PER-047-09已完成未知
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
GlaxoSmithKline,0 个研究点目标入组 0 人开始时间: 2009年9月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Men or women, 18 years of age or older, with a previous diagnosis of type 2 diabetes mellitus currently treated with metformin alone or with metformin + sulfonylurea, but who show insufficient glycemic control. The subject must have received their current antidiabetic medication for at least 3 months before selection and be taking a stable dose from at least 8 weeks before randomization. The subject must have maintained a stable dose of IR metformin> or = 1500 mg for at least 8 weeks before randomization. Subjects receiving a documented DMT <1,500 mg of IR metformin may also be recruited as long as this dose has been stable for 8 weeks before randomization. The subject must not have received any antidiabetic, apart from metformin, for more than seven consecutive days in the three months prior to the selection.
- •BMI> or = 20 and • Fasting peptide C> or = 0.8 ng / ml (> or = 0.26 nmol / l).
- •HbA1c between 7.0% and 10.0%, both inclusive.
- •In case of regular use of other drugs not excluded, the dose must have been stable for at least four weeks prior to selection. However, on-demand use of prescription or over-the-counter medications at the discretion of the investigator will be allowed.
- •The use of oral or systemically injected glucocorticoids during the three months prior to randomization will not be allowed. The use of inhaled, intra-articular and topical corticosteroids will be allowed.
- •Hemoglobin> or = 11 g / dl (> or = 110 g / l) in men and> or = 10 g / dl (> or = 100 g / l) in women.
- •Creatinine clearance> 60 ml / min (calculated with the Cockcroft-Gault formula).
- •Normal thyrotropin concentration or clinical euthyroidism according to the investigator´s criteria.
- •Women of childbearing age (ie, who are not surgically sterile or postmenopausal) should be using appropriate contraceptive methods. Suitable contraceptive methods are: abstinence, injectable progestogen, levonorgestrel implants, estrogen vaginal ring, percutaneous contraceptive patches, intrauterine device or system, sterilization of the male partner (vasectomy with azoospermia documentation) before a woman enters the study, said male partner being that woman´s only partner, double barrier method (condom or occlusive cap plus nonoxynol-9) or oral contraceptives in combination with a second contraceptive method (e.g., condom or occlusive cap). Proper contraception should be practiced during the entire participation in the study, including the follow-up period after the eight-week treatment.
- •Ability to monitor blood glucose concentration with a household glucometer and willingness to do so.
- •No major illness or weakness that, in the opinion of the researcher, prevents the subject from completing the study.
- •Ability to grant written informed consent and willingness to do so.
排除标准
- •History of cancer, other than spinocellular or basal cell carcinoma of the skin, that has not been in complete remission for at least three years before selection. (The history of treated cervical intraepithelial neoplasia I or II will be allowed).
- •History of treated diabetic gastroparesis.
- •Symptomatic ongoing biliary disease or a history of pancreatitis.
- •History of major gastrointestinal surgery, such as gastric bypass and elastic band placement, antrectomy, Roux Y-shunt, gastric vagotomy, small bowel resection or interventions that are thought to significantly affect upper gastrointestinal function.
- •Recent cardiovascular or cerebrovascular diseases with clinical importance
- •Hemoglobinopathy that may affect the determination of HbA1c.
- •History of infection by the human immunodeficiency virus.
- •History of total bilirubin> 1.5 times the upper limit of normal (LSN), unless the subject has a known history of Gilbert´s syndrome and a fractional bilirubin that reveals a conjugated bilirubin <35% of total bilirubin.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2.5 times the LSN.
- •Fasting triglyceride concentration> 850 mg / dl. If the subject´s triglyceride concentration is> 850 mg / dL at the time of selection, it may be treated and undergo a new selection. Treated subjects should receive a stable dose of medication for at least four weeks before undergoing a new selection.
- •Acute infection (during the three months prior to selection) by hepatitis B virus; however, the participation of subjects with past or chronic hepatitis B or C will be allowed provided that the requirements of ALT, AST and bilirubin are met
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
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 MellitusMedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitusType 2 Diabetes MellitusEUCTR2008-007661-24-GBGlaxoSmithKline LLC
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