EUCTR2012-004096-38-CZ进行中（未招募）不适用
A randomized, open-label, active-controlled, 3-arm parallel-group, 26-week study comparing the efficacy and safety of lixisenatide to that of insulin glulisine once daily and insulin glulisine three times daily in patients with Type 2 diabetes insufficiently 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）
- 入组人数
- 855
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 type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) .
- •Patients treated with basal insulin for at least 6 months.
- •Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and =20 U/day for at least 2 months prior to visit 1.
- •Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (=1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.
- •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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 155
排除标准
- •At screening: age < legal age of majority
- •At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP4 inhibitor and/or a glinide
- •Women of childbearing potential with no effective contraceptive method, pregnancy or lactation
- •Type 1 diabetes mellitus
- •Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
- •Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
- •Any previous treatment with lixisenatide, or any discontinuation from another GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy.
- •At screening, Body Mass Index (BMI) =20 or >40 kg/m².
- •Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
- •Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
- •History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
- •At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg
- •Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
- •Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
- •Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease, if no treatment with metformin
- •At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)
- •At screening ALT or AST>3ULN
- •At screening calcitonin =20 pg/ml (5.9 pmol/L)
- •Exclusion Criteria for randomization at the end of the screening period before randomization:
- •HbA1c <7.0% or >9.0%.
- •7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
- •Amylase and/or lipase > 3 times ULN.
研究者
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