Type 2 diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
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 the clinical judgement of the Investigator 3.Current treatment with an insulin secretagogue (sulfonylurea) or metformin at the maximum therapeutic dose for at least 3 months before screening 4.8.0 % = HbA1C =11.0 % 5.Men and women, age =18 years 6.Body Mass Index (BMI) = 40.0 kg/m2 7.FEV1 =70% of predicted value 8.Able and willing to perform self-monitoring of plasma glucose according to the protocol and keep a diabetes diary 9.Able and willing to receive treatment with glimepiride and metformin or change to inhaled human insulin with the AERx insulin device 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 (Visit 2) 2.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 3.Known or suspected allergy to trial product(s) 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 clinically significant pulmonary abnormality or non-pulmonary abnormality that would prevent safe participation in the trial 6.Unresolved symptoms and signs of an upper respiratory tract infection 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.Positive test for Hepatitis B antigen or Hepatitis C antibody at screening 9.Clinically significant, active (or during the past 12 months) disease of the gastrointestinal, neurological, genitourinary, haematological systems 10.Severe uncontrolled treated or untreated hypertension (systolic blood pressure =180 mmHg or diastolic blood pressure =100 mmHg) 11.Proliferative retinopathy or maculopathy requiring acute treatment 12.Cardiac disease defined as: decompensated heart failure, unstable angina pectoris within the past 6 months of trial 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 13.Participation in another clinical trial and has received an investigational drug within the four weeks prior to screening 14.Previous treatment with inhaled insulin other than treatment with AERx for more than a total of seven days 15.History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator 16.Treatment with systemic steroids within the two months prior to screening 17.Impaired renal function defined as serum-creatinine =1.4 mg/dL (=126 µmol/L) for males and =1.3 mg/dL (=111 µmol/L) for females (one re-test analysed at the central laboratory within one week is permitted with the last sample being conclusive) 18.History of acute or chronic lactic acidosis 19.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) 20.Any conditions that the Investigator judges would interfere with trial participation or evaluation of results 21.Current addiction to alcohol or substances of abuse as judged by the Investigator 22.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of periprandial inhaled insulin administered with AERx with the effect of glimepiride and metformin combination therapy, on glycaemic control after 18 weeks of treatment (as measured by change in HbA1c from baseline) in previously inadequately controlled subjects with type 2 diabetes. ;Secondary Objective: To compare the effect of preprandial inhaled insulin administered with AERx with the effect of post-prandial inhaled insulin administered with AERx on glycaemic control after 18 weeks of treatment (as measured by change in HbA1c from baseline) in previously inadequately controlled subjects with type 2 diabetes. •To assess and compare the effect on fasting plasma glucose measured as change in fasting plasma glucose from baseline •To assess and compare the effect on 8-point plasma glucose profiles •To assess and compare the percentage of subjects achieving a HbA1c = 7.5%, = 7.0%, and = 6.5% after 18 weeks of treatment •To assess and compare fasting lipid profile •To assess and compare the effect on body weight •To assess and compare the incidence of hypoglycaemic episodes •To assess and compare health economic parameters and patient reported outcomes (PRO) •To assess and compare pulmonary function tests (PFT) •To assess the safety and tolerability of AERx®iDMS;Primary end point(s): HbA1c change from baseline after 18 weeks of treatment | — |
Countries
Austria, Belgium, Bulgaria, France
Outcome results
None listed