EUCTR2007-000486-38-NL进行中（未招募）不适用
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group StudyComparing SYR-322 Alone and Combination SYR-322 with Pioglitazone versus Placebo on Postprandial Lipids in Subjects with Type 2 Diabetes - Post-Prandial
Takeda Global Research & Development Centre (Europe) Ltd.,0 个研究点目标入组 71 人开始时间: 2008年5月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
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 according to the following criteria:
- •1. The subject is male or female, with a historical diagnosis of type 2 diabetes, and must be aged 18 to 70 years, inclusive.
- •2. A female subject of childbearing potential who is sexually active agrees to use adequate contraception from screening throughout the duration of the study. Women NOT of child bearing potential are defined as those who have been surgically sterilized (hysterectomy, oophorectomy, tubal ligation) or who are post-menopausal (defined as at least 2 years since last regular menses). Acceptable methods of contraception are defined in Section 9.1.11 Contraception and Pregnancy Avoidance Procedure.
- •3. The subject is capable of understanding and complying with the protocol requirements.
- •4. The subject has either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nataglinide, or repaglinide for more than 3 months prior to Screening.
- •5. The subject has inadequate glycemic control as defined by A1C concentration between 6.5 and 9.0%, inclusive.
- •6. The subject has a fasting plasma glucose <13.3 mmol/L.
- •7. The subject has a fasting serum triglyceride level of 1.7 to 5.0 mmol/L, inclusive.
- •8. The subject has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
- •9. The subject has a body mass index >23 kg/m2 and <45 kg/m2.
- •10. If the subject has regular use of other, nonexcluded medications, subject must be on a stable dose for at least 4 weeks prior to Screening. Use of PRN (as needed) prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
- •11. The subject or subject’s legally authorized representative signs a written informed consent prior to the initiation of any study procedures.
- •12. The subject is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline
- •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 history of type 1 diabetes.
- •2. The subject has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
- •3. The subject has a diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
- •4. The subject has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.)
- •5. The subject has a hemoglobin <120 g/L for males and <100 g/L for females.
- •6. The subject has an alanine transaminase (ALT) level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- •7. The subject has a serum creatinine level >133 µmol/L.
- •8. The subject has a fasting total cholesterol >6.5 mmol/L.
- •9. The subject has New York Heart Association heart failure of any Class (I-IV)
- •regardless of therapy.
- •10. The subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- •11. The subject has a history of acute metabolic diabetic complications.
- •12. The subject has a history of any hemoglobinopathy that may affect determination of A1C.
- •13. The subject has a history of infection with human immunodeficiency virus.
- •14. The subject has a history of diabetic gastro paresis.
- •15. The subject has a history of gastric bypass surgery.
- •16. The subject is unwilling or unable to comply with the protocol or scheduled appointments.
- •17. The subject has a history of hypersensitivity or allergies to SYR-322, pioglitazone or any related compounds.
- •18. The subject is pregnant, intends to become pregnant during the course of the study, or is lactating.
- •19. The subject is currently participating in another investigational study or has participated in an investigational study within the past 30 days.
- •20. The subject has any other serious disease or condition at Screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
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