An evaluation of the safety and effectiveness of combination therapy using the thiazolidinedione pioglitazone alongside insulin in type 2 diabetes mellitus.

Bradford Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2006年9月29日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Type 2 diabetes treated with insulin +/- metformin +/- sulphonylurea
•Insulin resistant (requiring >0.8U/kg/day insulin) and/or acanthosis nigricans present
•BMI >28kg m-2
•HbA1c >7.0%
•Aged 16 and over
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Consent withheld or withdrawn
•Unable to comply with the treatment schedule (as judged by investigator)
•Current active heart failure (NYHA grade III– IV; see appendix 2 for definition)
•History of hospital admission with heart failure in the last 12 months (from medical records)
•Anaemia at baseline (Hb < 11mg/dl)
•Abnormal liver biochemistry at baseline, defined as ALT >100IU/l (approx. 2.5x upper limit of normal)
•Previous adverse reaction to TZD (any previous exposure with reported adverse effect)
•Women of childbearing potential planning pregnancy or not using contraception

发起方