EUCTR2006-004622-81-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 asthma: a 52-week, open-label, multinational, 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-measurement of plasma glucose (SMPG) according to the protocol and to keep a diary
- •3.Diagnosis of type 1 or type 2 diabetes, ie:
- •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 except rosiglitazone in EU and in countries that follow EU labeling) for at least two months
- •or type 2 diabetes with an HbA1c =7.5 % and = 11.0 % and treated with one or more OAD(s) (except rosiglitazone in EU and in countries that follow EU labeling) for at least two months
- •4.Men and women, age = 18 years
- •5.BMI = 40.0 kg/m2
- •6. Clinical diagnosis of mild intermittent, mild persistent or moderate persistent asthma according to the NAEPP guidelines for at least six months prior to screening
- •7. Stable asthma defined as being on stable prescribed maintenance dose of inhaled glucocorticosteroids* during the last four weeks before Visit 1 and not having had an asthma exacerbation requiring an urgent medical visit initiated by the subject or physician and/or treatment with oral or iv glucocorticosteroids within the last six months before Visit 1
- •* Subjects with mild intermittent asthma should not be treated with inhaled glucocorticosteroids for the last four weeks before Visit 1
- •8. Airway reversibility with inhaled short-acting ß2-agonist according to ATS/ERS guidelines showing an increase in FEV_1 =12% and 200 mL compared to baseline
- •or a positive methacholine or histamine bronchoprovocation test according to local guidelines with PC_20 = 8 mg/mL or PD_20 = 7.8 µmol
- •or a documented airway reversibility test with inhaled short-acting ß2-agonist showing an increase in FEV_1 = 12% and 200 mL compared to baseline within the past three years
- •or a documented positive methacholine or histamine bronchoprovocation test according to local guidelines with PC_20 = 8 mg/mL or PD_20 = 7.8 µmol within the past three years
- •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.Known or suspected allergy to trial products or related products
- •2.Previous participation in this trial. Participation is defined as randomised
- •3.Received an investigational drug within the last 4 weeks
- •4.Previous treatment with inhaled insulin other than AERx for a total of more than seven days
- •5.Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception. Appropriate methods are: diaphragm, condom (by the partner), intrauterine device in place for the last three months before trial start, sponge, cap with spermicide, contraceptive patch, 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 regulations
- •6.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-inhaled tobacco products
- •7. Chest X-ray with pulmonary clinically significant abnormalities (excluding changes due to asthma) as evaluated by a radiologist
- •8. Diagnosis of an upper or lower respiratory tract infection within three weeks prior to screening
- •9.Current acute or chronic pulmonary disease (excluding mild intermittent to moderate persistent asthma)
- •10. Clinical diagnosis of severe persistent asthma according to NAEPP guidelines
- •hospitalisation in the previous year, as judged by the Investigator
- •11.Positive screening for hepatitis B antigen or hepatitis C antibody
- •12.Positive screening for human immunodeficiency virus (HIV)
- •13.Clinically significant, active (or over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, renal (creatinine = 2 mg/dL [= 180 µmol/L], genitourinary or haematological systems
- •14.Sitting diastolic blood pressure (BP) = 100 mmHg and/or systolic =180 mmHg)
- •15.Proliferative retinopathy requiring acute treatment or maculopathy requiring acute treatment
- •16.Total daily insulin dosage > 100 IU or U per day
- •17.History of hypoglycaemia unawareness and/or recurrent severe hypoglycaemia with more than two severe episodes in the past year
- •18.Impaired liver function, defined as screening aspartate aminotransferase or alanine aminotransferase = 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.History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering study drug to the subject
- •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 study
- •22.Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results
研究者
相似试验
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 safetyType 1 DiabetesType 2 DiabetesCOPDMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2006-004731-29-SKovo Nordisk A/S225
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 52-week, open-label, multicentre, randomised trial followed by 52-week extension and 12-week re-randomised extension to investigate safety and efficacy - NDMedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitusDiabetes MellitusEUCTR2005-005378-58-ITOVO NORDISK710
进行中（未招募）
1 期
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 safetyType II diabetesMedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2006-000796-15-FRovo Nordisk A/S
进行中（未招募）
1 期
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 efficacyMedDRA version: 8.1Level: LLTClassification code 10012601Diabetes MellitusEUCTR2005-005378-58-GBovo Nordisk A/S
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 efficacyMedDRA version: 8.1Level: LLTClassification code 10012601Diabetes MellitusEUCTR2005-005378-58-DKovo Nordisk A/S710