EUCTR2012-002270-31-NO进行中（未招募）1 期
A phase III, randomised, double-blind, parallel group, 24 week study to evaluate efficacy and safety of once daily empagliflozin 10 mg and 25 mg compared to placebo, all administered as oral fixed dose combinations with linagliptin 5 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks treatment with linagliptin 5 mg once daily on metformin background therapy.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,134
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 an unchanged dose of immediate release metformin for at least 12 weeks prior to screening. Patients should be on =1500 mg/day of metformin or maximum tolerated dose (must be documented) or maximum dose as per local label
- •3.HbA1c = 8.0% and = 10.5% at Visit 1 for entering the 16 week treatment period.
- •4.HbA1c = 7.0% and = 10.5% at Visit 4 for randomisation into the 24 week double-blind treatment period.
- •5.Age = 18 years at screening
- •6.Body Mass Index (BMI) = 45 kg/m2 at Visit 1 (screening)
- •7.Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (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 410
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15 mmol/L) after an overnight fast during the open label treatment period (from Visit 2 to Visit 4) and placebo add on run-in period (Visit 4 to Visit 5) and confirmed by a second measurement (not on the same day and done either at the central or at local laboratory).
- •2.Any other antidiabetic drug within 12 weeks prior to Visit 2 (except metformin background therapy as defined via inclusion criterion 2). Use of other antidiabetic treatment (except study drug and metformin background medication) prior to randomization (Visit 5).
- •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, 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, linagliptin treatment and/or placebo add on run-in” period
- •5.Impaired renal function, defined as eGFR <60 ml/min/1.73m2 (MDRD formula) as determined during screening, linagliptin treatment and/or placebo add on run-in” period
- •6.Known hereditary galactose intolerance
- •7.Known contradications to metformin or linagliptin according to the local label
- •8.Any previous (within the past two years) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induce chronic malabsorption
- •9.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- •10.Known blood dyscrasias or any disorders causing hemolysis or unstable red blood cell count (e.g. malaria, babesiosis, hemolytic anemia) due to the short lifespan of the RBC and its impact on HbA1c.
- •11.Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) within 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 (orally taken or parenteral) 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 =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 trial 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, complete sexual abstinence (if acceptable by local health authorities), double barrier method and vasectomized partner
- •14.Known allergy or hypersensitivity to DPP4 inhibitors or SGLT-2 inhibitors
- •15.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 trial procedures or trial drug intake, in the judgment of the investigator
- •16.Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participation in the follow-up period of another trial (partipation in observational studies is permitted)
- •17.Any other clinical condition th
研究者
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