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 efficacy

• Conditions: Diabetes Mellitus; MedDRA version: 8.1Level: LLTClassification code 10012601

• Registration Number: EUCTR2005-005378-58-DK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

• 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).
• Diagnosis of type 2 diabetes according to clinical judgement
• Current treatment with any regimen of insulin for = 3 months (with or without a maximum of one OAD)
• Males and females, age = 18 years
• Body mass index of (BMI) = 40.0 kg/m2
• HbA1c = 11.0 % (analysis from central laboratory)
• Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
•Able and willing to be treated with a basal regimen (once or twice daily) and bolus regimen (3 times per day)
• FEV1 = 70 % of predicted value
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

• 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])
• Total daily insulin dosage > 100 Units
• 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
• Chest X-ray with any clinically significant abnormalities evaluated by a radiologist
• Unresolved symptoms and signs of an upper respiratory tract infection (URI) within 3 weeks prior to screening
• Current acute or chronic pulmonary disease (excluding asthma) including chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, sarcoidosis, and pulmonary fibrosis
• History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator
• Treatment with systemic steroids within the past 2 months prior to screening
• 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)
• Clinically significant, active (or over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genitourinary, haematological systems, or has severe uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg or sitting diastolic blood pressure = 100) or history of proliferative retinopathy or maculopathy requiring treatment
• Renal insufficiency (creatinine = 2 mg/dL; = 180 µmol/L)
• Participated in another clinical trial and received an investigational drug within the last 4 weeks or received previous treatment with pulmonary insulin other than subjects treated with AERx for more than a total of seven days

Study & Design

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