A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial with a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin Compared to Insulin Glargine in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin with or without Sulfonylurea Therapy

AstraZeneca AB0 个研究点目标入组 598 人开始时间: 2015年11月11日最近更新: 2018年8月27日

适应症

试验速览

暂无简介。

•Males and females aged = 18 years old at the time of screening visit.
•Subjects with T2DM with inadequate glycemic control, defined as a central laboratory HbA1c = 8 % and = 12 % obtained at the screening visit.
•Subjects must be taking a stable dose of metformin = 1500 mg/day for at least 8 weeks prior to screening visit with or without a stable dose of SU of at least 50% maximal dose per local label for at least 8 weeks prior to screening visit. Subjects must not take any other antidiabetic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening.
•BMI = 45.0 kg/m2 at the screening visit.
•Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) at screening and within 24 hours prior to the start of study drug.
•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 478
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•Clinical diagnosis of Type 1 Diabetes.
•History of diabetic ketoacidosis
•History of unstable or rapidly progressing renal disease, hepatic insufficiency or current, acute or chronic pancreatitis.
•Any of the following cardiovascular/vascular diseases within 3 months of enrollment visit: myocardial infarction (MI), coronary arterial bypass
•graft (CABG), percutaneous coronary intervention (PCI), valvular
•disease or repair, unstable angina or unstable congestive heart failure
•(CHF), transient ischemic attack (TIA), Class III or IV heart failure, known left ventricular ejection fraction of < 40%, or significant cerebrovascular disease.
•Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min [estimated by Cockcroft-Gault] or serum creatinine [SCr] = 1.5 mg/dL in males subjects or = 1.4 mg/dL in females subjects).
•Bladder cancer
•Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization.
•Other hematological or oncological diseases or conditions.
•Participation in a commercial weight loss program or history of bariatric surgery.
•Replacement or chronic systemic corticosteroid therapy.
•Administration of any other investigational drug or participation in any interventional clinical study within (30) days prior to screening for this study.

发起方