Insulina humana preprandial inhalada con el sistema AERx® iDMS frente a insulina aspart s.c. en diabetes tipo 2: ensayo de 52 semanas de duración, abierto, multicéntrico, aleatorizado seguido de un periodo de extensión de 52 semanas y una extensión de 12 semanas con re-aleatorización para investigar la seguridad y la eficacia.Inhaled pre-prandial human insulin with the AERx® iDMS versus s.c. insulin aspart in type 2 diabetes;
- Conditions
- Diabetes MellitusMedDRA version: 8.1Level: LLTClassification code 10012601
- Registration Number
- EUCTR2005-005378-58-ES
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
• 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
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
• Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (appropriate methods include abstinence and the following methods: diaphragm, condom, (by partner), intrauterine device, sponge, spermacide or oral contraceptives)
• Total daily insulin dosage > 100 Units
• Current smoking or 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 screening laboratory test. Subjects using non-inhalable tobacco products can be included despite a positive urine cotinine test
• 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method