NCT02009410撤回4 期
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
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Abbott
- 试验地点
- 10
- 主要终点
- Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)
研究概览
简要总结
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 and
- •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
- •Inclusion Criterion at Visit 1:
- •FE-1 (fecal elastase 1) <100μg/g of stool
- •Inclusion Criterion at Visit 2:
- •13C MTBT of <29% 13CO2-CRR (Carbon dioxide-Cumulative Recovery Rate)
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.
- •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
- •Known late onset autoimmune diabetes in the adult
- •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
- •Hypersensitivity to the active substance or to any of the excipients
- •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
研究组 & 干预措施
Creon
Experimental
干预措施: Creon (Drug)
Placebo
Placebo Comparator
干预措施: Creon 25000 matching Placebo (Drug)
结局指标
主要结局
Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon)
时间窗: from baseline up to the week 12 visit
次要结局
- Change in nutritional parameters(from baseline up to the week 12 visit)
- Change in HbA1c(from baseline up to the week 12 visit)
- Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL)(from baseline up to the week 12 visit)
- Change in clinical global impression of disease symptoms(from baseline up to the week 12 visit)
研究者
研究点 (10)
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