Diabetes Mellitus MedDRA version: 8.1 Level: LLT Classification code 10012601
Conditions
Interventions
Product Name: AERx IDMS
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: Insulin human
CAS Number: 11061-68-0
Current Sponsor code: NN1998
Other descriptive name: AERx IDMS
Concen
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of pre-prandial inhaled human insulin administered with AERx to subcutaneous injections of pre-prandial insulin aspart (both in combination with insulin detemir) on glycaemic control (as measured by change in HbA1c from baseline) in subjects with type 2 diabetes after 52 weeks treatment.;Secondary Objective: To compare… • the effect of pre-prandial inhaled human insulin administered with AERx to subcutaneous injections of pre-prandial insulin aspart on glycaemic control To assess … • the percentage of subjects achieving HbA1c =7.5%, =7.0%, and =6.5% • the proportion of subjects achieving HbA1c =7.0% without symptomatic hypoglycemia • the plasma glucose intra-subject variability • the safety and tolerability To evaluate… • 8-point plasma glucose profiles • the lipid profile • body weight changes • basal/bolus insulin doses • biomarkers To assess and compare… • the effect on fasting plasma glucose • the incidence of hypoglycaemic episodes in the treatment groups • Pulmonary Function Test • Patient Reported Outcomes To investigate… • compliance rates and the correlation between compliance rates and relevant efficacy and safety endpoints • reversibility of changes in insulin antibodies • reversibility of changes in pulmonary function ;Primary end point(s): HbA1c change from baseline after 52 weeks | — |
Countries
Denmark, Germany, Italy, Spain, United Kingdom
Outcome results
None listed