The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes

ovo Nordisk A/S0 个研究点目标入组 446 人开始时间: 2012年6月5日最近更新: 2013年12月23日

适应症

试验速览

暂无简介。

•- Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day plus/minus stable metformin above or equal to 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
•- HbA1c 7.0–10.0% (both inclusive)
•- Body mass index (BMI) 20–45 kg/m^2 (both inclusive)
•- Age 18 - 80 years
•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 321
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 125

•- Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant
•- Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
•- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
•- Impaired liver or renal function
•- Uncontrolled treated or untreated hypertension (SBP above or equal to 180 mmHg and/or DBP above or equal to 100 mmHg)
•- Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator’s opinion could interfere with results of the trial
•- Known or suspected abuse of alcohol or narcotics

发起方