CTRI/2011/05/001725已完成3 期
A Phase III, multicentre,international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk
Boehringer Ingelheim Pharmaceuticals0 个研究点目标入组 4,000 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 drug-naïve or pre-treated with any background therapy.
- •3. HbA1c of ≥7.0% and ≤ 10% for patients on background therapy or HbA1c ≥7.0% and ≤8.0% for drug-naïve patients.
- •4. Age ≥18 years and ≤ 65 years
- •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
- •7. In addition to the above described criteria, patients must have high cardiovascular risk, defined as at least one of the following:
- •? History of myocardial infarction (2 months prior to informed consent)
- •? Unstable angina (2 months prior informed consent) with documented multivessel coronary disease (of at least two major coronary arteries in angiogram) or positive stress test (ST segment depression ≥2 mm or a positive nuclear perfusion scintigram).
- •? Multivessel Percutaneous Coronary Intervention (PCI) 2 months prior informed consent
- •? Multivessel Coronary Artery By-pass Grafting (CABG) 4 years prior to informed consent or with recurrent angina following surgery
- •? History of ischemic or hemorrhagic stroke (2 months prior to informed consent)
- •? Peripheral occlusive arterial disease (previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due
- •to circulatory insufficiency, angiographic or ultrasound detected significant vessel stenosis (50% stenosis) of major limb arteries)
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
- •2. 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.
- •3. Planned cardiac surgery or angioplasty within 3 months
- •4. Impaired renal function, defined as GFR30 ml/min (severe renal impairment, MDRD formula) as determined during screening and/or run in phase.
- •5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce
- •chronic malabsorption
- •6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g.
- •malaria, babesiosis, haemolytic anemia)
- •7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer
- •within the last 5 years
- •8. Contraindications to background therapy according to the local label
- •9. 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
- •10. 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
- •11. 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 (if allowed by local Authorities), double barrier method and vasectomised partner
- •12. 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
- •13. Participation in another trial with an investigational drug within 30 days prior to informed consent
- •14. Any other clinical condition that would jeopardize patients safety while participating in
- •this clinical trial
研究者
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