EUCTR2007-003393-25-CZ进行中（未招募）不适用
/A - COBIN2
sanofi-aventis, s.r.o.0 个研究点开始时间: 2007年8月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •1.Men or women, aged from 18 to 80 years inclusive
- •2.Diabetes type 2
- •3.Patients treated NPH insulin with stable dosage of OADs for at least 2 months prior to study start and OADs treatment with metformin at lest 1,7 g /day in combination with sulfonylurea or glinides..
- •4.Patients must have a HbA1c range of = 4,5% ( 6,2% DCCT) and = 8% ( 9,4 % DCCT)
- •5.Ability and willingness to perform CGMS
- •6.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
- •1.Fasting value C peptide = 400 pmol/l
- •2.Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months retinopathy that may require photocoagulation or surgery during the study
- •3.Pregnancy women or women planning gravidity during clinical study protocol
- •4.Breast-feeding
- •5.History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- •6.Treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
- •7.Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •8.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- •9.Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
- •10.Impaired renal function as shown by serum creatinine >/= 133 ?mol/L in men and >/= 124 ?mol/L 1 in women at study entry
- •11.History of drug or alcohol abuse in the last
- •12.Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
- •13.Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
- •14.Patient is the investigator or any sub-investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •15.Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics);
- •16.Patients included in other clinical studies
研究者
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