PER-041-06已完成未知
MULTI-CENTER PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLED ASSAY TO EVALUATE THE EFFICACY AND SAFETY OF SAXAGLIPTIN (BMS-477118) IN COMBINATION WITH THIAZOLIDINEDIONA THERAPY IN SUBJECTS WITH TYPE 2 DIABETES WITH INAPPROPRIATE GLYCEMIC CONTROL UNDER TREATMENT WITH MONOTHERAPY OF THIAZOLIDINEDIONE
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1) Subjects must be willing to give written informed consent and be able to do so.
- •2) Subjects with type 2 diabetes who have received treatment with a stable monotherapy dose of a TZD (pioglitazone 30mg or 45mg, once a day, or rosiglitazone 4mg, once a day, or 8mg, either once a day or in two doses of 4mg) for at least 12 weeks before selection.
- •3) A1C ≥ 7.0% and ≤ 10%.
- •4) Fasting peptide-C concentration ≥ 1.0 ng / ml.
- •5) Body mass index ≤ 40 kg / m2.
- •6) Men and women, ≥18 and ≤77 years of age. Women should not be breastfeeding or pregnant. Women of childbearing age (WOCBP) should use adequate contraception to avoid pregnancy during the study and up to 4 weeks after the study.
排除标准
- •1) WOCBP who do not wish or can not use an acceptable method to avoid pregnancy during the entire course of the study and up to 4 weeks after the study.
- •2) WOCBP using a prohibited method of contraception.
- •3) Pregnant or lactating women.
- •4) Women with a positive pregnancy analysis at the time of admission or prior to the administration of the study medication.
- •5) Symptoms of poorly controlled diabetes.
- •6) History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- •7) Insulin therapy within the year prior to selection.
- •8) Important cardiovascular antecedents.
- •9) Repeated or chronic intermittent corticosteroid treatment.
- •10) History of instable or rapidly evolving renal disease.
- •11) History of drug or alcohol abuse within the previous year.
- •12) Unstable major psychiatric disorders.
- •13) Immunocompromised individuals.
- •14) History of hemoglobinopathies.
- •15) Donation of blood or plasma to a blood bank within three months of the selection.
- •16) Administration of any other medication in research or participation in a clinical research trial within 30 days prior to randomization.
- •17) Any table that may incapacitate the subject to complete the study or may pose a significant risk to it.
- •18) Liver disease and / or significant abnormal liver function.
- •19 History of positive serological evidence of current infectious liver disease.
- •20) Serum creatinine (Scr)> 2.0 mg / dL (176 μmol / L).
- •21) Creatine kinase ≥ 3x ULN.
- •22) Anemia of any etiology defined as hemoglobin ≤ 12.0 g / dL (120 g / L) in men and hemoglobin ≤ 11.0 g / dL (110 g / L) in women.
- •23) Absolute lymphocyte count less than 1000 cells / mm3.
- •24) Platelet count <140,000 cells / uL.
- •25) Subjects with an abnormal TSH value in the selection will be subjected to an additional evaluation of free T4. Subjects with abnormal free T4 will be excluded.
- •26) Subjects that present contraindications for therapy.
- •27) Background of administration of any antihyperglycemic therapy for twelve weeks before selection.
- •28) Treatment with potent systemic inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4).
- •29) Previous treatment with saxagliptin or any DPP-IV inhibitor.
- •30) Prisoners or subjects who are required to be detained for treatment because of a psychiatric or physical illness.
研究者
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