NCT01973231已完成4 期
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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% (53 mmol/mol - 91 mmol/mol) (both inclusive)
- •Body Mass Index (BMI) equal to or above 20 kg/m^2
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 below 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 m^2 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)
研究组 & 干预措施
Metformin + liraglutide 1.8 mg
Experimental
干预措施: liraglutide (Drug)
Metformin + lixisenatide 20 microg
Active Comparator
干预措施: lixisenatide (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) From Baseline
时间窗: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of treatment.
次要结局
- Change in Fasting Plasma Glucose (FPG) From Baseline(Week 0, week 26)
- Change in Body Weight From Baseline(Week 0, week 26)
- Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)(After 26 weeks of treatment)
- Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)(After 26 weeks of treatment)
- Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)(After 26 weeks of treatment)
- Number of Treatment Emergent Adverse Events (TEAEs)(Weeks 0-26)
研究者
研究点 (1)
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