CTRI/2012/10/003072已完成3 期
The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.A 26 week double blind placebo -controlled randomised multicentre,multinational parallel group trial.
ovo Nordisk AS0 个研究点目标入组 69 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •HbA1c (glycosylated haemoglobin A1c) 7.0â??10.0% (both inclusive)
- •Body mass index (BMI) 20â??45 kg/m2 (both inclusive)
- •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 with or without stable metformin equal to or above 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)
排除标准
- •Female of child-bearing potential who is pregnant, breast-feeding or intending 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 (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
- •Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigatorâ??s opinion could interfere with results of the trial
- •Known or suspected abuse of alcohol or narcotics
研究者
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