EUCTR2009-016244-39-NO进行中（未招募）1 期
A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 (25 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin therapy - Cascade 7
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,637
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 pre-treated with a stable maximum tolerated dose of metformin unchanged for 12 weeks prior to randomisation. (Preferably >/= 1500mg/day metformin)
- •3. HbA1c of more than or equal to 7.0% and less or equal to 10.0% at Visit 1 (screening)
- •4. Age more than or equal to 18yrs
- •5. BMI more or than or equal to 45 kg/m2 (Body Mass Index) 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 drug within 12 weeks prior to randomisation except metformin
- •3. Myocardial infarction, stroke or 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 at Visit 1
- •5. Impaired renal function, defined as eGFR<60 ml/min (moderate to severe impairment calculated using MDRD formula)
- •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. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
- •9. Contraindications including hypersensitivity known to metformin or sulfonylureas according to the local label
- •10. Treatment with glitazones, insulin or GLP- analogues or agonists 3 months prior to randomisation
- •11. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 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
- •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 any other uncontrolled endocrine disorder except T2D. (Treatment with local and inhaled steroids is allowed)
- •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, double barrier method and vasectomised partner
- •14. 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
- •15. Participation in another trial with an investigational drug within 30 days prior to informed consent
- •16. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
研究者
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