Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
Detailed description
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.
Interventions
DRUGrosiglitazone
Tablets, 4 mg once or twice daily.
Treat-to-target dose titration scheme, inhalation.
DRUGmetformin
Tablets, 2000 mg/day.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Treated with OAD(s) for more than or equal to 2 months * Body mass index of (BMI) less than or equal to 40.0 kg/m2 * HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy
Exclusion criteria
* Recurrent major hypoglycaemia * Current smoking or smoking within the last 6 months * Impaired hepatic or renal function * Cardiac disorders * Uncontrolled hypertension * Proliferative retinopathy or maculopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment difference in HbA1c | After 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Body weight | For the duration of the trial |
| Lung function | For the duration of the trial |
| Blood glucose | For the duration of the trial |
| Hypoglycaemia | For the duration of the trial |
| Adverse events | For the duration of the trial |
Countries
Austria, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed