EUCTR2013-001347-31-ES进行中（未招募）不适用
A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects with Diabetes Mellitus type 2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •?Signed Informed Consent
- •?BMI < 30 kg/m2
- •?History of type 2 diabetes mellitus as confirmed by:
- •?onset of diabetes after 30 years of age
- •?no insulin treatment in the first year after diagnosis
- •?Subjects on insulin treatment or on insulin treatment in combination with oral antidiabetics
- •?HbA1c > 6.5% in medical history within the last 6 months despite insulin treatment
- •?Not previously treated with any pancreatic enzyme supplementation
- •?FE-1 <100?g/g of stool
- •?13C MTBT of <29% 13CO2-CRR
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •?Treatment with systemic steroids for at least 3 weeks within past 6 months
- •?Patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc.
- •?Known allergy to products of porcine origin
- •?Any type of malignancy involving digestive tract in the last 5 years
- •?Any type of gastrointestinal surgery (except appendectomy and gallbladder resection)
- •?Short bowel syndrome
- •?Hemochromatosis
- •?Any history of drug abuse including alcohol
- •?Positive urine pregnancy test; lactation; females of child-bearing potential who are not using either an oral hormonal contraceptive or an intrauterine device
- •?Severe allergy or any history of severe abnormal drug reaction
- •?Intake of an experimental drug within 4 weeks prior to entry into this study
- •?Suspected non-compliance or non-cooperation
- •?History of human immunodeficiency virus (HIV) infection
研究者
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