A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

BRISTOL MYERS SQUIBB COMPANY,0 个研究点目标入组 0 人开始时间: 2008年12月1日最近更新: 2023年9月4日

适应症

试验速览

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•Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
•All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
•C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
•Body Mass Index ≤ 45.0 kg/m²

•MEF who do not want or are not able to use an acceptable method to avoid pregnancy during the entire period of the study.
•Women who are pregnant or breastfeeding
•Women with positive pregnancy test at enrollment or before administration of the experimental product.
•Albumin: urine creatinine ratio (UACR)> 1800 mg / e (203.4 mg / mmol / Cr).
•Aspartate Aminotransferase (AST)> 2.5 X normal upper limit (LSN).
•Alanine Aminotransferase (ALT)> 2.5 X ULN.
•Total serum bilirubin (BT)> 2 mg / dl (34.2 pmol / 1).
•Serum creatinine (Ser)> 2.0 mg / dl
•Clearance of Cr calculated <50 ml / min (calculated with the Cockroft-Gault formula).
•Calcium value outside the normal reference range of the central laboratory.
•Positive for hepatitis B surface antigen.
•Positive for hepatitis C virus antibody
•Hemoglobin <11.0 g / dl (110 g / 1) for men; hemoglobin <10.0 g / dl (100 g / l) for women.
•Creatine kinase (CK)> 3XLSN. ;
•Abnormal T4 values. An abnormal value of the thyroid-stimulating hormone (TSH) in the enrollment will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded.
•History of diabetes insipidus.
•Symptoms of poorly controlled diabetes that would prevent participation in this trial, including, but not limited to, marked polyuria and polydipsia with more than 10% weight loss during the three months prior to enrollment, or other signs and symptoms.
•History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.

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