NCT00321321已完成2 期
Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes
University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Insulin Secretion
研究概览
简要总结
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus diagnosed according to WHO criteria
- •Diet and/or metformin treatment
- •HbA1c > 7,0% for metformin treated patients
- •HbA1c > 7,5% for diet treated patients
- •Age: 18 years or older
- •25 > BMI > 40 kg/m2
- •Signed informed consent
- •Sufficient birth control in case of child bearing capacity
排除标准
- •Proliferative retinopathy
- •Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria
- •Liver disease (ALAT > 2 x normal value)
- •CAD (NYHA group III or IV)
- •Positive screening for islet-cell and/or GAD-65 autoantibodies
- •Type 1 diabetes i first degree relatives
- •Gastrointestinal surgery with intestinal resection
- •Pregnancy and/or breastfeeding
结局指标
主要结局
Insulin Secretion
时间窗: 0 - 90 minutes
area under the curve AUC and insulin secretion rate
次要结局
未报告次要终点
研究者
研究点 (2)
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