EUCTR2006-000324-13-GB进行中（未招募）1 期
TARGET GLYCEMIC CONTROL AND THE INCIDENCE OF DOCUMENTED SYMPTOMATIC HYPOGLYCEMIA IN INSULIN NAÏVE SUBJECTS WITH TYPE 2 DIABETES FAILING ON ORAL HYPOGLYCEMIC AGENT(S) AND TREATED WITH LANTUS (INSULIN GLARGINE) OR LEVEMIR (INSULIN DETEMIR): MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, COMPARATIVE, PARALLEL-GROUP STUDY - L2T3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 910
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
- •1.Men or women, aged from 40 to 75 years inclusive
- •2.Type 2 diabetes for at least 1 year
- •3.Insulin naïve
- •4.Treated with stable doses of OADs for at least 3 months prior to study start, including at least metformin (at least 1g/day)
- •5.7% <= HbA1c <=10.5 %
- •6.Body mass index (BMI) < 40 kg/m2
- •7.Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
- •8.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.Type 1 diabetes
- •2.Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
- •3.Treatment with GLP-1 receptor agonists or with DPP-IV inhibitors
- •4.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 (an optic fundus examination should have been performed in the 2 years prior to study entry)
- •5.Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
- •6.Breast-feeding
- •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.Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •11.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- •12.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
- •13.Impaired renal function as shown by serum creatinine >=1.5 mg/dL (>= 133 µmol/L) in men and >= 1.4 mg/dL (124 µmol/L) in women at study entry
- •14.History of drug or alcohol abuse in the last year
- •15.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •16.Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
- •17.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
研究者
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