Treatment of the very insulin resistant obese patient with type 2 diabetes. A 24 week prospective randomised open-label treat-to-target exploratory study comparing the GLP-1 analogue exenatide added to Regular insulin U-500 with U-500 alone.

Dr LA Distiller0 个研究点目标入组 30 人开始时间: 2013年8月14日最近更新: 2023年5月29日

适应症

试验速览

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•Male or female subjects aged 18-75 years;
•A history of type 2 diabetes for at least 1 year defined according to the ADA criteria;
•Total daily insulin requirements of >200 U daily for at least 3 months;
•HbA1c >7.5 %;
•Body Mass Index (BMI) >30 kg/m2;
•Able and willing to understand the protocol and sign informed consent;
•Able and willing to perform SHGM;
•Women of childbearing potential must be willing to use adequate contraception for the duration of the study.

•Pregnancy or planned pregnancy in women of childbearing potential;
•Use of any of the excluded medication as outlined above;
•Any known or suspected underlying endocrinopathy that may be aggravating of causing the insulin resistant state (e.g. Cushings syndrome, acromegaly, glucagonoma etc);
•Any diagnosed chronic inflammatory or systemic autoimmune disorder which may potentiate the insulin resistant state;
•Any clinically significant disease or disorder, except for those conditions associated with type 2 diabetes, which in the investigators opinion could interfere with the results of the study;
•Any patients who, in the opinion of the investigator, are unable to conceptualise and understand the differences between and dosages of U-500 and U-100 insulin;
•Documented significant CVD (unstable angina, heart failure, coronary artery stenting of bypass surgery in past 6 months);
•The presence of an active carcinoma or other chronic illness, which may interfere with glycaemic control or potential longevity;
•Severe renal dysfunction (eGFR <30 ml/min);
•Unable or unwilling to perform SHGM;
•History of gastroparesis or other significant upper gastrointestinal pathology.

发起方

Dr LA Distiller