Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs. - OSIRIS

ABORATOIRE AVENTIS0 个研究点目标入组 776 人开始时间: 2005年7月27日最近更新: 2022年1月4日

研究概览

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•- Type 2 diabetic men or women
•- Aged 18 to 75 years
•- BMI £ 40 kg/m2
•- 7% < HbA1c £ 11%
•- Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including a sulfonylurea (at a dosage ³ 50% of the maximum recommended dosage) and metformin (at the maximum tolerated dosage), for more than 6 months
•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

•- Type 1 diabetes mellitus
•- Treatment with OADs only
•- Treatment with thiazolidinediones or glinides
•- Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
•- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
•- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
•- Breast-feeding
•- Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration
•- Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine
•- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
•- Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
•- Impaired renal function as shown by serum creatinine >135 µmol/l in men and > 110 µmol/l in women at study entry
•- History of drug or alcohol abuse

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