A randomized, 24-week, open-label, 2-arm parallel-group, multicenterstudy comparing the efficacy and safety of insulin glargine/lixisenatide fixed ratio combination versus insulin glargine on top of metformin in type 2 diabetic patients

sanofi-aventis Recherche et Développement0 个研究点目标入组 310 人开始时间: 2011年10月20日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•- Patient with type 2 diabetes mellitus diagnosed for at least 1 year.
•- Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to 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 248
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 62

•- Age < legal age of adulthood
•- Screening HbA1c < 7% or > 10%
•- Screening FPG > 250 mg/dL (> 13.9 mmol/L)
•- Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
•- Type 1 diabetes mellitus
•- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening
•- Use of insulin within the last 6 months
•- Previous use of insulin, except for episode(s) of short-term treatment (= 15 consecutive days) due to intercurrent illness
•- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) at screening
•- Calcitonin = 20 pg/ml (5.9 pmol/l) at screening
•- Alanine Transferase (ALT)> 3ULN at screening
•- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
•- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g multiple endocrine neoplasia syndromes)
•- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively
•- Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures
•- Body Mass Index (BMI) = 20 or > 40 kg/m²
•- Any previous treatment with lixisenatide

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