EUCTR2008-007026-19-GB进行中（未招募）1 期
COMPARISON OF A BASAL PLUS ONE INSULIN REGIMEN (INSULIN GLARGINE/INSULIN GLULISINE) WITH A BIPHASIC INSULIN REGIMEN (INSULIN ASPART/INSULIN ASPART PROTAMINE 30/70) IN TYPE 2 DIABETES PATIENTS FOLLOWING BASAL INSULIN OPTIMISATION - LanScape
Aventis Pharma Ltd trading as sanofi-aventis0 个研究点目标入组 780 人开始时间: 2009年4月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 780
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Main inclusion criteria:
- •1.Men or women, aged 18 to 75
- •2.Type 2 diabetes mellitus
- •3.Patients being treated with Lantus® once daily, Levemir once or twice daily or NPH insulin once or twice daily as a single insulin for at least three months
- •4. 11.0% = HbA1c = 7.5%
- •5.BMI < 40
- •6.If patients are taking OADs, the dose must be stable for at least 1 month.
- •7.Ability and willingness to perform blood glucose monitoring using a blood glucose meter and ability and willingness to use a patient diary
- •8.Provision of written informed consent obtained prior to enrollment in the study
- •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
排除标准
- •Main exclusion criteria:
- •1.Type 1 diabetes mellitus
- •2.Current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue) in the 3 month prior to screening
- •3.Treatment with GLP-1 receptor agonists or with DPP-IV inhibitors in the 3 months before screening
- •4.Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before screening or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an appropriate fundus examination performed in the 2 years prior to screening, such as retinal photograph or fundoscopy)
- •5.Unable or unwilling to enter either of the treatment arms
- •6.Women who are pregnant or lactating (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
- •7.History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- •8.Treatment with systemic corticosteroids in the 3 months prior to study entry
- •9.Treatment with any investigational product in the 2 months prior to study entry
- •10.Current treatment with any non-selective beta-blockers
- •11.Likelihood of requiring treatment during the study period with drugs not permitted by this clinical protocol
- •12.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- •13.Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at screening
- •14.Impaired renal function as shown by serum creatinine>150 µmol/l in men or women at screening
- •15.History of drug or alcohol abuse
- •16.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •17.Patient unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, or unlikey to complete the study
- •18.Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or a relative thereof.
研究者
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