EUCTR2008-007444-34-DE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
Takeda Global Research & Development Centre (Europe) Ltd.0 个研究点目标入组 2,691 人开始时间: 2009年6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
- 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
- •Subject eligibility is determined according to the following criteria:
- •1. Male or female subjects, 18 to 80 years of age, inclusive with a historical diagnosis of T2DM
- •2. The subjects must meet one of the following:
- •a) 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 7.0 and 9.0%, inclusive. These subjects will immediately enter the stabilization period according to Study Schedule A.
- •b) 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 7.0 and 9.0%, inclusive.
- •3. No treatment with antidiabetic agents other than metformin within 2 months prior to Screening (for Schedule A) / Pre-Screening (for Schedule B) (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 2 months prior to Screening/Pre-Screening).
- •4. Body mass index (BMI) =23 kg/m2 and =45 kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be =20 kg/m2 and =35 kg/m2, inclusive.
- •5. Fasting C-peptide concentration =0.8 ng/mL (=0.26 nmol/L).
- •6. Subjects regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening/Pre-screening. However, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
- •7. A female subject of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study.
- •NOTE: Women NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation) or who are postmenopausal (defined as at least 45 years and above and at least 1 year since last regular menses). Acceptable methods of contraception are defined in Section 9.1.13 Contraception and Pregnancy Avoidance Procedure.
- •8. Subject or the subject’s legally acceptable representative is able and willing to provide written informed consent prior to the initiation of any study procedures.
- •9. The subject is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
- •10. Able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete subject diaries.
- •Additional Inclusion Criteria
- •In order to be eligible for randomization, each of the following additional criteria must be satisfied with a Yes” answer:
- •1. HbA1c concentration between 7.0% and 9.0%, inclusive, at the Week -1 visit. (Of note, if the subject does not qualify for randomization based on this criterion, the assessment may be repeated on a weekly basis, for a maximum of 2 additional weeks.)
- •2. FPG <275 mg/dL (15.27 mmol/L) at Week -1 visit. (Of note, if the subject does not qualify for randomization based on this criterion, the assessment
排除标准
- •Any subject who meets any of the following criteria will not qualify for entry into the study:
- •1. Systolic blood pressure =150 mm Hg and/or diastolic pressure =90 mm Hg at Screening Visit.
- •2. Hemoglobin =12 g/dL (=120 gm/L) for males and =10 g/dL (=100 gm/L) for females at Screening Visit.
- •3. Alanine aminotransferase >2.5 x upper limit of normal at Screening Visit.
- •4. Serum creatinine =1.5 mg/dL for males and =1.4 mg/dL for females or creatinine clearance <60 mL/min, based on calculation by central lab using the Cockcroft-Gault approximation at Screening Visit.
- •5. Subject plans to become pregnant during the study or is pregnant (confirmed by laboratory testing, ie, serum/urine hCG, in females of childbearing potential) or is lactating.
- •6. 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.)
- •7. Subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- •8. Subject has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
- •9. 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 (see Appendix E.)
- •10. Subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack (TIA) within the 3 months prior to Screening.
- •11. Subject has a history of any hemoglobinopathy that may affect determination of HbA1c.
- •12. Subject has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- •13. Subject has a history of any psychiatric disorder that will affect the subject’s ability to participate in the study.
- •14. Subject has a history of alcohol or substance abuse within the 2 years prior to Screening.
- •15. 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.
- •16. Subject has received any antidiabetic drug in the DPP-IV inhibitors or GLP-1 mimetics classes within 90 days prior to Screening.
- •17. Subject has any major illness or debility that in the investigator’s opinion prohibits the subject from completing the study.
- •18. Subject has participated in a previous investigational study of alogliptin that has completed and received alogliptin treatment.
- •19. The 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.
- •20. The subject has a history of hypersensitivity, allergies, or have had an anaphylactic reaction(s) to any DPP-IV inhibitor drug, metformin or glipizide.
- •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.
- •22. Subject has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
研究者
相似试验
进行中（未招募）
不适用
A Controlled Study to Investigate the Effectiveness and Safety of TAK-875 Compared to Glimepiride When Used in Combination with Metformin in Individuals Diagnosed with Type 2 DiabetesEUCTR2011-001731-24-BGTakeda Development Centre Europe Ltd.2,610
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 - NDPatients with type II diabetes mellitus (T2DM) who are currently treated with a stable daily dose of metformin alone but experiencing inadequate glycemic controlMedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2008-007444-34-ITTakeda Global Research & Development Centre (Europe) Ltd2,691
进行中（未招募）
不适用
A Controlled Study to Investigate the Effectiveness and Safety of TAK-875 Compared to Glimepiride When Used in Combination with Metformin in Individuals Diagnosed with Type 2 DiabetesType 2 diabetes mellitus (T2DM)MedDRA version: 16.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 16.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001731-24-LTTakeda Global Research & Development Centre (Europe) Ltd.2,610
进行中（未招募）
1 期
A Controlled Study to Investigate the Effectiveness and Safety of TAK-875 Compared to Glimepiride When Used in Combination with Metformin in Individuals Diagnosed with Type 2 DiabetesEUCTR2011-001731-24-GBTakeda Development Centre Europe Ltd.2,454
进行中（未招募）
1 期
A Controlled Study to Investigate the Effectiveness and Safety of TAK-875 Compared to Glimepiride When Used in Combination with Metformin in Individuals Diagnosed with Type 2 DiabetesType 2 diabetes mellitus (T2DM)MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-001731-24-CZTakeda Development Centre Europe Ltd.2,610