EUCTR2012-000905-53-PL进行中（未招募）不适用
A randomised, double blind, placebo controlled, parallel group efficacy and safety study of oral administration of empagliflozin twice daily versus once daily in two different daily doses over 16 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 936
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 currently
- •treated with metformin (IR) alone.
- •A total daily dose of =1500 mg/day metformin divided into twice daily administration (e.g., 850 mg bid, 1000 mg bid, 850/1000 mg bid or 500/1000 mg bid) is required for inclusion into the trial. A patient taking metformin tid can be included if switched to a biddosing regimen at the time of informed consent. In this case, the total daily dose must be maintained (e.g., 500 mg tid to 1000/500 mg bid, 1000/500/500 mg tid to 1000 bid, 500/500/850 mg tid to 1000/850 mg bid).
- •3. The total daily dosage of metformin needs to be stable for at least 12 weeks prior to randomisation and is expected to be stable throughout the duration of the study.
- •4. HbA1c = 7.0% and = 10% (=53.0 mmol/mol and =85.8 mmol/mol) at Visit 1 (screening)
- •5. Age =18 at Visit 1 (screening)
- •6. BMI =45 kg/m2 (Body Mass Index) at Visit 1 (screening).
- •7. 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 702
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 234
排除标准
- •1. Uncontrolled hyperglycaemia 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 other antidiabetic medication within 12 weeks prior to
- •randomisation, except the one defined as the permitted background therapy via inclusion criterion no. 2
- •3. Treatment with extended release formulations of metformin within12 weeks prior to consent
- •4. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent.
- •5. 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
- •6. 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
- •7. Bariatric surgery within the past two years and other
- •gastrointestinal surgeries that induce chronic malabsorption
- •8. Known medical history of cancer (except for basal cell carcinoma)
- •and/or treatment for cancer within the last 5 years
- •9. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell (e.g. malaria, babesiosis, haemolytic anaemia)
- •10. Contraindications to metformin according to the local label (e.g.
- •11. Treatment with anti-obesity drugs 3 months prior to informed
- •consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) which, in the opinion of Investigator, may lead to unstable body weight
- •12. 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 other uncontrolled endocrine disorder (except T2DM)
- •13. 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, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
- •14. Alcohol or drug abuse within the 3 months prior to informed
- •consent that, in the opinion of Investigator, would interfere with trial participation or any ongoing condition leading to a decreased
- •compliance to study procedures or study drug intake.
- •15. Intake of an investigational drug in another trial within 30 days
- •prior to intake of study medication in this trial
- •16. Any other clinical condition that, in the opinion of the Investigator, would jeopardize patient's safety while participating in this clinical trial
研究者
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