EUCTR2008-007444-34-IT进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes - ND
Takeda Global Research & Development Centre (Europe) Ltd0 个研究点目标入组 2,691 人开始时间: 2009年7月15日最近更新:
适应症
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
- 2,691
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
- •Male or female subjects, 18 to 80, years of age, inclusive with a historical diagnosis of T2DM. The subjects must meet one of the following: The subject has been inadequately controlled on a stable daily dose of 1500 mg (or documented MTD) of metformin for at least 2 months prior to Screening. Inadequate glycemic control is defined as an HbA1c concentration between 6.5 and 9.0%, inclusive. These subjects will immediately enter the stabilization period according to Study Schedule A or the subject has been inadequately controlled (as defined by an HbA1c 7.5 10%, inclusive) on metformin <1500 mg without documented MTD. After completing the Pre-screening visit, these subjects will have their metformin dose immediately increased to 1500 mg (or MTD) for an 8 week period according to Study Schedule B. Following this 8-week period, the subject must qualify for entry into the stabilization period by completing the Screening Visit having inadequate glycemic control defined as an HbA1c concentration between 6.5 and 9.0%, inclusive. No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 2 months prior to Screening). Body mass index (BMI) 23 kg/m2 and 45 kg/m2. Fasting C-peptide concentration 0.8 ng/mL (0.26 nmol/L). Subjects regularly using other, non-excluded medications, must be on a stable dose for at least the 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. Females of childbearing potential (ie, not surgically sterile and/or not postmenopausal) and male subjects who are sexually active must be practicing adequate contraception. Subject is able and willing to provide written informed consent. The subject is capable of understanding and complying with protocol requirements, including scheduled clinic appointments. The subject is able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete subject diaries.
- •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
- •Subjects who have a systolic blood pressure 150 mm Hg and/or diastolic pressure 90 mm Hg at Screening Visit. Subjects who have the following clinical lab test results: Hemoglobin 12 g/dL (120 gm/L) for males and 10 g/dL (100 gm/L) for females, Alanine aminotransferase >2.5 x upper limit of normal, Serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females or creatinine clearance 50mL/min, based on calculation by central lab using the Cockcroft-Gault approximation. Subject plans to become pregnant during the study or is pregnant (confirmed by laboratory testing, i.e. serum/urine hCG, in females of childbearing potential) or is lactating. 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, II or CIN III [cervical intraepithelial neoplasia] is allowed.) Subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. Subject has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 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). Subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction (MI), stroke or transient ischemic attack (TIA) within the 3 months prior to Screening. Subject has a history of any hemoglobinopathy that may affect determination of HbA1c. Subject has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV). Subject has a history of any psychiatric disorder that will affect the subject?s ability to participate in the study. Subject has a history of alcohol or substance abuse within the 2 years prior to Screening. 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. Subject has received any antidiabetic drug in the DPP-IV inhibitors or GLP-1 mimetics classes at any time prior to Screening. Subject has any major illness or debility that in the investigator?s opinion prohibits the subject from completing the study. Subject has had prior treatment in an investigational study of alogliptin. Subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, and sibling) of a study site employee who is involved in conduct of this study. The subject has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any DPP-IV inhibitor drug, metformin or glipizide. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. If male, the subject intends to impregnate others or donate sperm during such time period. 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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