EUCTR2009-016244-39-PT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 with a 104-week extension period in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment - EMPA-REG H2H-S
nilfarma, Lda.0 个研究点目标入组 1,400 人开始时间: 2010年7月14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
- 1,400
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. 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 immediate release metformin unchanged for 12 weeks prior to randomisation. Minimum dose for metformin: > = 1500 mg/day or maximum tolerated dose (the investigator must have documented the reason why up-titration to >= 1500 mg/day was not possible) or maximum dose according to local label
- •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 1221
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 324
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 immediate release metformin
- •3. Acute coronary syndrome (non-STEMI, STEMI, unstable AP), 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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