EUCTR2009-016244-39-IT进行中（未招募）不适用
A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment - CASCADE-7
BOEHRINGER ING.0 个研究点目标入组 2,900 人开始时间: 2010年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,900
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 maximum tolerated dose of metformin (preferably >= 1500mg) unchanged for 12 weeks prior to randomisation. Please note: Type 2 diabetes mellitus patients treated with less than 1500 mg metformin per day can only be included if the investigator considers the patient to be on the maximum tolerated dose and the investigator has documented the reason why uptitration to 1500 mg was not possible. Pre-treatment with extended or sustained release metformin will not be allowed. 3. HbA1c of >= 7.0% and <= 10% at Visit 1 (screening). 4. Age >= 18yrs 5. BMI <= 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 (as stated above patients on extended or sustained release metformin are to be excluded). 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 during screening and/or run-in phase. 5.Impaired renal function, defined as eGFR<60 ml/min (moderate to severe renal impairment using MDRD formula) as determined during screening and/or run-in phase. 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 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. 11. 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 T2DM. (Treatment with local and inhaled steroids is allowed). 12. 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 practising 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. 13. 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. 14. Participation in another trial with an investigational drug within 30 days prior to informed consent. 15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.
研究者
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