EUCTR2010-019690-15-GB进行中（未招募）不适用
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1.Male or female, 18 years of age or older, with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- •2.BMI = 20kg/m2 and less than or equal to 45 kg/m2
- •3.Fasting C-peptide =0.8 ng/mL (=0.26 nmol/L)
- •4.HbA1c between 7.0% and 10.0%, inclusive, at Visit 5 (Week –1). The HbA1c value may be checked up to 4 times, and if the average of these determinations meets the criterion, the subject may be randomly assigned to treatment
- •5.For the regular use of other medications (does not include medications excluded by the protocol [see Section 5.6.2 for example, weight loss medications are excluded]), it is preferred that the subjects are receiving a stable dose for at least 4 weeks before Screening; however, as necessary during the Run-in/Stabilization Period and the Treatment Period, prescription or over the counter medications are allowed and may be adjusted by the investigator to optimize treatment (e.g., change in dose of medication to treat blood pressure or hyperlipidemia in accordance with accepted local medical practice and relevant guidance documents)
- •6.Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; however, short courses of oral steroids (single dose or multiple doses for up to 2 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra articular, and topical corticosteroids are allowed
- •7.Hemoglobin =11 g/dL (=110 g/L) for male subjects and =10 g/dL (=100 g/L) for female subjects
- •8.Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula)
- •9.Thyroid stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3)
- •10.Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Methods of adequate contraception include the following: abstinence, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device or intrauterine system, male partner sterilization (vasectomy with documentation of azoospermia) before the female subject’s entry into the study and this male partner is the sole partner for that subject, double barrier method (condom and occlusive cap plus nonoxynol 9), or oral contraceptives in combination with a second method of contraception (e.g., condom and occlusive cap). Adequate contraception must be practiced for the duration of participation in the study including the 8 week Posttreatment Follow-up Period
- •11.Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor
- •12.No major illness or debility that in the investigator’s opinion prohibits the subject from actively participating in their diabetes management and completing the study
- •13.Able and willing to provide written informed consent
- •Subjects eligible for randomization in the study must meet the following additional criteria:
- •HbA1c concentration between 7.0% and 10.0%, inclusive, after the Run in/Stabilization Period (Visit 5, Week –1). If the subject does not qualify for randomization based on this criterion, the assessment may be repeated on a weekly bas
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •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. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed)
- •2.History of treated diabetic gastroparesis
- •3.Current ongoing symptomatic biliary disease or history of pancreatitis
- •4.History of significant GI surgery, including gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function
- •5.Recent (as defined below) 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. However, subjects who are deemed clinically stable by the investigator may be enrolled 1 month after the cerebrovascular event
- •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 angina not responsive to nitroglycerin 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
- •For subjects taking a TZD (e.g., pioglitazone or rosiglitazone), current or history of heart failure (New York Heart Association class I to IV); for subjects not taking a TZD, current or history of heart failure (New York Heart Association class II to IV)
- •Note: Investigators must consult the approved product labeling for TZD in their country to determine a subjects’ eligibility to participate in this study if they are currently taking a TZD
- •Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg. If the subject’s systolic blood pressure is >160 mm Hg or the subject’s diastolic blood pressure is >100 mm Hg at Screening, the blood pressure readings may be repeated at 5-minute intervals for a total of 3 determinations. If the averages of the systolic or diastolic pressure readings still do not meet the criteria, the subject can be treated and rescreened. It is preferred that subjects be on a stable dose of medication for at least 4 weeks before being rescreened; however, when stable, they may be rescreened at the discretion of the investigator
- •Should a subject not meet this criterion on Visit 6 (first dose of study medication following the randomization visit), the subject may continue in the study at the discretion of the investigator with the understanding that the subject’s hypertension will be monitored and treated in accordance with accepted local medical practice and relevant guidance documents
- •QTc interval (Fridericia) >470 ms confirmed by a central reader at Screening
- •6.Hemoglobinopathy that may affect determination of HbA1c
- •7.History of human immunodeficiency virus infection
- •8.History of total bilirubin >1.5 × ULN unless the subject has a previously known history of Gilbert’s syndrome and
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