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

Phase 1

• Conditions: Type 1 diabetesType 2 diabetesAsthma; MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-004622-81-SK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-11
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified