Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- HbA1c change from baseline
Study Overview
Brief Summary
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •Treated with OADs for more than or equal to 3 months
- •HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
- •Body Mass Index (BMI) less than or equal to 40.0 kg/m2
Exclusion Criteria
- •Recurrent major hypoglycaemia
- •Current smoking or smoking within the last 6 months
- •Impaired hepatic or renal function
- •Cardiac problems
- •Uncontrolled hypertension
- •Proliferative retinopathy or maculopathy
Arms & Interventions
A
Intervention: inhaled human insulin (Drug)
B
Intervention: inhaled human insulin (Drug)
C
Intervention: metformin (Drug)
C
Intervention: glimepiride (Drug)
Outcomes
Primary Outcomes
HbA1c change from baseline
Time Frame: After 18 weeks of treatment
Secondary Outcomes
- Lung function(after 18 weeks of treatment)
- Adverse events(For the duration of the trial)
- Body weight(after 18 weeks of treatment)
- Blood glucose(after 18 weeks of treatment)
- Hypoglycaemia(after 18 weeks of treatment)