Type 1 diabetes Type 2 diabetes Asthma MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate long-term pulmonary safety profiles comparing preprandial inhaled human insulin with preprandial subcutaneous (sc) injections of insulin aspart, both in combination with basal insulin and/or oral antidiabetic drugs (OADs), in subjects with diabetes and asthma.;Secondary Objective: The secondary objectives are to compare the two treatment groups with respect to: •Long-term safety profiles as measured by electrocardiogram (ECG), funduscopy/fundusphotography, vital signs, physical examination, body weight, laboratory assessments and adverse events (AEs) •Incidence of hypoglycaemic episodes •Glycaemic control as measured by HbA1c and fasting plasma glucose analysed by central laboratory (FPGLab) •Bolus insulin doses •PROs: asthma control questionnaire (ACQ), insulin treatment satisfaction questionnaire (ITSQ) and environmental tobacco smoke questionnaire (ETS-Q) ;Primary end point(s): Changes in PFTs: FEV_1, FVC, FRC, RV, TLC, and D_L,CO as percent of predicted value from baseline (Visit 2) to 52 weeks of treatment Frequency of asthma exacerbations during 52 weeks of treatment Frequency of night-time awakenings due to asthma during 52 weeks of treatment Frequency and doses of asthma medication during 52 weeks of treatment Changes in X-ray from baseline (Visit 2) to 52 weeks of treatment | — |
Countries
Slovakia
Outcome results
None listed