EUCTR2012-002271-34-DE进行中（未招募）不适用
A phase III, randomized, double-blind, parallel group study to evaluatethe efficacy and safety of linagliptin 5 mg compared to placebo,administered as oral fixed dose combination with empagliflozin 10 mgor 25 mg for 24 weeks, in patients with type 2 diabetes mellitus andinsufficient glycaemic control after 16 weeks of treatment withempagliflozin 10 mg or 25 mg on metformin background therapy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 690
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 who have received diet and exercise counselling and who are pre-treated with an unchanged dose of immediate release metformin for at least 12 weeks prior to Visit 2.
- •Minimum dose for metformin is defined as:
- •=1500 mg/day of metformin or
- •maximum tolerated dose (the investigator must have documented the reason why uptitration to e.g. = 1500 mg/day was not possible) or
- •maximum dose according to the local label (the investigator must have documented the local label requirements in the medical records)
- •3. HbA1c = 8.0% (64 mmol/mol) and = 10.5% (91 mmol/mol) at Visit 1 for randomization into the 16 week treatment period.
- •4. HbA1c = 7.0% (53 mmol/mol) and = 10.5 % (91 mmol/mol) at Visit 4 for randomization into the 24 week treatment period.
- •5. Age = 18 years
- •6. Body Mass Index (BMI) =45 kg/m2 at Visit 1 (screening) as calculated in the eCRF.
- •7. 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 517
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 173
排除标准
- •1. Uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/L) after an overnight fast during the open label period (from Visit 2 to Visit 4) and placebo add on run-in period (Visit 4 to Visit 5) confirmed by a second measurement (not on the same day and done either at the central or local laboratory).
- •2. Any other antidiabetic drug within 12 weeks prior to Visit 2 randomization (except metformin background therapy as defined via inclusion criterion 2).
- •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) based on Visit 1 or Visit 4 laboratory parameters.
- •Note: Each value should be assessed independently of one another, i.e Visit 1 assessments will determine randomization to the open label treatment period and Visit 4 assessments will determine randomization to the double blind treatment period
- •5. Impaired renal function, defined as eGFR <60 ml/min/1.73 m2 (MDRD formula) as determined during screening (Visit 1) or placebo add on run-in (Visit 4)
- •Note: Each eGFR value should be assessed independently of one another, i.e Visit 1 assessments will determine randomization to the open label treatment period and Visit 4 randomization and assessments will determine randomization to the double blind treatment period
- •6. Known hereditary galactose intolerance
- •7. Known contraindications to metformin or linagliptin according to the local label (where marketed)
- •8. Any previous (within the past two years) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induces 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 haemolysis or unstable red blood cell count (e.g. malaria, babesiosis, haemolytic anaemia) 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 (other than inhaled or topical steroids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other documented 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 vasectomised 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 ongoi
研究者
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