Official Title: “Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

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.

Intervention(s) in this Clinical Trial

• Drug: inhaled human insulin
  • Treat-to-target dose titration scheme, pre-prandial, inhalation.
• Drug: metformin
  • Tablets, 2000 mg/day.
• Drug: glimepiride
  • Tablets, 4 mg/day.
• Drug: inhaled human insulin
  • Treat-to-target dose titration scheme, post-prandial, inhalation.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Active Comparator: C

Primary Measures

• HbA1c change from baseline
  • Time Frame: After 18 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Adverse events
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Body weight
  • Time Frame: after 18 weeks of treatment
    Safety Issue?: No
• Lung function
  • Time Frame: after 18 weeks of treatment
    Safety Issue?: No
• Blood glucose
  • Time Frame: after 18 weeks of treatment
    Safety Issue?: No
• Hypoglycaemia
  • Time Frame: after 18 weeks of treatment
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Dorthe Lyngsoe Vuylsteke Study Director Novo Nordisk A/S  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469586

Study ID Number: NN1998-1787

ClinicalTrials.gov Identifier: NCT00469586

Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Clinical Trials at Novo Nordisk