A 24-week, multicenter, international, randomized (1:1), parallel-group, open-label, comparative study of insulin glargine versus liraglutide in insulin-naïve patients with Type 2 diabetes treated with oral agents and not adequately controlled, followed by a 24-week extension period with insulin glargine for patients not adequately controlled with liraglutide - EAGLE (Efficacy Assessment of insulin Glargine versus LiraglutidE after oral agents failure)

SANOFI AVENTIS GROUPE0 个研究点目标入组 930 人开始时间: 2010年4月9日最近更新: 2014年3月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: SANOFI AVENTIS GROUPE
入组人数: 930

研究概览入排标准研究者记录与标识符相似试验

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

•Inclusion criteria for the comparative period:
•- Patients aged from 35 to 75 years inclusively,
•- With Type 2 Diabetes diagnosed for at least 1 year,
•- Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DPP-IV inhibitor), for more than 3 months,
•- 7.5% < HbA1c = 12%,
•- BMI between 25 and 40 kg/m2 inclusively ,
•- Ability and willingness to perform PG self monitoring using the sponsor-provided glucose meter and to complete the patient diary,
•- Willingness and ability to comply with the study protocol,
•- Signed informed consent obtained prior to any study procedure.
•Inclusion criteria for the extension period:
•- Patients treated with liraglutide (at the maximum tolerated dosage), having a mean FPG = 250 mg/dL at Visit 10 or Visit 11, or a HbA1c = 7% at Visit 12,
•- Dosage of metformin compliant with the inclusion criterion of Visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Exclusion criteria for the comparative period:
•- Previous treatment with GLP-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization… ),
•- Treatment with thiazolidinediones or a-Glucosidases inhibitors within 3 months prior to study entry,
•- Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake…),
•- Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),
•- Lactating women,
•- Hospitalized patients (except hospitalization for routine diabetes check-up),
•- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,
•- Impaired renal function (creatinine clearance < 60 mL/mn),
•- Impaired hepatic function (ALT, AST = 2.5 times the upper limit of normal range),
•- Personal or family history of medullary thyroid carcinoma,
•- Multiple endocrine neoplasia syndrome type 2,
•- Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),
•- Congestive heart failure,
•- History of acute pancreatitis,
•- Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,
•- Alcohol or drug abuse in the past 5 years,
•- History of sensitivity to the study drugs or to drugs with a similar chemical structure.
•- Night shift worker,
•- Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patient’s safety or limit the patient successful participation in the study.
•Exclusion criteria for the extension period:
•- Treatment with oral antidiabetic drugs other than metformin and patient’s usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),
•- Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period,
•- Pregnant women (women of childbearing potential must have a negative pregnancy test at extension period entry and a medically approved contraception method),
•- Lactating women,
•- Hospitalized patients (except hospitalization for routine diabetes check-up),
•- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence during the comparative period, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the extension period,
•- Impaired renal function (creatinine clearance < 60 mL/mn),
•- Impaired hepatic function (ALT, AST = 2.5 times the upper limit of normal range),
•- History of sensitivity to insulin glargine.

研究者

发起方

SANOFI AVENTIS GROUPE

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