Impact of liraglutide on cardiac function and structure in young adults with type 2 diabetes: an open lable, randomised active-comparator trial. - Effects of Liraglutide in Young adults with Type 2 DIAbetes (LYDIA)

niversity of Leicester0 个研究点目标入组 90 人开始时间: 2013年7月23日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•Capacity to provide informed consent before any trial-related activities •Aged 18 – 50 years inclusive •Established T2DM (>12 months) •BMI = 30 kg/m2 (=27 kg/m2 for South Asians or other BME populations) •On mono or combination oral OAD therapy (sulphonylurea and/or metformin) for = 3 months •No prescribed thiazolidinediones within the last 3 months •An HbA1c value of >= 6.5% and <= 10%
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Absolute contraindications to MRI •Type 1 diabetes (identified through C-peptide analysis) •Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods •Suffer from terminal illness •Have impaired renal function (eGFR < 30 ml/min/1.73m2) ) •Impaired liver function (ALAT=2.5 times upper limit of normal) •Known to be Hepatitis B antigen or Hepatitis C antibody positive •Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the investigator •Recurrent major hypoglycaemia as judged by the investigator •Known or suspected allergy to the trial products •Receipt of any investigational drug within four weeks prior to this trial •Have severe and enduring mental health problems •Are not primarily responsible for their own care •Are receiving insulin therapy •Have taken a thiazolidinedione within the last 3 months •Any contraindication to Sitagliptin or Liraglutide •Have severe irritable bowel disorder •Have pancreatitis or a previous history of pancreatitis

发起方

niversity of Leicester