Efecto y acción de liraglutida en diabetes (LEAD-6): efecto sobre el control glucémico de liraglutida o exenatida en combinación con metformina, sulfonilurea o ambas en sujetos con diabetes tipo 2. Ensayo de 26 semanas, aleatorizado, abierto, con comparador activo, de 2 grupos paralelos, multicéntrico, multinacional con un periodo de extensión de 14 semanas no aleatorizado

ovo Nordisk A/S0 个研究点目标入组 0 人2007年4月24日

适应症diabetes tipo 2 MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: diabetes tipo 2
发起方: ovo Nordisk A/S
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2007年4月24日

结束日期

2009年4月14日

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

ovo Nordisk A/S

入排标准

入选标准

•1\.Informed consent obtained before any trial\-related activities (trial\-related activities are any procedure that would not have been performed during normal management of the subject)
•2\.Subjects diagnosed with type 2 diabetes and treated with either metformin, sulphonylurea or a combination of both, in a stable treatment regimen for at least 3 months prior to screening on maximally tolerated doses of these therapies, at the discretion of the Investigator (short\-term change of metformin or sulphonylurea dose in connection with intercurrent illness within 3 months prior to screening is allowed, at the discretion of the Investigator)
•3\.HbA1c 7\.0\-11\.0% (both inclusive)
•4\.Age 18\-80 years, both inclusive (or as allowed according to local labelling for metformin, exenatide and sulphonylurea treatment)
•5\.Body Mass Index (BMI) \= 45\.0 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
•F.1\.3 Elderly (\>\=65 years) yes

排除标准

•1\.Previous treatment with insulin (except for short\-term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator)
•2\.Previous treatment with exenatide
•3\.Treatment with oral hypoglycaemic agent(s) other than metformin or sulphonylurea in a period of 3 months prior to screening
•4\.Impaired liver function, defined as alanine aminotransferase (ALAT) \= 2\.5 times upper normal limit (one retest analysed at the central laboratory within a week from receiving laboratory results is permitted with the result of the last sample being the conclusive)
•5\.Impaired renal function defined as serum\-creatinine \= 135 µmol/L (\= 1\.5 mg/dL) for males and \= 115 \=mol/L (\= 1\.3 mg/dL) for females, or as allowed according to local guidelines for metformin or sulphonylurea use (one retest analysed at the central laboratory within a week from receiving laboratory results is permitted with the result of the last sample being the conclusive)
•6\.Unstable angina, acute coronary event, other significant cardiac event (including history of arrhythmias or conduction delays on ECG), or cerebral stroke within the past 6 months
•7\.History of heart failure (NYHA class IV)
•8\.Known retinopathy or maculopathy requiring acute treatment as judged by the Investigator
•9\.Uncontrolled treated or untreated hypertension (systolic blood pressure \= 180 mmHg and/or diastolic blood pressure \= 100 mmHg)
•10\.Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the Investigator’s opinion could interfere with the results of the trial