EUCTR2011-002276-16-BE进行中（未招募）1 期
A randomised, double-blind, double dummy study investigating the efficacy and safety of Linagliptin co-administered with metformin QD at evening time versus metformin bid over 14 weeks in treament naive type 2 diabetes and insufficient glycaemic control.
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 1,360 人开始时间: 2011年11月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,360
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 drug-naïve, defined as absence of any oral antidiabetic drugs (OAD) or any injectable antidiabetic therapies for at least 12 weeks prior to randomization
- •3.HbA1c of =7.0% (53 mmol/mol) and =10.0% (86 mmol/mol) at Visit 1 (screening)
- •4.Age =18 and =80 years at Visit 1 (screening)
- •5.BMI =45 kg/m2 (Body Mass Index) at Visit 1 (screening)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •1.Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day)
- •2.Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomisation
- •3.Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
- •4.Indication of liver disease / Impaired hepatic function , 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 ( MDRD formula) as determined during screening 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 hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
- •9.Known history of pancreatitis and chronic pancreatitis
- •10.Contraindications to metformin according to the local label
- •11.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 in the discretion of investigators, 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 T2DM
- •13.Pre-menopausal women (last menstruation > or = 1 year prior to informed consent) who:
- •a.are nursing or pregnant or
- •b.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 or who do not agree to continue contraception for at least 30 days after the last dose of study drug. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
- •14.Alcohol or drug abuse in the discretion of investigators 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 application of any 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 according to investigator’s judgement
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