EUCTR2007-000240-27-LT进行中（未招募）不适用
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, MulticenterStudy to Evaluate Weekly Treatment with SYR-472 in Subjects with Type 2 Diabetes. - TAK472-007
Takeda Global Research & Development Centre (Europe) Ltd0 个研究点目标入组 369 人开始时间: 2007年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 369
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
- •1. The subject is male or female, aged 18 to 80 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus.
- •2. The subject is capable of understanding and complying with the protocol requirements.
- •3. The subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
- •4. The subject has undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
- •5. The subject receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run-in/Stabilization Period as determined by subject diary and investigator assessment.
- •6. The subject has received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening. (Exception: if the subject has received other antidiabetic therapy for less than 7 days within the 8 weeks prior to Screening.)
- •7. The subject has an HbA1c concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
- •NOTE: If the subject does not qualify based on this criterion, the assessment may be repeated on a weekly basis, for a maximum of 2 additional weeks.
- •8. The subject has a body mass index (BMI) between 23 and 45 kg/m2 .
- •9. The subject’s fasting C-peptide concentration is =0.8 ng/mL (= 0.26 nmol/L).
- •10. The subject’s FPG concentration is <275 mg/dL (<15.27 mmol/L) at Screening and at the Week -1 Visit.
- •NOTE: If the subject does not qualify based on this criterion, the assessment may be repeated on a weekly basis, for a maximum of 2 additional weeks.
- •11. If the subject regularly uses other nonexcluded medications, he or she must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter (OTC) medications is allowed at the discretion of the investigator.
- •12. The subject has a systolic blood pressure reading of <160 mm Hg and a diastolic pressure reading of <100 mm Hg.
- •13. The subject has a hemoglobin value =12 g/dL (=120 g/L) for men and =10 g/dL (=100 g/L) for women.
- •14. The subject’s alanine aminotransferase level is =3 times the upper limit of normal (ULN).
- •15. A male subject has a serum creatinine value of <1.5 mg/dL (<133 µmol/L); a female subject has a serum creatinine value of <1.4 mg/dL (<124 µmol/L).
- •16. The subject has a urine albumin/creatinine ratio of <1000 µg/mg at Screening.
- •17. The subject has a thyroid-stimulating hormone level = the ULN range and the subject is clinically euthyroid.
- •18. A female subject must be neither pregnant nor lactating. A female subject of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test at Screening and within 1 day prior to administration of the first dose of study medication.
- •19. A female subject of childbearing potential who is sexually active must agree to use adequate contraception (as defined in the informed consent form) from Screening and throughout the duration of the study.
- •20. The subject is able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor.
- •21. The subject has no major illness or debility that in the investigator’s opinion prohibits the subject from completing the st
排除标准
- •1. The subject is being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
- •2. The subject has a history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia [CIN I] or CIN II is allowed.)
- •3. The subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- •4. The subject has a history of treated diabetic gastric paresis.
- •5. The subject has New York Heart Association class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at class I or II are candidates for the study.
- •6. The subject has a history of coronary angioplasty, underwent coronary stent placement or coronary bypass surgery, or suffered a myocardial infarction, or stroke within the 6 months prior to Screening.
- •7. The subject has a history of any hemoglobinopathy that may affect determination of HbA1c.
- •8. The subject has a history of infection with human immunodeficiency virus.
- •9. The subject has a history of a psychiatric disorder that in the investigator’s opinion will affect the subject’s ability to participate in the study.
- •10. The subject has a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within the 2 years prior to Screening.
- •11. The subject has ingested or received systemically injected glucocorticoids within the 3 months prior to randomization. Inhaled corticosteroids are allowed.
- •12. The subject has used prescription or over-the-counter weight-loss drugs within the 3 months prior to randomization.
- •13. The subject has received any investigational drug within the 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
- •14. The subject has received previous treatment in an investigational study of SYR-472.
- •15. The subject has a known hypersensitivity to any compound related to SYR-472.
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A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, MulticenterStudy to Evaluate Weekly Treatment with SYR-472 in Subjects with Type 2 Diabetes. - TAK472-007Type 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2007-000240-27-LVTakeda Global Research & Development Centre (Europe) Ltd167