EUCTR2006-000006-23-HU进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluatethe Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy inSubjects with Type 2 Diabetes Who Have Inadequate Glycemic Control.Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific
适应症
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
- 2,940
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) Subjects must be willing and able to give written informed consent.
- •2) Subjects with a diagnosis of type 2 diabetes mellitus.
- •3) A1C = 8% but = 12% obtained at the screening visit.
- •4) Fasting C-peptide concentration = 1.0 ng/ml.
- •5) Subjects will be drug naïve. Drug naïve subjects are defined as subjects who have
- •never received medical treatment for diabetes (insulin and/or oral hypoglycemic
- •agents) or have received medical treatment for diabetes for less than a total of one
- •month since original diagnosis. In addition, subjects should not have received any
- •antihyperglycemic therapy for more than three consecutive days or a total of seven
- •non-consecutive days during the 8 weeks prior to screening. The exceptions are for
- •women who have received treatment for gestational diabetes during their pregnancy
- •and are no longer receiving therapy or subjects who during a hospitalization received
- •a short course of insulin treatment.
- •6) Body mass index = 40 kg/m2.
- •7) Men and women, ages 18 to 77. Women must be non-nursing and non-pregnant.
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
- •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
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- •2) WOCBP using a prohibited contraceptive method.
- •3) Women who are pregnant or breastfeeding.
- •4) Women with a positive pregnancy test on enrollment or prior to study drug
- •administration.
- •5) Symptoms of poorly controlled diabetes that would preclude participation in this
- •active-controlled trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms.
- •6) History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •7) Insulin therapy within one year of screening (with the exception of insulin therapy
- •during a hospitalization or use in gestational diabetes).
- •8) Significant cardiovascular history defined as:
- •a/ History of myocardial infarction, coronary angioplasty or bypass graft(s), valvular
- •disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study.
- •b/ Congestive heart failure defined as New York Heart Association (NYHA) stage
- •III and IV (see Protocol Appendix 2) and/or known left ventricular ejection fraction of = 40%.
- •9) Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid therapy may be enrolled).
- •10) History of unstable or rapidly progressing renal disease.
- •11) History of alcohol or drug abuse within the previous one year.
- •12) Unstable major psychiatric disorders.
- •13) Immunocompromised individuals such as subjects that have undergone organ
- •transplantation or subjects diagnosed with human immunodeficiency virus.
- •14) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic
- •15) Donation of blood or plasma to a blood bank within three months of screening.
- •16) Administration of any other investigational drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period of duration if dictated by local regulatory guidelines).
- •17) Any condition which in the Investigator’s opinion may render the subject unable to complete the study or which may pose significant risk to the subject.
- •18) Physical and Laboratory Test Findings
- •19) Active liver disease and/or significant abnormal liver function defined as AST > 2x
- •ULN and/or ALT > 2x ULN and /or serum total bilirubin > 2.0 mg/dL.
- •20) History of positive serologic evidence of current infectious liver disease including
- •anti-HAV (IgM), HbsAg, or anti-HCV. Subjects who may have isolated positive anti
- •HBs may be included.
- •21) Serum creatinine (Scr) = 1.5 mg/dL (132.6 µmol/L) for males and = 1.4 mg/dL (123.8µmol/L) for females.
- •22) Creatine Kinase = 3x ULN.
- •23) Anemia, of any etiology defined as hemoglobin = 12.0 g/dL (120 g/L) for men andhemoglobin = 11.0 g/dL (110 g/L) for women.
- •24) Absolute lymphocyte count less than 1000 cells/mm³.
- •25) Platelet count < 140,000 cells/µL.
- •26) Subjects that have an abnormal TSH value at screening will be further evaluated by free T4. Subjects with an abnormal free T4 will be excluded.
- •27) Subjects who have contraindications to therapy as outlined in the Saxagliptin
- •Investigator Brochure, metformin package insert, or pioglitazone package insert.
- •28) History of administration of any antihyperglycemic therapy for a total of one month or for more than three cons
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