Official Title: “Safety and Efficacy of Inhaled Pre-Prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes”

This trial is conducted in Asia, Europe and Oceania.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (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: rosiglitazone
  • Tablets, 4 mg once or twice a day.
• Drug: inhaled human insulin
  • Treat-to-target dose titration scheme, pre-prandial, inhalation.
• Drug: glimepiride
  • Tablets, 4 mg/day.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• Treatment difference in HbA1c
  • Time Frame: After 26 weeks
    Safety Issue?: No

Secondary Measures

• Adverse events
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• body weight
  • Time Frame: during treatment
    Safety Issue?: No
• Lung function
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Blood glucose
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Hypoglycaemia
  • Time Frame: from 12-26 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• Treated with OAD(s) for more than or equal to 2 months
• Body mass index (BMI) less than or equal to 40.0 kg/m2
• HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
• HbA1c greater than or equal to 7.5 % 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 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

Line Elmoe Glesner Study Director Novo Nordisk A/S  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00343980

Study ID Number: NN1998-1682

ClinicalTrials.gov Identifier: NCT00343980

Health Authority: Russia: Federal Service for Control of Health Care and Social Developme

Clinical Trials at Novo Nordisk