EUCTR2012-000027-40-DE进行中（未招募）不适用
An open-label, randomized, three-parallel-group study on pharmacodynamic effects of 8-week QD treatment with lixisenatide compared to liraglutide in patients with type 2 diabetes not adequately controlled with insulin glargine with or without metformin.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 with T2DM diagnosed at least 1 year before the screening visit
- •Treatment with neutral protamine hagedorn (NPH) or insulin glargine for at least 3 months and at a stable dose (±20%) of at least 10 IU/day (for at least 2 months prior to screening) alone or combined with a stable dose of metformin with without DPP-4 or sulfonylurea
- •Glycosylated hemoglobin (HbA1c) =6.5 and =9.5%
- •Body mass index (BMI) between 20 and 40 kg/m2
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Pregnant women or breastfeeding women
- •Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening
- •Any previous treatment with lixisenatide or participation in a previous study with lixisenatide (AVE0010), and any previous treatment with liraglutide stopped for safety concern or lack of efficacy
- •Allergic reaction to any GLP-1 agonist in the past (eg, exenatide) or to metacresol
- •History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
- •Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
研究者
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