EUCTR2012-004984-27-LV进行中（未招募）不适用
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes - LIRA-LIXI™
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •- Males and females age 18 years or older
- •- Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening.
- •- HbA1c 7.5- 10.5% (58 mmol/mol - 91 mmol/mol) (both inclusive).
- •- Body mass index (BMI) equal to or above 20 kg/m^2
- •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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice)
- •- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
- •- History of chronic pancreatitis or idiopathic acute pancreatitis
- •- Screening calcitonin value equal to or above 50 ng/L
- •- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- •- Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)
- •- Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 per Modification of Diet in Renal Disease (MDRD) formula
- •- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
- •- Heart failure, New York Heart Association (NYHA) class IV
- •- Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
- •- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
研究者
相似试验
进行中（未招募）
1 期
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetesMedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2012-004984-27-GBovo Nordisk A/S404
进行中（未招募）
不适用
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2012-004984-27-FIovo Nordisk A/S400
进行中（未招募）
不适用
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2012-004984-27-DEovo Nordisk A/S400
进行中（未招募）
不适用
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetesDiabetes Mellitus, Type 2EUCTR2012-004984-27-HUovo Nordisk A/S400
进行中（未招募）
1 期
Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2012-004984-27-CZovo Nordisk A/S400