EUCTR2007-002450-28-BE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg) administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with a sulphonylurea
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 800 人开始时间: 2008年1月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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, currently treated only with a stable total daily dose of preferably* more than or equal to 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
- •2. Glycosylated haemoglobin A1 (HbA1c) more than or equal to 7.0 and less than or equal to 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
- •3. Age more than or equal to 18 and less than or equal to 80 years at Visit 1a (screening)
- •4. BMI (Body Mass Index) less than or equal to 40 kg/m2 at Visit 1a (screening)
- •5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation
- •*Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.
- •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 (transient ischaemic attack) within 6 months prior to the date of informed consent
- •2. Impaired hepatic function, defined by serum levels of either alanine transaminase, ALT (SGPT), aspartase transaminase, AST (SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
- •3. Renal failure or renal impairment (serum creatinine more than or equal to 1.5 mg/dl) as determined at Visit 1a
- •4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
- •5. Treatment with GLP-1 analogues (e.g. exanatide) within 3 months prior to the date of informed consent
- •6. Treatment with insulin within 3 months prior to the date of informed consent
- •7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
- •8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
- •9. Pre-menopausal women (last menstruation less than or equal to 1 year prior to the date of 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 periodic pregnancy testing during their 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.
- •10. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
- •11. Dehydration (as confirmed by the Investigator’s clinical opinion)
- •12. Current acute or chronic metabolic acidosis
- •13. Hereditary galactose intolerance
- •14. Alcohol abuse within 3 months prior to the date of informed consent that, in the Investigator’s opinion, would interfere with participation in the trial
- •15. Drug abuse
- •16. Participation in another trial with an investigational product within 2 months prior to the date of informed consent
- •17. Any other clinical condition which, in the Investigator’s opinion, would interfere with participation in the trial and patient safety
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