Phase IV study to evaluate the safety and efficacy of the treatment of hyperglycemia with Gla-300 in basal-bolus regimen in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments and therapy intensification at discharge with basal insulin . - COBALTA

SANOFI-AVENTIS, S.A.0 个研究点目标入组 106 人开始时间: 2016年1月13日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•- Subjects >18 and <75 years old.
•- Previous diagnosis of T2D.
•- Admitted to medical wards with a planned duration of hospitalization of at least 7 days in a haemodynamically stable situation (maximum of 2 weeks).
•- Treated with basal insulin and/or non-insulin treatments prior to admission.
•- Poorly controlled on admission: HbA1c between 8% and 10%.
•- Signed informed consent.
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 46

•- Type 1 Diabetes Mellitus.
•- Admission to hospital for decompensation of diabetes.
•- Any psychiatric or neurological disability preventing follow-up
•- Critical illness.
•- Previous treatment with premix or rapid acting insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week).
•- Glomerular filtration rate (GFR) < 30 ml/min measured by MDRD-4 equation.
•-Very high-risk patients who need mandatory insulin therapy at discharge (Treatment with corticoesteroids or pancreatic insufficiency (Pancreatitis / surgery).
•-Participation in any other study.

发起方

SANOFI-AVENTIS, S.A.