EUCTR2005-004597-24-SE进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, five parallel groups study investigating the efficacy and safety of BI 1356 BS (1mg, 5mg and 10mg administered orally once daily) over 12 weeks as add-on therapy in patients with type 2 diabetes and insufficient glycaemic control despite metformin therapy, including an open-label glimepiride treatment arm.
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
- 500
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 alone or with metformin and one other oral antidiabetic drug other than rosiglitazone or pioglitazone (antidiabetic therapy has to be unchanged for 10 weeks prior to screening)
- •2.) Diagnosis of type 2 diabetes with a duration of at least 3 months
- •3.) Glycosylated haemoglobin A1 (HbA1c) 7.0 – 9.0 % at screening for patients treated with metformin and one other oral antidiabetic drug
- •Glycosylated haemoglobin A1 (HbA1c) 7.5 – 10.0 % at screening for patients treated with metformin alone
- •4.) Glycosylated haemoglobin A1 (HbA1c) 7.5 – 10.0 % at Visit 3 (beginning of the 2-week placebo run-in phase)
- •5.) Age >= 21 and <= 75 years
- •6.) BMI >= 25 and <= 40 kg/m2 (Body Mass Index)
- •7.) Signed and dated written informed consent prior to admission to the study 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.) Clinically relevant cardiovascular disease or myocardial infarction, stroke or TIA within six month prior to enrolment
- •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)
- •3.) Renal insufficiency or impaired renal function defined by serum creatinine above ULN at screening
- •4.) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurological disorders (including cerebrovascular) besides polyneuropathy that would interfere with participation in the trial
- •5.) Chronic or clinically relevant acute infections (e.g. HIV, Hepatitis)
- •6.) History of clinically relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
- •7.) Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
- •8.) Treatment with insulin within 3 month prior to screening
- •9.) Alcohol abuse within the last 3 months that would interfere with trial participation or drug abuse
- •10.) Participation in another trial with an investigational drug within two months prior to administration or during this trial
- •11.) Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at visit 2, 3 or 4 and confirmed by second measurement (not on the same day)
- •12.) Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who:
- •a) are nursing or pregnant,
- •b) 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, sexual abstinence and vasectomised partner. No exception will be made.
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