EUCTR2006-000796-15-FI进行中（未招募）不适用
Inhaled pre-prandial human insulin with the AERx® iDMS plus metformin versus rosiglitazone plus metformin in type 2 diabetes: a 26-week, open-label, multicentre, randomised, parallel trial to investigate efficacy and safety
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
- 448
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. 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)
- •2.Diagnosis of type 2 diabetes according to clinical judgement
- •3.Current treatment with one or two OAD(s) (insulin secretagogues, insulin sensitizers, metformin, glitazones, alpha-glucosidase inhibitors) for = 2 months. Subjects on monotherapy should be at least on half maximum dose for = 2 months
- •4. 7.5% = HbA1c = 11.0% in subjects on OAD monotherapy, and 7.0% = HbA1c = 10.0% in subjects on OAD combination therapy (analysis from central laboratory)
- •5. FEV1 = 70 % of predicted value
- •6.Males and females, age = 18 years
- •7.Body mass index of (BMI) = 40.0 kg/m2
- •8.Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
- •9. Able and willing to be treated with metformin (up to three times daily) in combination with pre-prandial inhaled insulin using the AERx or tablet treatment
- •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.Previous participation in this trial. Participation is defined as randomisation
- •2.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. For United Kingdom, adequate contraceptive measures are sterilisation, intra-uterine device, oral contraceptives or consistent use of barrier methods])
- •3.Known or suspected allergy to trial products or related products
- •4.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
- •5.Chest X-ray with any clinically significant abnormalities evaluated by a radiologist
- •6.Unresolved symptoms and signs of an upper respiratory tract infection (URTI) within 3 weeks prior to screening
- •7.Current acute or chronic pulmonary disease (excluding asthma) including chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, sarcoidosis, and pulmonary fibrosis
- •8.History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator
- •9.Cardiac disease defined as: decompensated heart failure (NYHA class I to IV), unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on ECG over the past 12 months
- •10.Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, haematological systems
- •11.Severe uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg or sitting diastolic blood pressure = 100 mmHg)
- •12.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)
- •13.Renal insufficiency defined as serum creatinine = 1.4 mg/dL (= 126 µmol/L) for males and = 1.3 mg/dL (= 111 µmol/L) for females, (one retest within a week is permitted)
- •14.History of proliferative retinopathy or maculopathy requiring treatment
- •15.Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
- •16.Positive screening for Hepatitis B antigen or Hepatitis C antibody
- •17.Treatment with systemic steroids within the past 2 months prior to screening
- •18.Current addiction to alcohol or substances of abuse as judged by the Investigator
- •19.Any conditions that the Investigator judges would interfere with trial participation or evaluation of results
- •20.Mental incapacity, unwillingness or language barrier precluding adequate understanding or
- •cooperation in the trial
- •21.Participated in another clinical trial and received an investigational drug within the last 4 weeks
- •22.Previous treatment with inhaled insulin, other than treatment with AERx, for more than a total of seven days
研究者
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