EUCTR2010-019968-37-BG进行中（未招募）不适用
A phase III, randomized, double-blind, placebo-controlled, parallelgroup safety and efficacy study of BI 10773 (10 mg and 25 mgadministered orally once daily) during 52 weeks in patients with type 2diabetes mellitus and insufficient glycemic control on MDI insulinregimen alone or with metformin.
Boehringer Ingelheim RCV GmbH&CoKG0 个研究点目标入组 555 人开始时间: 2011年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 555
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 T2DM prior to informed consent.
- •2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin. Insulin therapy must include both basal and prandial insulin. Any type of basal and any type of prandial insulin are allowed. Pre-mixed insulin preparations are not allowed.
- •3. Total prescribed insulin dose must be >60 IU/day at Visit 1 (screening) and should not be changed within 12 weeks prior to randomization by more than 10% from the baseline value at randomization (Visit 3).
- •4. Patients not taking metformin
- •Patients on stable metformin therapy:
- •Daily dose =1500 mg/day or maximum tolerated dose (must be documented) or maximum dose according to the local label.
- •The metformin dose has to be unchanged for 12 weeks before the randomization (Visit 3).
- •5. HbA1c =7.5% and =10% at Visit 1 (screening).
- •6. Age =18 years at Visit 1 (screening).
- •7. Body mass index (BMI) =30 and =45 kg/m² at Visit 1 (screening).
- •8. 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 417
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 138
排除标准
- •1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by second measurement (not on the same day).
- •2. Any other antidiabetic drug within 12 weeks prior to randomization except those mentioned in inclusion criterion 2.
- •3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months prior to informed consent.
- •4. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), or alkaline phosphatase above 3 times upper limit of normal (ULN) as determined during screening or run-in period.
- •5. Impaired renal function, defined as GFR <60 ml/min (MDRD formula) as determined during screening and/or run-in period.
- •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) or treatment for cancer within the last 5 years.
- •8. Known blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, hemolytic anemia).
- •9. Any contraindications to metformin according to the local label for those patients who entered the study with metformin therapy.
- •10. Treatment with anti-obesity drugs 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.
- •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 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 acceptable by local authorities), double barrier method and vasectomized 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. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial; or participating in another trial (involving an investigational drug and/or follow-up) after discontinuing medication in this trial.
- •15. Any other clinical condition that would jeopardize patients' safety while participating in this clinical trial.
研究者
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