EUCTR2006-005492-17-SK进行中（未招募）1 期
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 plus Pioglitazone HCl (Actos?), SYR-322 Alone or Pioglitazone HCl Alone in Subjects with Type 2 Diabetes
Takeda Global Research & Development Centre (Europe) Ltd.,0 个研究点目标入组 580 人开始时间: 2007年1月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 580
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
- •Subject eligibility is determined based on the following criteria:
- •1. Males or females, 18-80 years of age, inclusive, with a historical diagnosis of type 2 diabetes.
- •2. The subject has failed treatment with diet and exercise for at least 2 months prior to Screening.
- •3. The subject is experiencing inadequate glycemic control as defined as HbA1c concentration between 7.5-11%, inclusive.
- •4. The subject has received less than 7 days of any antidiabetic therapy within 3 months prior to Screening.
- •5. The subject is capable of understanding and complying with protocol requirements.
- •6. The subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
- •7. The subject has a body mass index =23 kg/m2 and <45 kg/m2.
- •8. The subject has a fasting C-peptide =0.8 ng/mL (0.26 nmol/L).
- •9. The subject who has regular use of other, nonexcluded medications must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
- •10. Female subjects of child-bearing potential (ie, not surgically sterilized and/or postmenopausal) must be practicing adequate contraception (as defined in Section ?9.1.11 and the informed consent form) from Screening throughout the duration of the study.
- •11. The subject is neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
- •12. The subject must be willing and able to monitor their blood concentrations with a home glucose monitor.
- •Additional Inclusion Criteria Prior to Randomization
- •In order to be eligible for randomization, each of the following additional criteria must be satisfied with a Yes” answer:
- •1. The subject has a HbA1c concentration between 7.5-11%, inclusive, and a fasting plasma glucose <310 mg/dL (17.5 mmol/L) at the Week -1 visit (of note, if the subject does not qualify for randomization based on these criteria, the assessment may be repeated on a weekly basis, for a maximum of 4 additional weeks).
- •2. The subject has been at least 75% compliant with the single-blind placebo regimen during the run-in/stabilization period, as assessed by tablet count.
- •3. The subject has not used oral or systemically injected glucocorticoids or use of weight-loss drugs within 3 months prior to randomization (inhaled corticosteroids are allowed).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any subject who meets any of the following criteria will not qualify for entry into the study:
- •1. The subject has a systolic blood pressure =160 mmHg and diastolic blood pressure =100 mmHg.
- •2. The subject has hemoglobin =12 g/dL (120 gm/L) for males and =10 g/dL (100 gm/L) for females.
- •3. The subject has an alanine aminotransferase (ALT) =2.5x upper limit of normal.
- •4. The subject has a serum creatinine >2.0 mg/dL (177 micromol/L).
- •5. The subject has a thyroid stimulating hormone level > the upper limit of normal range.
- •6. The subject has a major illness or debility that in the investigator’s opinion prohibits the subject from completing the study.
- •7. The subject has a urine albumin/creatinine ratio of >1000 ug/mg (>113 mg/mmol) at Screening. If elevated, the subject may be rescreened within 1 week.
- •8. 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 CIN I or CIN II [cervical intraepithelial neoplasia] is allowed).
- •9. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- •10. The subject has a history of gastroparesis.
- •11. 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.
- •12. The subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- •13. The subject has a history of any hemoglobinopathy that may affect determination of HbA1c.
- •14. The subject has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- •15. The subject has a history of a psychiatric disorder that will affect the subject’s ability to participate in the study.
- •16. The subject has a history of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- •17. The subject has had any alteration in angiotensin-II receptor inhibitors (dose or drug) within 2 months prior to Randomization, if applicable.
- •18. The subject has a history of alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within 2 years prior to Screening.
- •19. The subject has received any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
- •20. The subject has previously participated in an investigational study of SYR-322.
- •21. The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
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