EUCTR2005-005378-58-DK进行中（未招募）不适用
Inhaled pre-prandial human insulin with the AERx® iDMS versus s.c. insulin aspart in type 2 diabetes: A 104-week, open-label, multicentre, randomised trial followed by 12-week re-randomised extension to investigate safety and efficacy
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
- 710
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
- •Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
- •Diagnosis of type 2 diabetes according to clinical judgement
- •Current treatment with any regimen of insulin for = 3 months (with or without a maximum of one OAD)
- •Males and females, age = 18 years
- •Body mass index of (BMI) = 40.0 kg/m2
- •HbA1c = 11.0 % (analysis from central laboratory)
- •Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
- •Able and willing to be treated with a basal regimen (once or twice daily) and bolus regimen (3 times per day)
- •FEV1 = 70 % of predicted value
- •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
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice [for Germany, adequate contraception is: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
- •Total daily insulin dosage > 100 Units
- •Current regular smoking or regular smoking* within the last 6 months
- •*Regular smoking defined as one cigarette or an equivalent amount of smoking tobacco per day or a positive urine cotinine test on laboratory test, except if resulting from non-inhalable tobacco products
- •Chest X-ray with any clinically significant abnormalities evaluated by a radiologist
- •Unresolved symptoms and signs of an upper respiratory tract infection (URI) within 3 weeks prior to screening
- •Current acute or chronic pulmonary disease (excluding asthma) including chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, sarcoidosis, and pulmonary fibrosis
- •History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator
- •Treatment with systemic steroids within the past 2 months prior to screening
- •Impaired hepatic function defined as screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 times upper normal range (one re-test analysed at the central laboratory within one week is permitted with the last sample being conclusive)
- •Clinically significant, active (or over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genitourinary, haematological systems, or has severe uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg or sitting diastolic blood pressure = 100) or history of proliferative retinopathy or maculopathy requiring treatment
- •Renal insufficiency (creatinine = 2 mg/dL; = 180 µmol/L)
- •Participated in another clinical trial and received an investigational drug within the last 4 weeks or received previous treatment with pulmonary insulin other than subjects treated with AERx for more than a total of seven days
研究者
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