EUCTR2007-006109-26-DE进行中（未招募）不适用
Impact of Insulin Glargine compared to Insulin Detemir in combination with Metformin (BOT) on prandial beta cell function and overall metabolic control in type 2 diabetic patients with insufficient metabolic control during OAD Treatment - Insulin glargine and prandial beta cell function
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Type 2 Diabetes mellitus according to the ADA criteria
- •2. HbA1c between 6.5 % and 8.5 %
- •3. Monotherapy with metformin or combined with sulfonylurea in a stable dosage within the last 3 months
- •4. Age between 40 and 75 years
- •5. Fasting intact proinsulin level > 7 pmol/L
- •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. Pre-Treatment with insulin within the last 3 months prior to screening
- •3. Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening
- •4. Major micro- or macrovascular complications as judged by the investigator
- •5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- •6. BMI > 45 kg/m²
- •7. Hypokalemia (K < 3.5 mmol /L)
- •8. History of drug or alcohol abuse within the 6 months prior to screening
- •9. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •10. History of severe or multiple allergies
- •11. Treatment with any other investigational drug within 3 months prior to screening
- •12. Progressive fatal disease
- •13. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dL in women and > 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- •14. Pregnancy or breast feeding
- •15. Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy
- •16. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
研究者
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