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: 2006年11月13日最近更新: 2022年1月24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 = 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
•- Active proliferative diabetic retinopathy
•- Pregnancy
•- Breast-feeding
•- History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine
•- 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
•- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
•- 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 at study entry
•- Impaired renal function at study entry

发起方

ABORATOIRE AVENTIS