Type II diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
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
Concentration unit: IU/ml international
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.Diagnosis of type 2 diabetes according to clinical judgement 3.Current treatment with one or two OAD(s) (insulin secretagogues, insulin sensitizers, metformin, glitazones, alpha-glucosidase inhibitors) for = 2 months. Subjects on monotherapy should be at least on half maximum dose for = 2 months 4. 7.5% = HbA1c = 11.0% in subjects on OAD monotherapy, and 7.0% = HbA1c = 10.0% in subjects on OAD combination therapy (analysis from central laboratory) 5. FEV1 = 70 % of predicted value 6.Males and females, age = 18 years 7.Body mass index of (BMI) = 40.0 kg/m2 8.Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary 9. Able and willing to be treated with metformin (up to three times daily) in combination with pre-prandial inhaled insulin using the AERx or tablet treatment 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.Previous participation in this trial. Participation is defined as randomisation 2.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. For United Kingdom, adequate contraceptive measures are sterilisation, intra-uterine device, oral contraceptives or consistent use of barrier methods]) 3.Known or suspected allergy to trial products or related products 4.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 5.Chest X-ray with any clinically significant abnormalities evaluated by a radiologist 6.Unresolved symptoms and signs of an upper respiratory tract infection (URTI) within 3 weeks prior to screening 7.Current acute or chronic pulmonary disease (excluding asthma) including chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, sarcoidosis, and pulmonary fibrosis 8.History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator 9.Cardiac disease defined as: decompensated heart failure (NYHA class I to IV), unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on ECG over the past 12 months 10.Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, haematological systems 11.Severe uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg or sitting diastolic blood pressure = 100 mmHg) 12.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) 13.Renal insufficiency defined as serum creatinine = 1.4 mg/dL (= 126 µmol/L) for males and = 1.3 mg/dL (= 111 µmol/L) for females, (one retest within a week is permitted) 14.History of proliferative retinopathy or maculopathy requiring treatment 15.Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine 16.Positive screening for Hepatitis B antigen or Hepatitis C antibody 17.Treatment with systemic steroids within the past 2 months prior to screening 18.Current addiction to alcohol or substances of abuse as judged by the Investigator 19.Any conditions that the Investigator judges would interfere with trial participation or evaluation of results 20.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the trial 21.Participated in another clinical trial and received an investigational drug within the last 4 weeks 22.Previous treatment with inhaled insulin, other than treatment 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® iDMS to rosiglitazone, both in combination with metformin, on glycaemic control (as measured by change in HbA1c from baseline) in subjects with type 2 diabetes, after 26 weeks of treatment.;Secondary Objective: •To assess and compare the effect on fasting plasma glucose (FPG) •To evaluate 8-point plasma glucose profiles •To assess the percentage of subjects achieving HbA1c = 7.5%, = 7.0%, and = 6.5% after 26 weeks •To evaluate the lipid profile •To evaluate body weight changes •To assess the incidence of hypoglycaemic episodes •To assess and compare pulmonary function tests (PFT) •To assess and compare patient reported outcomes (PRO) •To assess and compare health economics parameters •To assess the safety and tolerability ;Primary end point(s): HbA1c change from baseline after 26 weeks of treatment | — |
Countries
Austria, Finland, France, Germany, Ireland, Spain, United Kingdom
Outcome results
None listed