EUCTR2009-012612-41-LT进行中（未招募）不适用
A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group study, with an Optional 2-Month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
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.Provision of informed consent prior to any study specific procedures.
- •2.Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged = 18. Women will be defined as postmenopausal if last menstruation period was >1 year ago and serum FSH and LH are within the postmenopausal range, or if age >50 years and with last menstruation period >2 years ago.
- •3.Body mass index between = 19 and = 42 kg/m2.
- •4.Clinical diagnosis of T2DM.
- •5.Treated with maximally tolerated dose of metformin (= 1500mg/day) for at least 10 weeks prior to enrolment.
- •6.Patients with HbA1c = 7.5 but = 10% at enrolment visit (Visit 1) (HbA1c value according to international DCCT standard and obtained from the central laboratory used in the study) can enter cohort 1. Patients with HbA1c between >10 % and <12 % can enter the open-label arm with AZD1656 (cohort 2)
- •7.Patients must have taken at least 75% of their metformin tablets during the run-in period (ie, from Visit 2 to Visit 3).
- •For inclusion in the optional genetic research, patients must fulfil all of the inclusion criteria described above and:
- •Provide informed consent for the genetic sampling and analyses.
- •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
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled
- •1.Clinical diagnosis of Type 1 diabetes.
- •2.Positive test for Hepatitis B surface antigen or antibodies to HIV virus or antibodies to Hepatitis C virus. Results obtained from the central laboratory will be utilised.
- •3.Participation in weight loss programme (other than the lifestyle advice normally given to T2DM patients) or use of weight loss drugs (OTC or prescriptions) in the last 3 months
- •4.Participation in another clinical trial within 30 days prior to enrolment.
- •5.Unwilling or unable to perform self-monitoring of plasma glucose at home according to protocol.
- •6.Significant cardiovascular event within the last 6 months prior to enrolment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV.
- •7.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results >3xULN at enrolment, obtained from the central laboratory used in the study.
- •8.Haemoglobin laboratory results <115 g/L at enrolment, obtained from the central laboratory used in the study.
- •9.History of psychiatric or somatic disease/condition (eg, gastrointestinal disease) that may interfere with the objectives of the study, as judged by the investigator.
- •10.History or ongoing symptoms/signs of severe allergy/hypersensitivity as judged by the investigator.
- •11.Known allergy to glipizide.
- •12.History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma or in-situ carcinoma of the cervix.
- •13.Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculationa.
- •14.Past or present alcohol or drug abuse within the last 5 years or positive test in drugs of abuse screens.
- •15.SBP >160 mmHg or DBP >95 mmHg at enrolment/screening.
- •16.Treatment with any other anti-diabetic agent than metformin during the last 10 weeks prior to enrolment/screening.
- •17.Proliferative retinopathy or other significant diabetes complications as judged by the investigator.
- •18.Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.
- •19.Use of anabolic steroids and systemic treatment with glucosteroids within 3 months before enrolment. Inhalation steroid treatment allowed.
- •20.Blood loss in excess of 450 mL 3 months prior to enrolment.
- •21.Intake of another investigational drug within 30 days (or at least 5 t1/2 of the drug, if longer than 30 days) before enrolment.
- •22.Prior exposure to GKAs.
- •23.Involvement in the planning and conduct of the study or staff at the investigational site.
- •24.Any other condition prohibiting the patient from participating in the study according to the protocol as judged by the investigator.
- •25.Previous bone marrow transplant (applicable only for genetic sampling).
- •26.Whole blood transfusion within 120 days of the date of genetic sample collection (applicable only for genetic sampling).
- •27.Unable or unwilling to use basal night-time insulin as rescue treatment during the study period in case of hyperglycaemia.
- •Procedures for withdrawal of incorrectly enrolled patients are presented in Section 1.1.
研究者
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