EUCTR2010-021375-92-ES进行中（未招募）不适用
A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type 2 diabetes mellitus
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
- 1,424
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. Diagnosis of type 2 diabetes mellitus prior to informed consent
- •2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomization
- •a. ? 7.0% and ? 10% (?53.0 mmol/mol and ?85.8 mmol/mol) at Visit 1 (screening) to be eligible for randomized treatment
- •b.> 10.0% (>85.8 mmol/mol) at Visit 1 (screening) to be eligible for the open-label arm
- •4. Age ? 18
- •5. Body Mass Index (BMI) ? 45 kg/m2 at Visit 1 (screening)
- •6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.
- •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 1140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 284
排除标准
- •1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
- •2. Any antidiabetic drug within 12 weeks prior to randomization
- •3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
- •4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in period
- •5. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
- •6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- •8. Known blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, hemolytic anemia)
- •9. Contraindications to metformin according to the local label
- •10. Treatment with anti-obesity drugs within 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
- •11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM.
- •12. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
- •- are nursing or pregnant or
- •- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomized partner
- •13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
- •14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial
- •15. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial in the opinion of the investigator
研究者
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