin for >/=6 months but <5 years, and, in spite of dosage adjustments based on home blood glucose monitoring, is unable to achieve a HbA1c of <7%.
•2)BMI >/= 20kg/m2 and 3)Fasting C-peptide >/=0.8 ng/mL (>/= 0.26 nmol/L)
•4)HbA1c between 7.0% and 10.5%, inclusive
•5)Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; inhaled, intra articular, and topical corticosteroids are allowed
•6)Hemoglobin >/=11 g/dL for male subjects and >/=10 g/dL for female subjects
•7)Creatinine clearance >60 mL/min (calculated using the Cockcroft Gault formula)
•8)Thyroid stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3, thyroid-binding globulin)
•9)Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study including the 8 week Posttreatment Follow-up Period

•1)History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening.
•2)History of treated diabetic gastroparesis
•3)Current ongoing symptomatic biliary disease or history of pancreatitis
•4)History of significant gastrointestinal surgery, including gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper gastrointestinal function
•5)Recent clinically significant cardiovascular and/or cerebrovascular disease including but not limited to the following:
•Previous history of stroke or transient ischemic attack within 1 month before Screening.
•Acute coronary syndrome, which includes the following:
•-Documented MI within the 2 months before Screening and during the period up until receiving the first dose of study medication
•-Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within the 2 months before Screening and during the period up until receiving the first dose of study medication
•Unstable cardiac rhythm, however, as an example, controlled atrial fibrillation is allowed
•Current or history of heart failure (New York Heart Association class I to IV).
•Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg.

发起方

GlaxoSmithKline,