EUCTR2012-002271-34-PT进行中（未招募）不适用
A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy.
nilfarma, Lda.0 个研究点目标入组 690 人开始时间: 2012年10月3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
- 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
- •Patients treated with metformin for at least 12 weeks
- •HbA1c = 8.0% (64 mmol/mol) and = 10.5% (91 mmol/mol) at Visit 1 for the 16 week open label treatment period.
- •HbA1c = 7.0% (53 mmol/mol) and = 10.5 % (91 mmol/mol) at Visit 4 for the 24 week double-blind treatment period.
- •Body Mass Index (BMI) =45 kg/m2 at Visit 1 (screening)
- •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
- •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).
- •Any other antidiabetic drug within 12 weeks prior to Visit 2 randomization (except metformin background therapy)
- •Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
- •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.
- •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)
- •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.
- •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.
- •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.
- •Pre-menopausal women (last menstruation =1 year prior to informed consent) who are nursing or pregnant.
研究者
相似试验
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.EUCTR2012-002271-34-ESBoehringer Ingelheim España, S.A690
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.Diabetes mellitus type 2MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2012-002271-34-ITBOEHRINGER ING.1,843
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.Diabetes mellitus type 2 is the medical condition to be investiagtedMedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002271-34-DEBoehringer Ingelheim Pharma GmbH & Co. KG690
Unknown
3 期
Clinical Study to see effect and safety of linagliptin 5mg compared to inactive drug,given as oral fixed dose combination with empagliflozin 10mg or 25mg for 24 wks,in pts with type 2 diabetes mellitus and uncontrolled glucose levels in bld after 16 wks of trtm with empa 10mg or 25mg & metformin.CTRI/2015/06/005914BoehringerIngelheim India Pvt Ltd690
进行中（未招募）
不适用
Safety and efficacy of the combination of empagliflozin and linagliptin compared to linagliptin alone over 24 weeks in patients with type 2 diabetesType II diabetes mellitusMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2012-002270-31-ESBoehringer Ingelheim España, S.A444