EUCTR2008-007661-24-GB进行中（未招募）1 期
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
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 who is currently treated with metformin alone or metformin + sulfonylurea but who is experiencing inadequate glycemic control. The subject should have received his or her current antidiabetic medication for at least 3 months
- •before Screening and was on a stable dose for at least 8 weeks before randomization.
- •The subject must have a stable dose of =1500 mg metformin for at least 8 weeks before randomization. Subjects with a documented MTD of <1500 mg metformin may also be enrolled if this dose has been stable for 8 weeks before randomization.
- •The subject should not have received >7 contiguous days of any antidiabetic agents other than metformin (or metformin plus a sulfonylurea) within the 3 months before
- •2. BMI =20 kg/m2 and =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]), subjects must be on a stable dose for at least 4 weeks before Screening; however, as necessary during the Run-in 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., increase or decrease 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 the 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, thyroid-binding globulin)
- •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 subjects 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.,
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 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 (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
- •Current or history of heart failure (New York Heart Association class III or IV)
- •Resting systolic pressure is >160 mm Hg and/or diastolic pressure >100 mm Hg. If the subject’s systolic blood pressure >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 average of the systolic or diastolic pressure readings still does 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
- •Mean 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 a fractiona
研究者
相似试验
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 MellitusMedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusType 2 Diabetes MellitusEUCTR2010-019690-15-GBGlaxoSmithKline LLC800
已完成
不适用
A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus-E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11PER-047-09GlaxoSmithKline,
已完成
3 期
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.CTRI/2010/091/001238GlaxoSmithKline800
进行中（未招募）
1 期
A Randomized, Open-label, Parallel Group, Multicenter Pilot Study Evaluating the Efficacy and Safety of Alternative Dosing of Ribavirin vs. Standard of Care Dosing in Combination with Peginterferon alpha-2a in Interferon Naïve Patients with Chronic Hepatitis C Genotype 1 Infection - RibaCChronic hepatitis C infectionMedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis CEUCTR2010-018332-41-DKDept. of Infectious diseases / virology University of Gothenburg105
进行中（未招募）
1 期
A Randomized, Open-label, Parallel Group, Multicenter Pilot Study Evaluating the Efficacy and Safety of Alternative Dosing of Ribavirin vs. Standard of Care Dosing in Combination with Peginterferon alpha-2a in Interferon Naïve Patients with Chronic Hepatitis C Genotype 1 Infection - RibaCChronic hepatitis c genotype 1 treatment naive patients > 18 years of ageEUCTR2010-018332-41-FIHelsinki University Central Hospital35