EUCTR2006-004731-29-SK进行中（未招募）1 期
Inhaled preprandial human insulin with the AERx® iDMS versus subcutaneous injected insulin aspart in subjects with diabetes and chronic obstructive pulmonary disease: A 52-week, open-label, multicentre, randomised, parallel trial to investigate long-term safety
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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.Able and willing to perform self-monitoring of plasma glucose according to the protocol and able to keep a diary
- •3.Diagnosis of type 1 or type 2 diabetes, i.e.:
- •Type 1 diabetes with an HbA1c = 11.0 % and treated continuously with basal/bolus insulin for at least six months or
- •Type 2 diabetes with an HbA1c = 11.0 % and treated continuously with basal/bolus insulin for at least three months or
- •Type 2 diabetes with an HbA1c = 7.5% and = 11.0 % and treated continuously with basal insulin (with or without an OAD(s) (except rosiglitazone if not approved in combination with insulin) for at least two months or
- •Type 2 diabetes with an HbA1c = 7.5% and = 11.0 % and treated continuously with one or more OADs (except rosiglitazone if not approved in combination with insulin) for at least two months
- •4.Willing to continue on previous antidiabetic treatment
- •5.Males and females, age = 30 years
- •6.Body Mass Index (BMI) = 40 kg/m2
- •7.Clinical diagnosis of stable COPD. The COPD is limited to GOLD stages I-III (see protocol for classification table) and the exact classification is performed by the local pulmonary clinic also responsible for the PFT measurements.
- •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.Participated in another clinical trial and received an investigational drug within the last 4 weeks
- •2.Previous treatment with inhaled insulin (other than AERx for more than a total of seven days)
- •3.Previous participation in this trial. Participation is defined as randomisation
- •4.Current regular smoking or regular smoking within the last six months (regular smoking is 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-inhaled tobacco products)
- •5.Chest X-ray with clinical significant pulmonary abnormalities (excluding changes of COPD) as evaluated by a radiologist
- •6.Unresolved symptoms and signs of an upper respiratory tract infection (URTI) within 3 weeks prior to screening or a current lower respiratory tract infection
- •7.Current or past history of acute or chronic pulmonary disease (excluding COPD - GOLD stage I-III) including asthma, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary fibrosis, lung cancer or a need for long-term oxygen therapy (= 15 hours/day)
- •8.Treatment with systemic steroid within 4 weeks prior to screening
- •9.Known alpha-1-antitrypsin deficiency
- •10.Positive screening for Hepatitis B antigen or Hepatitis C antibody or HIV
- •11.Clinically significant, active (or over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genitourinary, hematological systems
- •12.Creatinine = 2 mg/dL (=180 µmol/L))
- •13.Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- •14.Proliferative retinopathy or maculopathy requiring acute treatment
- •15.Total daily insulin dosage > 100 IU or U per day
- •16.History of hypoglycaemia unawareness and/or recurrent severe hypoglycaemia with more than 2 severe episodes in the past year
- •17. Females of childbearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive
- •methods. Acceptable methods are: diaphragm, condom (by partner), intrauterine device in place for the last three months before trial start,
- •sponge, cap with spermicide, contraceptive path, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the
- •last three months before trial start, post menopausal state or sterilisation or as required by local law or practice
- •18.Impaired liver function, defined as screening aspartate amino transferase (AST) or alanine amino transferase (ALT) =2.5 times upper normal range (one retest analysed at the central laboratory within one week is permitted with the last sample being conclusive)
- •19.Known or suspected allergy to the trial products or related products
- •20.Current addiction to alcohol or substances of abuse as determined by the Investigator
- •21.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the trial
- •22.Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results
研究者
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