EUCTR2005-002614-38-GB进行中（未招募）1 期
COMPARISON OF TWO THERAPEUTIC STRATEGIES FOR TREATING TYPE 2 DIABETIC PATIENTS POORLY CONTROLLED WITH BASAL INSULIN ASSOCIATED WITH ORAL ANTIDIABETIC DRUGS: 6-MONTH PROOF OF CONCEPT STUDY - BASAL PLUS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 196
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. Type 2 diabetic men or women
- •2. Aged 18 to 75 years
- •3. 25 < Body Mass Index (BMI) < 40 kg/m2
- •4. 7,5% = HbA1c = 9%
- •5. Treated with a basal insulin, and at least 1g metformin daily, for more than 3 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
排除标准
- •1. Type 1 diabetes mellitus
- •2. Treatment with OADs ( Oral Antidiabetic Drugs) only
- •3. Treatment with thiazolidinediones, with exenatide or with pramlintide
- •4. Treatment with an insulin other than basal insulin
- •5. Active proliferative diabetic retinopathy
- •6. Pregnancy
- •7. Breast-feeding
- •8. Treatment with systemic corticosteroids in the 3 months prior to study entry
- •9. Previous treatment with insulin glulisine
- •10. Impaired hepatic function at study entry
- •11. Impaired renal function at study entry
研究者
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