iraglutide Effect and Action in Diabetes (LEAD-1): Effect on glycaemic control after once daily administration of liraglutide in combination with glimepiride versus glimepiride monotherapy versus glimepiride and rosiglitazone combination therapy in subjects with type 2 diabetesA six-month double-blind, double-dummy, randomised, active control, parallel-group, multi-centre, multi-national trial

ovo Nordisk A/S0 个研究点目标入组 1,865 人开始时间: 2006年4月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least 3 months
•? 7.0-11.0 % (both inclusive) in subjects on OAD monotherapy
•? 7.0-10.0 % (both inclusive) in subjects on OAD combination therapy
•Age 18-80 years, both inclusive. (as allowed according to local guidelines for glimepiride treatment)
•Body mass index (BMI) = 45.0 kilogram (kg)/square metre (m2)
•At Randomisation:
•Daily use of 4 mg glimepiride for at least 2 weeks
•Mean fasting plasma glucose (FPG) of 7.0-12.8 mmol/L both incl. (126-230 mg/dL both inclusive.)
•Are the trial subjects under 18?
•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

•Treatment with insulin within the last three months prior to the trial (except for short-term treatment with insulin in connection with intercurrent illness at the discretion of the Investigator)
•Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (ULN) (one retest analysed at the central laboratory within a week is permitted with the last sample being the conclusive sample)
•Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females (one retest analysed at the central laboratory within a week permitted with the last sample being the conclusive sample)
•Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class I-IV)
•Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
•Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
•Use of any drug (except for OADs), which, in the Investigator’s opinion, could interfere with the glucose level (e.g. systemic corticosteroids)
•Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).

发起方