EUCTR2007-004585-40-GB进行中（未招募）不适用
A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 1356 (5.0 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy
适应症
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
- 2,400
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. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin monotherapy, or with metformin plus one other oral antidiabetic drug (the antidiabetic therapy must be stable (i.e. unchanged) for 12 weeks prior to randomisation
- •Please note: Type 2 diabetes mellitus patients should be on a stable daily dose of preferably >= 1500 mg of metformin. Patients with less than 1500 mg Metformin per day will only be included if the investigator considers them on their maximum tolerated dose
- •The metformin dose should not be increased or decreased during the trial
- •2. Diagnosis of type 2 diabetes prior to informed consent
- •3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
- •For patients undergoing wash-out of previous medication: HbA1c 6.0 – 9.0%
- •For patients not undergoing wash-out of previous medication: HbA1c 6.5 – 10%
- •4. Glycosylated haemoglobin A1 (HbA1c) 6.5 – 10.0% at Visit 2 (Start of Run-in)
- •5. Age >= 18 and <= 80 years at Visit 1a (Screening)
- •6. Body Mass Index (BMI) <= 40 kg/m2 at Visit 1a (Screening)
- •7. Signed and dated written informed consent at the latest by the date of Visit 1a, 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. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
- •2. Impaired hepatic function, 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 1a (Screening)
- •3. Known hypersensitivity or allergy to the investigational product or its excipients), metformin or Sulfonyureas (glimepiride)
- •4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
- •5. Treatment with insulin or injectable GLP-1 analogue/agonists within 3 months prior to informed consent
- •6. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent
- •7. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones (within 6 weeks prior to informed consent)
- •8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation
- •9. Drug abuse
- •10. Participation in another trial with an investigational drug within 2 months prior to informed consent
- •11. Pre-menopausal women (last menstruation <= 1 year prior to signing 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 transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partner. No exception will be made.
- •12. Renal failure or renal impairment ( serum creatinine >1.5 mg/dl as determined at Visit 1a)
- •13. Hereditary galactose intolerance
- •14. Diagnosis of Type 1 Diabetes
- •15. Patients in diabetic coma or ketoacidosis
- •16. Known hypersensitivity or allergy to sulphonamides or other sulfonylureas
研究者
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