A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared with Sulphonylurea all given as Add-on Therapy to Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

AstraZeneca AB0 个研究点目标入组 930 人开始时间: 2015年7月24日最近更新: 2017年8月21日

研究概览

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•Main Inclusion Criteria:
•1. Is male or female and =18 and <75 years old at time of informed consent.
•2. Has a HbA1c of =7.5% and =10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
•3. Currently treated with a stable maximum tolarated dose (MTD) (=1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
•4. Has a BMI of =45 kg/m2 at Enrolment visit.
•5. Has a C-peptide laboratory value of =1.0 ng/mL (0.33 nmol/L; 331 pmol/L) based on central laboratory results from Visit 1.
•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 700
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 230

•1.Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
•2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient’s safety and/or the interpretation of efficacy or safety data.
•3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
•4. Concomitant treatment with loop diuretics

发起方